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June 30, 2021
Abbott's XIENCE Stent Receives FDA Approval for Shortest Blood Thinner Course for High Bleeding Risk Patients
image
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
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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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