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November 13, 2023
Recor's Paradise Renal Denervation System Gets FDA Approval
The Recor Paradise Renal Denervation System
The Paradise system is manufactured by Recor Medical, headquartered in Palo Alto, California and is a wholly-owned subsidiary of Japan-based Otsuka Medical Devices Co., Ltd. The Paradise RDN system had been approved for the CE Mark in Europe over a decade ago, as have several other systems from Medtronic, et al, but this is the first system that has received approval to be marketed in the U.S.

October 21, 2023
New Shockwave IVL Catheter to Debut at #TCT2023
Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) catheter
Shockwave Medical, will be introducing their latest iteration of the intravascular Lithotripsy Catheter, the C2+, just approved by the U.S. FDA. The C2+ provides 50% more pulses and, according to Dr. Richard Shlofmitz of St. Francis Hospital in Roslyn, NY,"will be an added benefit of IVL for optimally treating complex calcium, including more diffuse disease, as well as nodular and thick, eccentric calcium."

October 12, 2023
Medtronic's Evolut FX TAVI System Gets CE Mark
Medtronic's Evolut FX
TAVI system
Medtronic today announced that its latest iteration of the Evolut TAVI/TAVR system, the Evolut™ FX, has received the CE (Conformité Européenne) Mark. Although medical devices often are approved in Europe prior to US approval, the Evolut FX did the opposite: it garnered US FDA approval two years ago. Today's announcement means that this newest and most advanced transcatheter platform for treating severe aortic stenosis will now be available in Europe and beyond.

September 21, 2023
"It's Time!" Say the Major Cardiology Organizations Regarding a Change to the Process of Physician Certification
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By "It's Time!" they mean they no longer wish to be subject to certifiication by the American Board of Internal Medicine (ABIM). By "It's Time!" they are addressing the long-standing complaints of a wide range of cardiologists who claim that the certification requirements of ABIM are not in any way related to their day-to-day practice, are needlessly time-consuming, and are expensive. By "It's Time!" they want a new organization to be in charge of certifying cardiologists.

September 6, 2023
Boston Scientific Announces FDA Approval for the Latest-Generation WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device
Boston Scientific's Watchman FLX Pro
Designed to further advance the procedural performance and safety of the WATCHMAN technology, which is indicated to reduce stroke risk in patients with non-valvular atrial fibrillation (NVAF) who need an alternative to oral anticoagulation therapy, the device now features a polymer coating, visualization markers and a broader size matrix to treat a wider range of patients.

August 11, 2023
Interview with Dr. B. Clay Sizemore About Calcium Modification with IVL in Hospitals That Do Not Have Surgical Backup
Dr. B. Clay Sizemore
In this interview, Dr. Sizemore discusses how intravascular lithotripsy (IVL) has been a game-changer for patients with significant calcified lesions -- that instead of having to transport them to a distant hospital, he is able to safely and efficaciously treat them in Thomasville, Georgia.


August 2, 2023
Centers For Medicare & Medicaid Services Creates New Hospital Inpatient Payment for Coronary Intravascular Lithotripsy
Shockwave Medical’s Intravascular Lithotripsy System
Shockwave Medical, Inc. (NASDAQ: SWAV) announced today that as part of the Fiscal Year 2024 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule, the Centers for Medicare & Medicaid Services (CMS) has created new Medicare Severity Diagnosis Related Group (MS-DRG) codes and payments for coronary Intravascular Lithotripsy (IVL) in the hospital inpatient setting.

May 18, 2023
Shockwave: Dual Announcements at EuroPCR -- New Improved Catheter and 1st Patient Enrolled in All-Female EMPOWER Study
Drs Margaret McEntegart and Richard Shlofmitz
During EuroPCR, the Company introduced to the international market their latest iteration of the calcium-cracking coronary catheter: the C2+ which affords greater numbers of pulses to treat longer and more challenging lesions. Additionally Shockwave announced that the first patient had been enrolled in the EMPOWER study of the treatment of calcified lesions in women, who historically have had less favorable outcomes in the treatment of coronary artery disease.

May 3, 2023
SCCT Honors Dr. Martha Gulati with 2023 Arthur S. Agatston Award
Dr. Martha Gulati
The Society of Cardiovascular Computed Tomography (SCCT) Board of Directors is proud to announce that Martha Gulati, MD, FACC, FAHA, FASPC, FESC has been named the recipient of the 2023 Arthur S. Agatston Cardiovascular Disease Prevention Award for her extensive contributions to the study of women and cardiac diseases and to efforts to improve women’s healthcare.

May 1, 2023
Medtronic Receives FDA Approval For Its Next Generation Micra Leadless Pacing Systems
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Medtronic plc (NYSE: MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval of its Micra™ AV2 and Micra™ VR2, the next generation of its industry-leading miniaturized, leadless pacemakers. Micra AV2 and Micra VR2, the world's smallest pacemakers, provide longer battery life and easier programming than prior Micra pacemakers, while still delivering the many benefits of leadless pacing such as reduced complications compared to traditional pacemakers.

March 14, 2023
Shockwave Medical Announces U.S. Launch of New Peripheral IVL Catheter
Shockwave Medical’s Intravascular Lithotripsy System
The Shockwave L6 catheter is purpose-built to modify calcification in otherwise difficult-to-treat lesions in large peripheral vessels, including the iliac and the common femoral arteries. Calcification in these arteries is common and associated with decreased procedural success and increased complications with standard endovascular techniques. The catheter’s compact emitter configuration, in conjunction with four new device sizes (8.0, 9.0, 10.0 and 12.0 millimeter diameters), enables effective delivery of sonic pressure waves in larger vessels.

March 5, 2023
Three-Year Results of Medtronic's Evolut TAVR Compared to Surgery in Low Risk Patients Presented at ACC
Medtronic's CoreValve/Evolut™ Transcatheter Aortic Valve
The 3-year comparative data for Medtronic's CoreValve/Evolut TAVR vs. SAVR for low risk patients that were presented at today's late-breaking clinical trials session were much needed and the results showed that this device compared favorably with surgery and, in some respects, was superior.


March 4, 2023
New Data Show Superiority of Abbott's TriClip™ Device Compared to Medical Therapy for Tricuspid Regurgitation
Abbott's TriClip
Late-breaking data presented at the 2023 meeting of the American College of Cardiology demonstrated TriClip was superior to medical therapy with significant improvements in quality of life and tricuspid regurgitation (TR). Findings show TriClip, an investigational device in the U.S. to treat a leaky tricuspid valve, demonstrated safety and met the primary endpoint.

March 2, 2023
CathWorks Announces Key Events for ACC 2023
CathWorks FFRangio® System
The CathWorks FFRangio® System, which provides a drug-free and wire-free intraprocedural physiological assessment for the entire coronary tree, will be featured prominently during ACC. Several scientific sessions will focus on angio-based FFR demonstrating its growing role in the marketplace in managing patients with coronary artery disease.

February 28, 2023
Late-Breaking Data Reinforce Benefits of Abbott's Minimally Invasive Heart Devices
Abbott's Amplatzer Amulet Left Atrial Appendage Occluder and Navitor Transcatheter Aortic Valve
Abbott (NYSE: ABT) today announced late-breaking data for its next-generation Navitor™ transcatheter aortic valve implantation (TAVI) system. Results from the study supported Navitor's recent U.S. Food and Drug Administration (FDA) approval to treat people with severe, symptomatic aortic stenosis who are at high or greater risk for open-heart surgery.


February 27, 2023
Medtronic CoreValve/Evolut™ Demonstrates Best Durability
Medtronic's CoreValve/Evolut™ Transcatheter Aortic Valve
Medtronic today announced five-year bioprosthetic valve dysfunction (BVD) data for the CoreValve/Evolut™ platform, the first and only transcatheter aortic valve replacement (TAVR) platform to show significantly better valve performance and durability compared to surgical aortic valve replacement (SAVR) at five years. Data, presented by Dr. Steven Yakubov, in a late-breaking clinical trial session at the 2023 annual meeting of Cardiovascular Research Technologies (CRT 2023), build upon the excellent results of the structural valve deterioration (SVD) analysis recently published in JAMA Cardiology.

February 1, 2023
Medtronic Continues to Make Significant Advances as an Inclusion, Diversity & Equity Leader

Medtronic Diversity
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced that it joins 483 other global companies as a member of the 2023 Bloomberg Gender-Equality Index (GEI), a modified market capitalization-weighted index developed to gauge the performance of public companies dedicated to reporting gender-related data.


January 31, 2023
Updated SCAI Guidance Includes Coronary IVL as a Treatment Option in All U.S. Catheterization Labs Regardless of Surgical Backup Status
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Shockwave Medical, Inc. (NASDAQ: SWAV) today announced that coronary IVL was included in a treatment guidance document published by the Society of Cardiovascular Angiography and Intervention (SCAI) as a potential therapeutic option in all U.S. catheterization labs. - including facilities without on-site surgical backup.


January 11, 2023
Medtronic Announces First Enrollment in Head-to-Head Global Randomized Trial Evaluating Durability of Endovascular Aneurysm Repair
Medtronic's Endurant aortic stent graft
The ADVANCE Trial is a global, post-market, prospective, interventional, multicenter, randomized study that will enroll a minimum of 550 patients at up to 50 centers globally. Patients will be randomized to receive endovascular aneurysm repair (EVAR) with either the Endurant family or Excluder family grafts and will be followed at one month, one year, and annually through five years.

December 5, 2022
Medtronic Completes Enrollment in Pivotal Trial Evaluating First-Of-Its-Kind Pulsed Field Ablation Catheter for Patients with Atrial Fibrillation
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Medtronic (NYSE:MDT) today announced the completion of enrollment and final treatment in the SPHERE Per-AF Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial designed to evaluate the safety and effectiveness of the first-of-its kind Sphere-9™ pulsed field (PF) and radiofrequency (RF) ablation, and high density (HD) mapping catheter with the Affera cardiac mapping and navigation platform for the treatment of persistent atrial fibrillation (AF).

November 29,2022
Medtronic’s Next-Gen Evolut™ FX TAVR System Shows Significant Improvement in Commissure Alignment in Real World Setting
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Medtronic’s newest generation self-expanding, transcatheter aortic valve replacement (TAVR) system, Evolut™ FX, significantly improved commissure alignment during TAVR procedures compared to earlier generation Evolut systems. A late breaker presentation at PCR London Valves 2022 summarized the early limited market release experience with the Evolut FX system in 168 patients from six US centers.

November 27, 2022
Late-Breaking Post-Market Study Data Reinforce Clinical Procedural Success and Safety of the ACURATE neo2™ Aortic Valve System
Boston Scientific's ACURATE neo2 transcatheter aortic valve
Boston Scientific Corporation (NYSE:BSX) has announced the first results from the ACURATE neo2 Post Market Clinical Follow-up (PMCF) study evaluating the performance of the ACURATE neo2™ Aortic Valve System. The findings, which included a high procedural success rate of 98.4% and low rates of mortality and paravalvular leak (PVL), were presented during a late-breaking clinical trial session at PCR London Valves 2022 and published simultaneously in EuroIntervention.

November 7, 2022
SPYRAL HTN-ON MED Study Demonstrates Meaningful Clinical Benefits Consistent with Other SPYRAL HTN Renal Denervation Trials
Medtronic Symplicity Spyral Renal Denervation System
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced the six-month results from the full cohort of the SPYRAL HTN-ON MED clinical trial. The data were presented today as Late-Breaking Clinical Science at the American Heart Association (AHA) Scientific Sessions 2022. With this news, Medtronic has submitted the final module of the Symplicity Spyral™ Premarket Approval (PMA) package to the U.S. Food and Drug Administration (FDA) for review and approval.

November 2, 2022
Clinical Studies Show Medtronic Drug Coated Balloon Outperforms Bare Metal Stents; Maintains Performance in Real World
Medtronic's IN.PACT Drug Coated Balloon (DCB)
Medtronic today announced the results of two clinical studies on the use of the IN.PACT™ Admiral™ drug-coated PTA balloon catheter (DCB). These results were presented in late-breaking clinical trial sessions at VIVA 2022 in Las Vegas. One presented a pooled analysis of DCB verses bare metal stents (BMS) and the other reviewed clinical outcomes of DCB treatment for in-stent restenosis in a high-risk, real-world cohort.

September 21, 2022
Medtronic is the First and Only Company to Receive FDA Indication for Bifurcation Percutaneous Coronary Intervention with a Drug-Eluting Stent
Bifurcation using Onyx Frontier DES
Medtronic announced today that it has received Food and Drug Administration (FDA) approval for the treatment of non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique (using a single stent to treat the bifurcation) with the Onyx Frontier™ drug-eluting stent (DES) and the Resolute Onyx™ DES. This indication will allow Medtronic to provide a robust portfolio of medical education and procedural training for physicians performing percutaneous coronary interventions (PCIs) in patients with bifurcation lesions.

September 20, 2022
Medtronic Receives FDA Clearance for Expanded Indication of LINQ II™ Insertable Cardiac Monitor for Use in Pediatric Patients Ages 2 and Older
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Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced the LINQ II™ Insertable Cardiac Monitor (ICM) system is the first-and-only ICM to receive 510(k) clearance by the U.S. Food and Drug Administration (FDA) for use in pediatric patients over the age of 2 who have heart rhythm abnormalities and require long-term, continuous monitoring.

September 19, 2022
Shockwave Medical Initiates All-Female Coronary IVL Study
Shockwave Medical’s Intravascular Lithotripsy System
EMPOWER CAD is the 1st prospective, female-only study of coronary interventions. The study seeks to confirm benefits of Shockwave’s coronary IVL in females who historically have suffered less favorable clinical outcomes than male patients with traditional therapies. The study is headed by two female co-principal investigators, Drs. Alexandra Lansky and Margaret McEntegart, and will have a prevalence of female site investigators in the U.S. and Europe.

September 18, 2022
TCT 2022: SYMPLICITY HTN-3 Trial Data Show Sustained Long-Term Blood Pressure Reductions With Medtronic Renal Denervation Procedure
Symplicity Renal Denervation System
Subjects who underwent radiofrequency renal denervation (RF RDN) with the first generation Symplicity™ renal denervation system, had a statistically significant reduction in office and ambulatory blood pressure compared to subjects in the sham control group. The data were presented today as Late-Breaking Clinical Science at the 34th Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation, and published simultaneously in The Lancet.

September 16, 2022
Medtronic Announces Full Market Launch in U.S. of Evolut™ Fx Next-Gen TAVR System for Treatment of Symptomatic Severe Aortic Stenosis
Medtronic’s Next-Gen Evolut™ FX TAVR System
The Evolut FX system maintains the industry-leading hemodynamic (blood flow) and durability of the Evolut platform with meaningful design changes. These updates include gold markers built into the frame to provide implanters with direct visualization of commissure alignment; a redesigned catheter tip for a smoother insertion profile; and a more flexible delivery system that features an optimized stability layer for a more stable, predictable deployment. Like its predecessor (Evolut PRO+), the newest system includes four valve sizes for the largest indicated patient treatment range and the lowest delivery profile currently on the market.

August 24, 2022
Medtronic Launches Newest Drug-Eluting Stent: The Onyx Frontier™
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The major improvement is that it employs a more deliverable system: an innovative dual-layer balloon, a lower profile for crossing, and increased catheter flexibility. These refinements point to a 16% improvement in deliverability vs. the previous generation while maintaining superior radial strength.


August 1, 2022
New US Population Study Projects Steep Rise in Cardiovascular Diseases by 2060
Projected Number of Patients in U.S. with Ischemic Heart Disease 2025-2060
Study projects substantial changes in the prevalence of CV risk factors and disease in the U.S. population by 2060, with an increasing prevalence among Black and Hispanic populations who have historically experienced poor access to quality health care. Targeted efforts toward improved screening and equitable access to quality health care in populations with the greatest growth in CV risk factors or disease would be expected to have a substantial impact to reduce future CV risk for the population overall.

July 17, 2022
Non-Invasive FFR Gets Boost from Medtronic
FFRangio Display
FFRangio was developed by CathWorks, an Israeli company, and was approved by the US FDA in 2018, and a year later by the Ministry of Health, Labour and Welfare in Japan. The pivotal study that led to FDA approval, FAST-FFR, showed that angiography-derived FFR was highly accurate when compared with pressure-wire FFR. This week Medtronic announced that it was investing $75 million in the company, co-promoting its use, and has an option to acquire CathWorks for $585 million, once certain milestones are met.

June 9, 2022
Two-Year Results from Onyx ONE Trial: No Difference Between Onyx DES and BioFreedom DCS
Medtronic's Onyx Drug-Eluting Stent (DES)
The results, consistent with the outcomes seen at one year, showed that at two years there were no differences between HBR patients on one month of DAPT who received the Onyx permanent polymer drug-eluting stent (DES), made by Medtronic, and those who received the BioFreedom polymer-free drug-coated stent (DCS), made by Biosensors.


June 8, 2022
Late-Breaking Data Reinforce Broad Range of Patients Benefit from Abbott's Mitral and Tricuspid Heart Valve Devices
MitraClip, manufactured by Abbott
Abbott today announced late-breaking data for MitraClip™, the world's first transcatheter edge-to-edge repair (TEER) device, and TriClip™, a first-of-its kind minimally invasive tricuspid heart valve repair device. The data reinforce the capabilities of the company's structural heart solutions for both mitral and tricuspid regurgitation (MR and TR) across a broad range of patient groups battling leaky heart valves

May 29, 2022
Renal Denervation for Controlling Hypertension Featured at EuroPCR
Panel discusses renal denervation at EuroPCR 2022
At this year's EuroPCR meeting in Paris, the largest European conference in the field of interventional cardiology, the topic of renal denervation (RDN) resurfaced with significant positive results from several trials across devices. The bottom line was that in these sham-controlled trials, renal denervation provided an additional therapeutic avenue for those patients who are unable to control their hypertension with lifestyle changes and medications. In all the studies presented, RDN lowered blood pressures whether the patient was on or off medications.

May 27, 2022
Medtronic Low-Profile Drug-Coated Balloon Platform Receives U.S. FDA Approval to Treat Peripheral Arterial Disease
Medtronic's IN.PACT AV Drug Coated Balloon (DCB)
Medtronic today announced approval from the U.S. Food and Drug Administration (FDA) for the IN.PACT™ 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, a drug coated balloon (DCB), indicated for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries.


May 23, 2022
Shockwave Medical and Genesis MedTech Obtain Regulatory Approval in China for Intravascular Lithotripsy
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Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, and Genesis MedTech Group announced today that they have successfully obtained approval from China’s National Medical Products Administration (NMPA) to market and sell the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheters and the Shockwave M5 and S4 Peripheral IVL Catheters in China.

May 21, 2022
Significantly Improved Results for Medtronic's Evolut TAVR seen in the Optimize PRO Study
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At this year's EuroPCR meeting, the interim results of the Optimize PRO study of Medtronic's Evolut™ PRO and PRO+ TAVR systems in 400 patients were presented as a Hotline Trial: permanent pacemaker rates dropped to single digits (9.2%) and the number of patients with moderate or severe paravalvular leak (PVL) was zero (78% of patients had no or only trace PVL). Moreover, the median length of hospital stay was one day.

May 19, 2022
Intravascular Lithotripsy May Emerge as a First-Line Therapy for Calcified Lesions in Women
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“Given the established safety profile of IVL and the high rates of acute and long-term adverse events in women undergoing PCI, with or without atheroablation of calcified lesions, coronary IVL is an attractive treatment option for optimizing outcomes in our female patients,” said Alexandra Lansky, MD, FACC, FAHA, FSCAI, FESC, Professor of Medicine (Cardiology); Director of Yale Cardiovascular Clinical Research Program, Yale University School of Medicine, New Haven, Conn. “While this is the first one-year analysis of its kind for coronary IVL, the sustained benefit in MACE at one year suggests that IVL should be considered first-line therapy for plaque modification in women with calcified lesions.”

May 18, 2022
ITAL-neo Registry: Boston Scientific's ACURATE neo2 Valve Significantly Reduces Paravalvular Leak (PVL) from 1st Generation Device
ACURATE neo2™ Aortic Valve System
On the first day of this year's EuroPCR meeting in Paris, Dr. Andrea Buono presented the 90-day results from the ITAL-neo registry, a retrospective observational multi-center study, comparing outcomes from Boston Scientific's first generation ACURATE neo transcatheter aortic valve replacement (TAVR) system with those from the newer ACURATE neo2 device. By adding a taller external skirt for the newer device, the PVL was reduced from 11.2% down to 3.5%.

May 13, 2022
Medtronic Receives FDA Approval for Latest Generation Drug-Eluting Coronary Stent System
Medtronic's Onyx Frontier Drug-Eluting Stent
Design changes include increased catheter flexibility, an innovative dual-layer balloon technology and a lower crossing profile, leading to a 16% improvement in deliverability vs. the previous generation Resolute Onyx DES. Onyx Frontier offers a broad size matrix to treat more patients and is the only 2.0 mm DES available in the United States (similar to Resolute Onyx). Further, Onyx Frontier continues to provide 4.50-5.00 mm sizes that can be expanded to 6.00 mm - specifically designed to support extra-large vessels.

May 2, 2022
Medtronic Announces First Enrollment in Pivotal Trial of Patients with Moderate, Symptomatic Aortic Stenosis
Shonan Kamakura General Hospital
Medtronic today announced the first patient enrollment in the EXPAND TAVR II Pivotal Trial, the first randomized clinical trial evaluating the self-expanding, supra-annular Evolut™ TAVR platform in patients with moderate, symptomatic aortic stenosis (AS), a population outside of current guidelines and indications for transcatheter aortic valve replacement (TAVR). The first patient in the EXPAND TAVR II pivotal trial was enrolled by the team led by Shigeru Saito, M.D. and Tomoki Ochiai, M.D. at Shonan Kamakura General Hospital in Kamakura, Japan.

April 27, 2022
IN.PACT™ AV Drug-Coated Balloon First and Only to Show Sustained and Superior Performance Compared to PTA Through 36 Months
Medtronic's IN.PACT AV Drug Coated Balloon (DCB)
Medtronic, the global leader in medical technology, today announced new randomized controlled data demonstrating the sustained and superior performance of IN.PACT AV drug coated balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) through 36 months, with no difference in mortality. The data was presented today as a podium first at the 2022 Charing Cross Symposium in London.

April 25, 2022
Medtronic Names New Chief Scientific, Medical, and Regulatory Officer
Dr. Laura Mauri
This appointment adds to Dr. Mauri's prior responsibilities as chief clinical and regulatory officer, aligning and integrating the company's scientific, medical, clinical research and regulatory affairs under her leadership. It leverages her deep expertise and understanding of the interaction between patients and medical technology to accelerate innovation that puts patients first.

April 21, 2022
Biosensors International Announces Japanese PMDA Approval for BioFreedom™ Ultra and US FDA Approval for BioFreedom™ Biolimus A9™ Coated Polymer Free Coronary Stent Systems
LEADERS FREE: BioFreedom DCS = 50% Reduction in TLR Over Bare Metal Stents at 390 Days

Biosensors is pleased to announce both Japanese PMDA Approval for BioFreedom™ Ultra on 31st March 2022 and also US FDA approval for BioFreedom™ on 14th April 2022. BioFreedom™ is Biosensors’, novel polymer and carrier-free DCS with their proprietary limus drug Biolimus A9™(BA9™). BA9™ is Biosensors’ proprietary highly lipophilic anti-restenotic drug, developed specifically for use in coronary vascular applications. BioFreedom™ gives physicians the opportunity to reduce DAPT to one month in patients post-PCI who are at High Bleeding Risk (HBR).

April 4, 2022
Medtronic TAVR Platform First and Only To Demonstrate Durability Benefit Over SAVR At 5 Years
Medtronic's CoreValve/Evolut TAVR
Medtronic today unveiled new insights from a pooled analysis of high and intermediate risk patients from the CoreValve/Evolut program, showing a lower occurrence in structural valve deterioration (SVD) in patients with severe aortic stenosis (AS) at high or intermediate surgical risk undergoing supra-annular, self-expanding transcatheter aortic valve replacement (TAVR) compared to surgery. The data were presented as a late-breaking clinical trial at the American College of Cardiology’s 71st Annual Scientific Session (ACC.22).

April 02, 2022
Japan Approves Shockwave's Intravascular Lithotripsy for Coronary Interventions
Shockwave Medical’s Intravascular Lithotripsy System
Dr. Shigeru Saito: "Given the safety profile shown to date across multiple studies and calcium morphologies, along with its ease-of-use, I am confident that coronary IVL will offer Japanese physicians a truly unique treatment option for our most challenging patients with calcified lesions.”


September 30, 2021
FDA Approval and First Implant of Orsiro Mission Drug-Eluting Stent System in the U.S.
Orsiro® Mission bioabsorbable polymer coronary drug-eluting stent
BIOTRONIK announced today it received U.S. Food and Drug Administration (FDA) approval of its Orsiro® Mission bioabsorbable polymer coronary drug-eluting stent system (BP-DES). The company also announced the first US implant and full commercial availability in the U.S.


September 28, 2021
Medtronic Receives CE Mark Approval for Radial Artery Access Portfolio
Medtronic's Rist Radial Access Catheter
Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received CE Mark approval for its radial artery access portfolio, which includes the Rist™ 079 Radial Access Guide Catheter and Rist™ Radial Access Selective Catheter. The Rist 079 Radial Access Guide Catheter is the first catheter specifically designed for the unique demands of accessing the neuro vasculature through the radial artery versus access through the transfemoral artery.

September 5, 2021
Emergency: Climate Crisis!
California Fires
The Lancet, along with over 220 medical journals, today posted an editorial about the largest, most serious, health threat known to us today. It's not heart disease or cancer or COVID-19. It's climate change! And it can't be cured by angioplasty or surgery or chemo. In the words of Dr. Tedros Adhanom Ghebreyesus, Director-General of WHO, "The COVID-19 pandemic will end, but there is no vaccine for the climate crisis."

August 24, 2021
Medtronic Announces FDA Approval of Next-Gen TAVR System for Treatment of Symptomatic Severe Aortic Stenosis
Medtronic's Evolut Transcatheter Aortic Valves
Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut™ FX TAVR system. Designed to enhance ease-of-use and provide greater precision and control throughout the procedure, the Evolut FX system maintains the industry-leading hemodynamic (blood flow) and durability benefits of the Evolut platform, while bringing product and procedure innovation for patients with symptomatic severe aortic stenosis

July 22, 2021
Philips Announces 1st Patient Enrollment in DEFINE GPS Global Multicenter Study to Assess Superiority of PCI Procedures Guided by Co-registered iFR and Interventional Angiography
Philips SyncVision
This global, multi-center, prospective, randomized controlled study will enroll up to 3,200 patient at 100 sites to answer the question: Does guidance by instantaneous wave-free ratio (iFR) measurements co-registered on the angiogram demonstrate superior outcomes and improve the cost-effectiveness of percutaneous coronary intervention (PCI) procedures to open blocked coronary arteries?

June 30, 2021
Abbott's XIENCE Stent Receives FDA Approval for Shortest Blood Thinner Course for High Bleeding Risk Patients
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Abbott (NYSE: ABT) today announced its XIENCE family of stents has received U.S. Food and Drug Administration (FDA) approval for one-month (as short as 28 days) DAPT labeling for high bleeding risk (HBR) patients in the U.S. In addition, XIENCE stents recently received CE Mark approval for DAPT as short as 28 days – giving XIENCE stents the shortest DAPT indication in the world.

June 18, 2021
Society for Vascular Medicine Elects Dr. Herb Aronow as New President
Dr. Herbert D. Aronow
"It is an honor to serve as SVM's next President and I look forward to working alongside the Board of Trustees and other Society leaders to advance the vascular medicine discipline and the care of vascular patients," Aronow said. "In collaboration with other vascular organizations, I plan to broaden our efforts around vascular education, research and quality."

June 11, 2021
CMS Grants Transitional Pass-Through (TPT) Payment for Shockwave’s Coronary IVL
Shockwave Medical’s Intravascular Lithotripsy System
Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the Centers for Medicare & Medicaid Services (CMS) granted approval for a Transitional Pass-Through (TPT) payment for Shockwave C2 Coronary IVL device, effective July 1, 2021. The TPT status provides incremental payment for Shockwave C2 devices used in the hospital outpatient settings.

May 31, 2021
Complete Two-Year Data Confirms That Medtronic's Evolut TAVR System Is Non-Inferior to Open Heart Surgery in Low Risk Patients
Medtronic's Evolut Transcatheter Aortic Valves
Confirming the preliminary data that was previously presented at the 2019 Scientific Session of the American College of Cardiology, the complete data from over 1,400 patients enrolled in the Evolut Low Risk Trial was presented (virtually) at this year's EuroPCR meeting by John K Forrest, MD, FACC, FSCAI. The result: the primary endpoint of all-cause mortality or disabling stroke at two years was 4.3% for TAVR versus 6.3% for surgery (p<0.0001 for non-inferiority).

May 3, 2021
Medtronic Announces CE Mark of Evolut™ PRO+ TAVI System for Treatment of Symptomatic Severe Aortic Stenosis Patients in Europe
Evolut™ PRO+ TAVI System
The system includes 4 valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest annular range (for self-expanding TAVI technology) on the market. The approval follows a recent indication expansion for the Evolut platform in Europe for patients with severe aortic stenosis who are at a low risk of surgical mortality and patients with bicuspid aortic valves who are at intermediate, high and extreme risk of surgical mortality.

April 27, 2021
CMS Proposes Additional Payment for Shockwave’s Coronary IVL in Hospital Inpatient Cases
Shockwave Medical’s Intravascular Lithotripsy System
Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the Centers for Medicare and Medicaid Services (CMS) published the Fiscal Year 2022 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule, which recommended that coronary IVL cases be eligible for incremental payment via a New Technology Add-On Payment (NTAP) from CMS when performed in the hospital inpatient setting.

April 6, 2021
Philips SmartCT 3D Image Acquisition, Visualization and Measurement Software for its Azurion Image Guided Therapy System Receives FDA 510(k) Clearance
Philips SmartCT
SmartCT is a key component of Philips Azurion Image Guided Therapy System, providing interventionalists with CT-like 3D images (Cone Beam CT) to support diagnosis, therapy planning, treatment and follow-up for interventional procedures. Bringing intuitive touchscreen control of advanced 3D image acquisition, visualization, vessel/organ segmentation, and quantitative measurements to the table-side, within the interventional lab’s sterile zone, SmartCT helps enhance clinical confidence, smooths workflows, and increases productivity.

March 26, 2021
Medtronic Receives FDA Approval for "Breakthrough" Transcatheter Pulmonary Valve Replacement for Patients with Congenital Heart Disease
Harmony™ Transcatheter Pulmonary Valve (TPV)
Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval for its Harmony™ Transcatheter Pulmonary Valve (TPV), the 1st minimally invasive therapy created to treat patients with a specific type of congenital heart defect of the right ventricle, one of the four chambers of the heart, which makes it difficult for blood to travel from the heart to the lungs.

February 16, 2021
Shockwave Intravascular Lithotripsy FDA Approved to Treat Advanced Heart Disease
Shockwave Medical’s Intravascular Lithotripsy System
Shockwave Medical, Inc. (NASDAQ: SWAV) announced today that the company’s sonic pressure wave therapy received Pre-Market Approval for severely calcified coronary artery disease from the U.S. Food and Drug Administration (FDA). This innovative technology, which was granted Breakthrough Device designation by the FDA, is a novel application of lithotripsy, an approach that has been used for decades to safely break up kidney stones. With this approval, IVL is now commercially available in the United States to treat problematic calcium in the coronary arteries, which can reduce blood flow in the heart.

January 16, 2021
Charles Dotter Invents Angioplasty
Dr. Charles Dotter
Angioplasty was born 57 years ago today when Dr. Charles T. Dotter, a radiologist in Portland, Oregon, performed the first angioplasty. But it wasn’t in the heart; it was in the leg. An 82-year-old woman was suffering from great pain in her left foot because of blocked circulation in her leg. Her toes had become gangrenous and there was an non-healing ulcer. Amputation was recommended by the physicians at Oregon Health Sciences University, but the woman refused.

October 15, 2020
DISRUPT CAD III Meets all Endpoints in U.S. Pivotal Study for Coronary Intravascular Lithotripsy
Shockwave IVL System
The Shockwave Coronary IntraVascular Lithotripsy (IVL) System has been available in Europe for more than 2 years, but to receive U.S. approval, it needed to show safety and efficacy in a trial specifically designed to meet FDA requirements. Today the 30-day results of the DISRUPT CAD III were presented by Dr. Dean Kereiakes at #TCTConnect, the online virtual version of the annual Transcatheter Cardiovascular Therapeutics meeting, & the device met all endpoints, moving it closer to approval for the U.S. market.

October 1, 2020

Medtronic Resolute Onyx™ Drug Eluting Stent (DES) First to Receive One-Month DAPT Labeling in the U.S. with Expanded Indication for High Bleeding Risk Patients
Medtronic's Resolute Onyx Drug-Eluting Stent
Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval for new one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx™ DES. The Resolute Onyx DES is the first-and-only DES in the U.S. that has been proven safe and effective utilizing a one-month regimen of DAPT – the combination of aspirin and an anti-clotting medication – following a percutaneous coronary intervention (PCI) in patients at high bleeding risk.

June 16, 2020
ABRE Study Meets Primary Safety and Effectiveness Endpoints
Medtronic's Abre Venous Stent
Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the first-ever results from the ABRE clinical study assessing the safety and effectiveness of the investigational Abre™ venous self-expanding stent system in subjects with iliofemoral venous outflow obstruction. The study met the primary safety and effectiveness endpoints, and the data were presented today virtually via the 2020 Charing Cross Symposium.

June 8, 2020
Shockwave Medical Announces That CMS Has Created New Codes for Intravascular Lithotripsy
Shockwave Medical’s Intravascular Lithotripsy System

Doug Godshall, President and CEO of Shockwave Medical: "The decision by CMS to assign codes for peripheral IVL procedures in both outpatient and inpatient settings is an important validation of Shockwave’s technology as a unique and distinct therapy for treating complex calcified disease in the peripheral arteries.... The appreciation for IVL’s unique ability to safely and effectively treat these challenging patients is growing globally and we are grateful that CMS has taken this important first step on the path towards establishing a reimbursement level that appropriately reflects the clinical value delivered by IVL."

June 5, 2020
Medtronic Resolute Onyx™ DES Receives First and Only One-Month DAPT Indication for High Bleeding Risk Patients in Europe
image
Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received CE (Conformité Européenne) Mark for a one-month dual antiplatelet therapy (DAPT) indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx™ Drug-Eluting Stent (DES). For HBR patients, whose bleeding risk may be increased by taking longer DAPT regimens (a combination of aspirin and anti-clotting medication), this new, first-of-its-kind indication allows physicians to recommend a shorter, one-month regimen of DAPT, following a percutaneous coronary intervention (PCI) with Resolute Onyx.

May 18, 2020
Jeffrey J. Popma, M.D. to Join Medtronic as Vice President and Chief Medical Officer for Coronary, Renal Denervation, and Structural Heart Businesses
Dr. Jeffrey J. Popma
Dr. Popma is an internationally renowned interventional cardiologist, who is an expert in transcatheter aortic valve replacement and transcatheter mitral and tricuspid valve therapies. He is past president of the Society of Cardiac Angiography and Interventions (SCAI) and served as chairman of the American College of Cardiology (ACC) Cardiac Catheterization Committee. Dr. Popma has directed numerous multi-center cardiovascular device clinical trials, including aortic valve prostheses, bare metal stents, drug-eluting stents, distal protection devices, total occlusion devices, and carotid and peripheral revascularization procedures.

April 8, 2020
Cardiac Arrest Deaths at Home in New York City Have Increased By a Startling 800%
Ambulance
There's been a 50% or more drop in the number of people receiving emergency treatment for heart attacks in many hospitals. Physicians have been speculating why this might be. Now frightening numbers from New York City's overwhelmed emergency medical system may provide part of the answer: hundreds of people a day have been dying of cardiac arrest in their homes, an eight-fold increase over the same period last year.

April 6, 2020
Doctors Say: Don't Sit Out a Heart Attack at Home
Twitter poll showing significant drop in patients presenting with heart attack symptoms (MI/ACS)
Since the onset of the novel coronavirus COVID-19, hospital emergency departments have seen a precipitous drop in the number of heart attack patients presenting for treatment. The big question is why? Are there really less heart attacks occurring, or are patients staying home, afraid to come to the hospital for fear of contracting the virus? There's good reason to believe that the latter may be the case, and the implications are extremely troubling.

April 6, 2020
Shockwave Completes Enrollment in Pivotal Study for Coronary Intravascular Lithotripsy
Shockwave Medical’s Intravascular Lithotripsy System
Shockwave Medical, Inc. (NASDAQ: SWAV) announced today that the company has completed enrollment in the pivotal U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study – DISRUPT CAD III – for the use of IVL in heavily calcified coronary arteries. The investigational Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter, which has been granted Breakthrough Device Designation by the FDA, is an innovative therapy designed to fracture problematic calcium using sonic pressure waves in order to facilitate stent delivery, deployment and optimal expansion.

March 22, 2020
Philips Ramps Up Production of Critical Health Technology Products in Response to COVID-19 Pandemic
Philips Respironics Ventilator
Philips is ramping up the production of hospital ventilators and plans to double production within the next eight weeks and achieve a four-fold increase by the third quarter of 2020. The company is mobilizing its global supplier network to step up support and production in this extraordinary situation. Philips has a global manufacturing footprint with final assembly sites in North America, Europe and Asia, and, equally important, a global network of certified materials and component suppliers.

March 19, 2020
Medtronic Has Ramped Up Ventilator Production
Puritan Bennett™ 980 ventilator by Medtronic
Medtronic, manufacturer of the Puritan Bennett line of ventilators, reports that they have already increased their production by 40% and are "on track" to achieve twice their normal output. Manufactured in Galway, Ireland, Medtronic's workforce numbers 250. The company is doubling that, bringing in new people and transferring staff from other Medtronic sites, and reconfiguring its plant to operate 24/7.

February 4, 2020
Medtronic Begins New Pilot Study as Part of SPYRAL HTN Clinical Program for Renal Denervation in Hypertension Patients
Symplicity™ Spyral renal denervation (RDN) system
Medtronic plc (NYSE:MDT) today announced it will begin enrollment in a pilot study evaluating the safety and efficacy of the Symplicity™ Spyral renal denervation (RDN) system using a targeted procedural approach with a reduced number of radio frequency (RF) ablations. Set to enroll 50 patients at up to 15 sites in the U.S. and Europe, the single-arm study is designed to focus on ablating the distal main renal artery and primary branches to lower blood pressure utilizing a simplified procedural approach.

September 23, 2019
Interview with Dr. Tejas Patel and Dr. Samir Pancholy
Dr. Tejas Patel performing world's 1st telerobotic PCI
In December 2018, Dr. Tejas Patel performed the world's first telerobotic coronary angioplasty. Stationed 32km from the hospital and the patients, he did five PCI procedures, all successful. In this interview Dr. Patel and his colleague, Dr. Samir Pancholy, discuss telerobotic PCI.


September 23, 2019
Medtronic Announces FDA Approval and U.S. Launch of Next-Generation Evolut™ PRO+ TAVR System for Treatment of Symptomatic Severe Aortic Stenosis Patients
Medtronic's Evolut PRO+
The Evolut PRO+ TAVR System includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest indicated patient treatment range and the lowest delivery profile currently on the market. The launch comes on the heels of the FDA’s recent indication expansion for the Evolut TAVR platform to treat patients with symptomatic severe aortic stenosis at a low risk of surgical mortality, the final surgical risk category to be approved for TAVR.

September 7, 2019
IN.PACT AV Access Trial Meets Primary Safety and Effectiveness Endpoints
IN.PACT™ AV™ drug-coated balloon (DCB)
Medtronic plc (NYSE:MDT) announced the first-ever results from the IN.PACT AV Access clinical study comparing the investigational IN.PACT™ AV™ drug-coated balloon (DCB) to percutaneous transluminal angioplasty (PTA) in patients with de novo or non-stented restenotic arteriovenous (AV) fistulae lesions. The study met primary safety and effectiveness endpoints and data were presented today at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting in Barcelona, Spain.

September 3, 2019
FDA Fast Tracks Shockwave IVL Device Review
Shockwave Medical’s Intravascular Lithotripsy System
Shockwave's unique coronary calcium modification system has received the U.S. Food and Drug Administration's "Breakthrough Device Designation," meaning that when the device comes before the agency for approval, it will receive a priority review, potentially speeding its availability to the interventional cardiology in the U.S.


August 16, 2019
Medtronic Evolut TAVR System Receives Expanded Indication to Treat Symptomatic Severe Aortic Stenosis Patients at Low Risk for Surgical Mortality
Medtronic's CoreValve Evolut
Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval of the Evolut™ Transcatheter Aortic Valve Replacement (TAVR) system for patients with symptomatic severe native aortic stenosis who are at a low risk of surgical mortality. The low-risk patient population is the final surgical risk category to be approved for this minimally invasive alternative to open-heart surgical valve replacement (SAVR) and includes patients who may be younger and more active than higher-risk patients.

August 16, 2019
Edwards SAPIEN 3 TAVR Receives FDA Approval For Low-Risk Patients
Edwards SAPIEN 3 valve
Edwards Lifesciences Corporation (NYSE: EW) today announced U.S. Food and Drug Administration (FDA) approval to expand use of the Edwards SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems to the treatment of severe, symptomatic aortic stenosis (AS) patients who are determined to be at low risk of open-heart surgery.


August 8, 2019
Corindus Vascular Robotics Announces Definitive Agreement to be Acquired by Siemens Healthineers
Interventional cardiologist at CorPath GRX console
Mark J. Toland, President and Chief Executive Officer of Corindus stated, "“We are pleased to have reached this agreement with Siemens Healthineers.... The combination of Siemens Healthineers’ advanced, high-quality imaging, digital and artificial intelligence tools with Corindus’ precision robotics platform has the potential to transform the way healthcare is delivered to those suffering from cardiovascular or peripheral disease. The tremendous technology synergies and shared vision between both companies should allow us to achieve a seamless integration between our businesses."

July 25, 2019
Interview with Dr. Hirotoshi Watanabe on the STOPDAPT-2 Study
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The STOPDAPT-2 study demonstrated that 1 month of DAPT followed by clopidogrel monotherapy, compared with 12 months of DAPT with aspirin and clopidogrel, resulted in a significantly lower rate of a composite of cardiovascular and bleeding events, meeting criteria for both noninferiority and superiority. Angioplasty.Org’s partner site, TCROSS NEWS, recently interviewed Dr. Watanabe, a principal author of the present study, regarding the background and important findings of the study.

April 24, 2019
Bringing Japanese Know-How to the Global Market: A Visit to Shimadzu Medical Systems
Shimadzu Trinias Angiography System
TCROSS NEWS and its global partner, Angioplasty.Org, visited Shimadzu Corporation, a major Japanese company founded in 1875, to learn about its plans for future overseas business development of its angiography systems. We saw demonstrations of the Trinias Angiography System, the SCORE StentView software and more.


February 26, 2019
FDA Approves Medtronic's Resolute Drug-Eluting Stent Platform for Treatment of Chronic Total Occlusions
Medtronic's Resolute Onyx Drug-Eluting Stent
The FDA today approved an expanded indication for Medtronic's family of Resolute zotarolimus-eluting coronary stents: use in the treatment of de novo chronic total occlusions (CTO). This approval includes all Resolute DES devices, including the Resolute Onyx™ and Resolute Integrity™ DES.


January 30, 2019
Medtronic Valiant™ Captivia™ Demonstrates Durability, Safety, and Efficacy at Five Years in Transection Patients
Valiant™ Captivia™ Thoracic Stent Graft
Medtronic plc (NYSE:MDT) announced new data supporting the long-term durability, safety, and efficacy of the Valiant™ Captivia™ thoracic stent graft system for the treatment of blunt thoracic aortic injury (BTAI). The presentation by Himanshu J. Patel, M.D., University of Michigan Department of Cardiac Surgery at The Society of Thoracic Surgeons Annual Meeting, was the first and only five-year industry-issued dataset ever reported for patients with aortic transections undergoing thoracic endovascular aortic repair (TEVAR).

January 17, 2019

Philips Launches Azurion with FlexArm to Set New Standard for the Future of Image-Guided Procedures
Azurion with FlexArm
During increasingly complex interventions, clinicians need to quickly and easily visualize critical anatomy and identify changes to the patient during the procedure. Azurion with FlexArm includes a set of innovations that makes it easier for the clinician to perform imaging across the whole patient in both 2D and 3D. As the clinician moves the system, the image beam automatically maintains alignment with the patient, allowing more consistent visualization and enabling them to keep their focus on the treatment.

January 15, 2019
Medtronic Launches Mobile App That Communicates Directly with World's First Smartphone-Connected Pacemakers
MyCareLink Heart™
mobile app
Compatible with Medtronic BlueSync™ technology-enabled pacemakers, the MyCareLink Heart mobile app is designed to securely and wirelessly send device data to the Medtronic CareLink™ network via smart technology, eliminating the need for a dedicated bedside monitor or other remote monitoring hardware.


December 11, 2018
Shockwave Announces Collaboration with Abiomed on Physician Training
Shockwave Medical’s Intravascular Lithotripsy System
Shockwave Medical today announced an investment and collaboration agreement with Abiomed, Inc. As outlined by the agreement, Abiomed will invest $15 million in Shockwave and the two companies will collaborate on a training and education program in the United States and Germany focused on the benefits of complementary use of their respective technologies.

December 6, 2018
Corindus’ Technology Successfully Used in World’s First-in-Human Telerobotic Coronary Intervention
Dr. Tejas Patel performing world's 1st telerobotic PCI
Corindus Vascular Robotics, Inc. [NYSE American: CVRS] announces that its CorPath technology was used to conduct the first-in-human (FIH) Telerobotic Intervention Study, December 4 and 5, 2018, in India. This study represents the world’s first percutaneous coronary intervention (PCI) conducted from a remote location outside of the catherization lab. Five patients located at the Apex Heart Institute in Ahmedabad, Gujarat, underwent an elective PCI procedure from a distance of roughly 20 miles (32 km) away.

November 13, 2018
Medtronic's Valiant Navion Thoracic Stent Graft System Garners Both FDA and CE Mark Approvals
Valiant Navion Thoracic Stent Graft System
Only three weeks ago, Medtronic's Valiant Navion™ Thoracic Stent Graft System received FDA approval. Today, the company announced that its low profile device now has been approved for the CE Mark in Europe as well. According to Medtronic, this lower profile stent graft, which was eight years in the making, now makes it possible to use as a treatment in the broadest possible patient population, especially in those whose anatomy would not permit thoracic endovascular aneurysm repair (TEVAR), such as patients with narrower or more curved iliac arteries, most commonly female.

November 12, 2018
5-Year Data for IN.PACT Drug-Coated Balloon in SFA Show Improved Outcomes Over Standard PTA
IN.PACT Admiral Drug Coated Balloon (DCB)
At last week's Vascular Interventional Advances (VIVA) Annual Meeting in Las Vegas, Medtronic presented five-year final outcomes from its IN.PACT SFA Trial. Of note: Medtronic is the first company to present long-term five-year outcomes for a commercially-available drug-coated balloon (DCB). The data not only reinforced the safety, durability, and efficacy of the IN.PACT Admiral DCB, as seen in previous studies, but also reaffirmed its use as a frontline therapy for the treatment of peripheral artery disease (PAD).

October 23, 2018
Medtronic Receives FDA Approval for Valiant Navion™ Thoracic Stent Graft System
Valiant Navion Thoracic Stent Graft System
Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval for the Valiant Navion™ thoracic stent graft system for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), blunt thoracic aortic injuries (BTAI), penetrating atherosclerotic ulcers (PAU), intramural hematomas (IMH), and aortic type B dissections (TBAD).

October 8, 2018
Drug-Eluting Stent Expansion Chart
stent expansion chart
A useful chart for the cath lab wall, this chart, created by Dr. Ajay Kirtane and the teams at NY Presbyterian/University of Columbia Medical Center, shows the nominal and post-dilatation expansion limits for four widely-used drug-eluting stents: Synergy (Boston Scientific), Resolute Onyx (Medtronic), Xience Sierra (Abbott Vascular), and EluNIR (Medinol/Cordis).

October 2, 2018
New Data for IN.PACT Drug-Coated Balloon Show Sizable Advantage Over Standard PTA in Peripherals
IN.PACT Admiral DCB
Dual presentations, made a little over a week ago at the Transcatheter Cardiovascular Therapeutics (TCT) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual meetings in San Diego and Lisbon, showed significant superiority of Medtronic's IN.PACT Admiral drug-coated balloon (DCB) over standard Percutaneous Transluminal Angioplasty (PTA)

September 24, 2018

Medtronic Builds on TAVR Clinical Evidence Portfolio with Five-Year CoreValve Durability Data and Complete Two-Year Outcomes in Intermediate Risk Aortic Stenosis Patients
Medtronic's CoreValve Evolut
Medtronic (NYSE:MDT) announced new data presented at the 30th TCT conference in San Diego. Investigators presented the longest-term data to-date from the CoreValve U.S. Pivotal Trial, in addition to the complete two-year outcomes from the SURTAVI trial, which confirmed the excellent outcomes previously predicted in aortic stenosis patients at intermediate surgical risk.

August 15, 2018
Medtronic Announces Commercial Launch of the IN.PACT™ Admiral™ Drug-Coated Balloon in Japan
IN.PACT™ Admiral™ Drug-Coated Balloon
Medtronic plc (NYSE:MDT) today announced full commercial launch of the IN.PACT™ Admiral™ Drug-Coated Balloon (DCB) in Japan. The news follows the completion of a post-market clinical trial, which enrolled 300 subjects. IN.PACT Admiral received approval last year from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the treatment of peripheral artery disease (PAD) in the upper leg - specifically, in the thigh (superficial femoral arteries (SFA)) and behind the knee (popliteal arteries). The MHLW also granted reimbursement approval for the IN.PACT Admiral in December of 2017.

June 23, 2018
FDA OKs IN.PACT™ Admiral™ Drug Coated Balloons of 200mm and 250mm Lengths
IN.PACT™ Admiral™ Drug-Coated Balloon
A subset of Medtronic's IN.PACT Global Study analyzed very long lesions in the SFA of over 180mm (7 inches), including cases of in-stent restenosis (ISR) and chronic total occlusions (CTO). The one-year results showed patency of 89.1% and clinically-driven target lesion revascularization at 7.1%. As a result of these findings, in April the FDA approved the IN.PACT DCB for treatment of long lesions. And last week, the FDA approved two new long length IN.PACT balloons (200mm and 250mm) that will become an important part of the armamentarium, implementing the April long lesion approval.

May 23, 2018
Newest Generation of Leading Heart Stent is Now Approved in the U.S. for People with Coronary Artery Disease
Xience Sierra Everolimus-Eluting Stent
Abbott (NYSE: ABT) today announced it received approval from the U.S. Food and Drug Administration (FDA) for XIENCE Sierra™, the newest generation of the company's gold-standard XIENCE everolimus-eluting coronary stent system. XIENCE stents are among the world's most-used and studied stents and have an exceptional safety record with low rates of complications. Design and technology advances in this generation of XIENCE include features specifically designed for the treatment of complex blockages that now account for up to 70 percent of cases.

May 21, 2018

Shockwave Launches Coronary Intravascular Lithotripsy in Europe
Shockwave Medical’s Intravascular Lithotripsy System
Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, today announced the European commercial availability of Intravascular Lithotripsy (IVL) for calcified coronary artery disease (CAD), as well as the enrollment of the first patient in the DISRUPT CAD II post-market study by Professor Jonathan Hill, MD, at King’s College in London.

May 24, 2018
Signal of Early Healing of Drug-Eluting Stent Seen in Resolute Onyx 1-Month OCT Study
image
To test how completely and quickly an artery implanted with a Resolute Onyx healed, a small group of 15 patients had OCT imaging performed at one month (13 of them diagnosed with acute coronary syndrome or ACS). The results were presented this week at the annual EuroPCR meeting in Paris. At only one month, an average of 88% of the struts were covered by neointimal formation (new cell growth over the struts) with 92.3% of the total stented area showing complete coverage.

April 23, 2018
Medtronic IN.PACT™ Admiral™ Drug Coated Balloon Receives FDA Approval to Treat Long SFA Lesions
IN.PACT™ Admiral™ Drug-Coated Balloon
Medtronic plc (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT™ Admiral™ Drug-Coated Balloon (DCB) to treat long superficial femoral artery (SFA) lesions up to 360mm in patients with peripheral artery disease (PAD). Approval was based on clinical data from the complex lesion imaging cohorts of the IN.PACT Global Study, showing a one-year patency rate of 89.1% and a clinically-driven target revascularization (CD-TLR) rate of 7.1%.

April 5, 2018
Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics
image
Medtronic plc (NYSE: MDT) today announced Laura Mauri, M.D., M.Sc., interventional cardiologist and clinical researcher at the Brigham and Women's Hospital, and professor of medicine at Harvard Medical School, will join Medtronic as Vice President, Global Clinical Research & Analytics. Dr. Mauri will direct the company's dynamic global clinical research strategies which leverage her widely recognized clinical trial leadership and deep domain expertise in medical technology evaluation and clinical research methodology.

February 26, 2018
Medtronic's Resolute Onyx Stent Now Available in Diameters from 2.0-5.0mm
Medtronic Resolute Onyx
Based primarily on the results of the RESOLUTE ONYX 2.0 mm Clinical Study, first presented at the EuroPCR meeting in May 2017, the U.S. FDA has approved Medtronic's Resolute Onyx™ 2.0mm zotarolimus-eluting stent, making it the smallest diameter DES on the market. The news, announced today by Medtronic plc (NYSE: MDT) means that the Resolute Onyx line is now available in the widest range of any coronary stent, from 2.0mm to 5.0mm

January 30, 2018
IN.PACT Admiral Demonstrates Consistent and Durable Outcomes in New Two-Year Japan Data and IN.PACT Global Critical Limb Ischemia Cohort Analysis
IN.PACT Admiral DCB
The new data presented at the Leipzig Interventional Course (LINC) in Leipzig, Germany, included the two-year results from the MDT-2113 study (IN.PACT SFA Japan) and data from a critical limb ischemia (CLI) subgroup analysis from the IN.PACT Global Study.

 

January 26, 2018
Medtronic Launches IDE Study to Evaluate the Abre™ Venous Self-Expanding Stent System in Patients with Deep Venous Disease
Dr. Erin Murphy

The multi-center, single arm study intends to enroll 200 subjects with deep venous disease. The primary efficacy endpoint will evaluate patency at 12 months and the primary safety endpoint will evaluate the incidence of composite Major Adverse Events (MAE) at 30 days following stenting of an obstruction in the iliofemoral venous segment. Data from the study will be used to support the Abre stent U.S. pre-market approval (PMA) application for the treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease.


January 24, 2018
Medtronic Launches ENCHANT Study to Evaluate ChEVAR Parallel Graft Technique with the Endurant™ II/IIs Stent Graft System
Endurant IIs Stent Graft
A ChEVAR procedure refers to the use of a parallel graft chimney technique that uses covered renal stents with a standard aortic stent graft. The study is the first to assess the clinical outcomes, safety, and performance of the ChEVAR technique for treating patients with complex aneurysms with short infrarenal neck lengths of >2 mm in a real-world setting with the Endurant™ II/IIs Stent Graft System.

January 10, 2018
3-Year Outcomes of Surgical vs. Endovascular Revascularization for Critical Limb Ischemia
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Dr. Osama Iida discusses the SPINACH Study, recently published in Circulation: Cardiovascular Interventions. This registry randomized 548 patients and, while showing no significant differences in the endpoint, the study did indicate that certain patient populations do better with one or the other of these revascularization strategies. (Posted in collaboration with TCROSS NEWS)

January 8, 2018
Study: Similar Outcomes for 6 vs. 12 Months of DAPT for STEMI Patients Treated with Medtronic's Resolute Integrity Drug-Eluting Stent
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One year is the recommended DAPT duration for STEMI patients after stenting. But this new study shows that 6 months may be adequate with certain devices: important data, especially for patient at high risk for bleeding.


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