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July 10, 2017
FDA Gives Approval to Medtronic's CoreValve for Use in Patients at Intermediate Risk for Surgical Valve Replacement
3 generations of CoreValve
Based on results from the landmark SURTAVI Clinical Trial, presented at the American College of Cardiology Annual Meeting in March, and published in the New England Journal of Medicine, the FDA has approved the CoreValve TAVR self-expanding platform for use in patients with severe and symptomatic aortic stenosis who are at "intermediate" risk for surgical valve replacement, defined as mortality >= 3% at 30 days.

June 30, 2017
Barriers to Achieving Optimal Door-to-Balloon Time in Japan: Interview with Dr. Shun Kohsaka
image
In this interview, co-author Dr.Shun Kohsaka of the Department of Cardiology at Keio University School of Medicine in Tokyo, Japan, discusses a study, recently published in the Japanese Circulation Society's Circulation Journal, demonstrating that door-ro-balloon time in half of STEMI cases in Japan is greater than 90 minutes.(Posted in collaboration with TCROSS NEWS.)

June 19, 2017
Interview with Dr. Osamu Iida
Osamu Iida, MD
Dr. Iida was principal investigator for the PRIORITY registry, testing whether revascularization impacted survival at one-year for poor-risk-CLI patients. The study was published in the June 12 issue of JACC: Cardiovascular Interventions and looked at over 600 patients in 37 hospitals across Japan. (Posted in collaboration with TCROSS NEWS.)


April 6, 2017
History, Gruentzig, and Abbott’s Absorb “Dissolving Stent”
Gruentzig holding his PTCA balloon
There’s a lesson for the Absorb BVS in the history of interventional cardiology (an area of particular interest in this 40th anniversary of angioplasty year). Andreas Gruentzig, the inventor of coronary angioplasty had very specific requirements of physicians who were going to start using his balloons, and he also resisted the urge to over-publicize.


April 6, 2017
Status of the “Disappearing Stent” in Europe: It’s Complicated!
Abbott's Absorb BVS
An updated version of our article on Abbott’s Absorb BVS (Bioresorbable Vascular Scaffold) in the European markets. A letter, which just began circulating on Twitter last evening, was actually sent to Abbott’s customers in Europe a week ago. The letter states: “Effective May 31, 2017, the device will only be available in clinical register setting at select sites/institutions that will play a pivotal role in the monitoring of this technology until Summer 2018 at which time the situation will be reviewed.”

March 22, 2017
Medtronic Receives FDA Approval for CoreValve™ Evolut™ Pro Transcatheter Valve with Advanced Sealing
Medtronic CoreValve Evolut PRO
Medtronic plc (NYSE:MDT) today announced FDA approval and U.S. launch of the CoreValve™ Evolut™ PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. The approval comes on the heels of new 30-day clinical data that was unveiled at the American College of Cardiology (ACC) 66th Annual Scientific Session, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics for the self-expanding valve.

March 21, 2017
First U.S. Case Done with Tryton's Side Branch Stent
Tryton's Side Branch Stent
Earlier this month, the FDA approved Tryton Medical's Side Branch Stent and today, at New York-Presbyterian Hospital/Columbia University Medical Center in New York, the first case was performed by two of the leading interventional cardiologists in the U.S., Dr. Martin Leon and Dr. Ajay Kirtane.


March 16, 2017
Interventional Cardiology Late-Breakers at ACC.17
Washington Convention Center
Over the next three days, a voluminous amount of data will be presented, shared, and debated among an estimated 18,000 attendees of the annual meeting of the American College of Cardiology, this year held in Washington, DC. While the meeting covers the whole spectrum of cardiology and heart-related issues, there are a number of studies and late breaking clinical trials specific to the subspecialty of interventional cardiology.

March 10, 2017
Medtronic's Micra Leadless Pacemaker Approved for Reimbursement in U.S.
Micra® Transcatheter Pacing System
In a big leap forward for the use of leadless pacemakers, U.S. Centers for Medicare & Medicaid Services (CMS) today approved reimbursement coverage for Medtronic's Micra® Transcatheter Pacing System (TPS), the only FDA-approved leadless pacing system. A major advantage of leadless pacemakers is that they can be implanted via catheter, in a similar fashion to angioplasty, so no surgical incision or pocket is necessary.

March 9, 2017
Medtronic Launches Below-The-Knee Clinical Study in Europe for Treatment of PAD Using New Drug-Coated Balloon Technology
IN.PACT™ Admiral™ drug-coated balloon (DCB)
This study will evaluate the IN.PACT 0.014 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter. This is an investigational device, which uses Medtronic's unique IN.PACT™ Admiral™ drug coating technology. The study will enroll approximately 60 patients at four sites in Europe. The primary endpoint is late lumen loss at nine months.

February 27, 2017
New Analysis of Reverse Trial Shows Medtronic CRT Devices Cost-Effective, While Helping Patients with Mild Heart Failure Live Longer
Viva Quad XT CRT, one of Medtronic's CRT-D devices
Medtronic plc (NYSE:MDT) today announced an economic analysis of five-year data showing that patients with mild heart failure who get cardiac resynchronization therapy (CRT) devices early in their treatment live longer and that implanting these devices is cost-effective, compared to optimal medical therapy.


February 21, 2017
Interview with Dr. Yutaka Tanaka
Yutaka Tanaka, MD, PhD
Dr. Yutaka Tanaka discusses his group's study on transradial coronary interventions for complex chronic total occlusion, just published in JACC: Cardiovascular Interventions. The patient population for this single-center study comprised almost 600 patients and looked at whether the transradial approach was feasible for complex chronic total occlusions. The center, Shonan Kamakura General Hospital, performs 80% of its procedures via the wrist and is home to world renowned experts in the treatment of CTOs. (Posted in collaboration with TCROSS NEWS.)

February 13, 2017
Medtronic Goes Radial
Medtronic's TRAcelet™ compression device for transradial hemostasis
This morning Medtronic plc (NYSE: MDT) announced that it is now offering a full portfolio of transradial-specific tools: a line of catheters, a TRA access kit with introducer sheath, and its TRAcelet™ compression device for simplifying patent hemostasis post-procedure. Although the company previously has marketed a select number of items designed for the transradial approach (TRA), today's announcement marks the first full-transradial offering by a major stent manufacturer in the United States and has the potential to further accelerate the adoption of this approach among interventional cardiologists.

February 9, 2017
First Drug-Coated Balloon (DCB) Study Results in Japan Demonstrate Consistent Clinical Outcomes with Other Medtronic DCB Studies
IN.PACT drug-coated balloon superimposed on map of Japan
The IN.PACT SFA Japan Trial enrolled 100 patients at 11 sites in Japan who were randomized to treatment with either the DCB (n=68) or plain balloon angioplasty (percutaneous transluminal angioplasty, or PTA) (n=32). Per protocol, primary patency rates were assessed at 12 months of follow-up and demonstrated: 89.2 percent for the DCB group and 48.4 percent for the PTA group (p<0.001).

February 1, 2017
Medtronic CardioInsight Mapping Solution Cleared by FDA
CardioInsight™ Noninvasive 3D Mapping System
Cardiac mapping - typically accomplished by inserting a catheter into the heart via an artery or vein - allows physicians to locate the origin of a patient's irregular heart rhythms (arrhythmias). In contrast, the CardioInsight system is the first commercially released, noninvasive, cardiac electrical mapping system in the world, eliminating the invasive steps of this clinical procedure.

January 24, 2017
Medtronic Announces CE Mark for New Lower Profile HawkOne 6F Directional Atherectomy System
HawkOne Directional Atherectomy System
The HawkOne system is designed to remove plaque from the vessel wall and restore blood flow. The new HawkOne 6 French (6F) provides an effective and easy-to-use treatment option for patients with PAD both above and below the knee with a single device at a lower profile.


January 17, 2017
Medtronic Announces CE Mark and European Launch of Recaptureable TAVI System Now Available for Severe Aortic Stenosis Patients with Large Anatomies
CoreValve™ Evolut™ R
34 mm valve
The new Evolut R 34 mm valve is approved for severe aortic stenosis patients who are at intermediate, high or extreme risk for surgery with an annulus size ranging from 26-30 mm. This large valve segment is estimated to account for approximately 20-25 percent of the eligible European TAVI patient population. Previously, some of these patients were unable to receive a TAVI due to the larger size of their native diseased aortic valve.

January 2, 2017
Abbott's Acquisition of St. Jude to Close This Week
St. Jude and Abbott logos
As of Wednesday, January 4, St. Jude Medical will no longer exist as a company; instead it will become part of Abbott, according to the press release below. This $25 billion deal is one of the largest recent mergers of medical device companies since Medtronic's 2015 acquisition of Covidien.


December 8, 2016
Interview with Dr. Masanori Yamamoto
Dr. Masanori Yamamoto
Dr. Masanori Yamamoto discusses the clinical and market impact in Japan of two new generation transcatheter aortic valves (TAVR): last week's approval of Medtronic's CoreValve Evolut R and Edwards' Sapien 3, which was approved earlier this year. (Posted in collaboration with TCROSS NEWS.)


December 6, 2016
Medtronic's Endurant™ II/IIs Stent Graft System Receives CE Mark for Use with ChEVAR Parallel Graft Technique
Endurant IIs Stent Graft
Medtronic plc (NYSE:MDT) today announced that it has received CE (Conformité Européenne) Mark for the Endurant™ II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients using a ChEVAR procedure, a parallel graft chimney technique that uses commercially available balloon expandable covered stents combined with a standard aortic stent graft. This expanded indication in the European Union enables the Endurant II/IIs stent graft system to be used in patients with complex aneurysms with short aortic neck lengths >2 mm, expanded from the prior neck length indication >10 mm.

December 5, 2016
Japan Announces Regulatory Process and Post Marketing Surveillance Policy for Abbott's Bioabsorbable Vascular Scaffolding
Abbott Absorb BVS and map of Japan
Last week Dr. Takashi Ouchi, a reviewer for the Office of Medical Devices III of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), announced the regulatory process and post marketing surveillance (PMS) policy that will be in effect for the Abbott Absorb bioabsorbable vascular scaffold (BVS). (This article was provided to Angioplasty.Org by its Japanese partner, TCROSS NEWS)

December 1, 2016
Medtronic Announces Reimbursement Approval and Launch of CoreValve™ Evolut™ R System in Japan
Medtronic CoreValve
Medtronic plc (NYSE: MDT) today announced it has received reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the recapturable, self-expanding transcatheter CoreValve™ Evolut™ R System for patients with severe aortic stenosis (AS) unable to undergo surgery, and for whom treatment with transcatheter aortic valve implantation (TAVI) is determined to be the best option. This approval follows the Shonin approval from the MHLW the company received in November.

November 15, 2016

Medtronic's Endurant™ II/IIs Stent Graft System Delivers Positive Outcomes in Patients with Challenging Aortic Aneurysms
Endurant Stent Graft
Medtronic plc (NYSE:MDT) today announced data supporting the strength and durability of the Endurant™ II/IIs1 stent graft system to treat abdominal aortic aneurysm (AAA) patients. The results, presented during the 43rd Annual Symposium of Vascular and Endovascular Issues (VEITHsymposium) in New York, are based upon new sub-analyses of Medtronic's ENGAGE Global Registry, which has enrolled more than 1,200 patients at 79 sites across six continents.

November 7, 2016
Abbott's Absorb™ Bioresorbable Stent Approved as the First Fully Dissolving Heart Stent in Japan
Abbott Absorb 'disappearing stent' approved in Japan
Abbott (NYSE: ABT) announced today that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the company's Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people in Japan with coronary artery disease. Absorb is the only fully dissolving heart stent approved in Japan for the treatment of heart disease, one of the leading causes of death in Japan and worldwide.

November 4, 2016
Interview with Dr. Hiroki Shiomi
Dr. Hiroki Shiomi
Dr. Hiroki Shiomi discusses the ReACT study from Japan which he presented at TCT2016. This study randomized 700 patients to either routine angiographic follow-up post-PCI or to clinical follow-up only to see if there was any additional benefit to angiography which is practiced in 80% of patients in Japan. (Posted in collaboration with TCROSS NEWS.)

November 1, 2016
Medtronic Harmony™ Transcatheter Pulmonary Valve Demonstrates Positive Early Clinical Outcomes at One Year
Harmony™ Transcatheter Pulmonary Valve
Presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, the positive new data from the first-of-its-kind early feasibility study led the U.S. Food and Drug Administration (FDA) to also recently approve the initiation of a Pivotal Investigational Device Exemption (IDE) study to evaluate the valve's safety and effectiveness.

November 1, 2016
Medtronic CoreValve™ Evolut R™ System Shows Exceptional Clinical Outcomes at One Year
CoreValve
Presented at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting, data from the study showed that 241 patients deemed extreme and high risk with symptomatic severe aortic stenosis had high rates of survival (91.4%) and low rates of disabling stroke (5.1%) at one year. Additionally, initial use of the larger, first-of-its-kind Evolut R 34 mm valve resulted in no deaths, no strokes, no vascular complications and two pacemaker implants (13.3%) at 30 days.

October 31, 2016
First Clinical Data of Medtronic Drug-Filled Stent Show Positive Outcomes
Laser-drilled abluminal holes in Medtronic's Drug-Filled Stent
The RevElution trial enrolled 101 patients at 14 centers in three countries in two different cohorts measuring outcomes at nine months and 24 months. In the first 50 patients included in the nine-month primary endpoint cohort, the DFS had in-stent late lumen loss of 0.26mm, which was non-inferior to the historical control (p<0.001). In addition, the DFS demonstrated low rates of target lesion failure (2.1%) and zero stent thrombosis at nine months.

October 31, 2016
New Data on Medtronic Evolut™ R TAVR System Show Excellent 'Real-World' Outcomes in Global Patient Population
Medtronic CoreValve Evolut™ R
Positive early clinical results from the first 300 patients enrolled in the FORWARD study -- a global, single-arm, prospective study at 60 centers across Europe, Australia, the Middle East, Africa, Latin America and Canada -- marks the first time that the self-expanding Evolut R System was evaluated in routine clinical practice on a global scale. The device demonstrated an exceptionally high survival (98%) and a low rate of all stroke (3%) at 30-days post-implant.

October 30, 2016
Independent Study Finds Biodegradable Polymer Stents Provide No Clinical Benefit Over Resolute Integrity™ DES
Professor Clemens von Birgelen
In the BIO-RESORT study, the primary composite endpoint of target vessel failure at one-year showed no statistically significant difference in outcomes for the Resolute Integrity DP-DES treated group (N=1173) at 5.4% compared to 4.7% with the Synergy BP-DES (N=1172) arm and 4.7% with the Orsiro (N=1169) BP-DES am (difference of 0.7%; p=0.45 for Synergy and p=0.46 for Orsiro). The one year outcomes also found no statistically significant difference in stent thrombosis between Resolute Integrity and the BP-DES groups (difference of 0.1%; p=0.77).

October 26, 2016
Medtronic Announces FDA Approval of New Recaptureable TAVR System Available for Severe Aortic Stenosis Patients with Large Anatomies
CoreValve (artist rendition)
Medtronic plc (NYSE:MDT) today announced FDA approval and U.S. launch of the CoreValve™ Evolut™ R 34mm valve-the largest sized transcatheter aortic valve replacement (TAVR) system available in the U.S. The new Evolut R 34mm valve is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30 mm. This large valve segment is estimated to account for approximately 25-30% of the eligible global TAVR patient population.

October 24, 2016
Medtronic Receives FDA Clearance of New Lower Profile HawkOne 6F Directional Atherectomy System
HawkOne Directional Atherectomy System
The HawkOne system is designed to remove plaque from the vessel wall and restore blood flow. The new HawkOne 6 French (6F) provides an effective and easy-to-use treatment option for patients with PAD both above and below the knee with a single device at a lower profile.


October 13, 2016
Medtronic Cardiac Devices Gain FDA Approval to Enable Patient Access to the Most Advanced Diagnostic Imaging
MRI machine
Medtronic plc (NYSE:MDT) is the first company to receive U.S. Food and Drug Administration (FDA) approval for its suite of cardiac rhythm and heart failure devices and leads to be scanned in both 3 and 1.5 Tesla (T) magnetic resonance imaging (MRI) machines. This advancement gives patients with Medtronic SureScan® MR-conditional pacemakers, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) and leads access to MRI scans on any part of the body.

September 20, 2016
Medtronic Valiant Captivia Demonstrates Safety and Efficacy at Three Years
Valiant® Captivia® Thoracic Stent Graft System
The FDA-approved Valiant Captivia System demonstrated continued safety and efficacy at three years. The data were gathered on 50 patients in the Medtronic Valiant Captivia Dissection IDE Trial, conducted at 16 U.S. sites. Highlights: freedom from all-cause mortality was 79.4%; freedom from dissection-related mortality was 90.0%; no post-index procedure ruptures or conversions; true-lumen diameter over the stented region remained stable or increased in 92.3%; false-lumen diameter remained stable or decreased in 69.2%; and the false lumen was partially or completely thrombosed in 75.0% of patients.

September 19, 2016
New Data Presented in VIVA Late Breaking Clinical Trials Demonstrate Durability, Safety and Efficacy for the Medtronic In.Pact Admiral DCB
IN.PACT Drug-coated balloon
The IN.PACT SFA Trial enrolled 331 patients at 57 sites across Europe and the United States who were randomized to treatment with either the IN.PACT Admiral DCB or plain balloon angioplasty (percutaneous transluminal angioplasty, or PTA). The data demonstrate strong durability through three years with superior performance in both primary patency (69.5% compared to 45.1% in the PTA group (p<0.001)) and clinically-driven target lesion revascularization (CD-TLR) (15.2% compared to 31.1% in the PTA group (p=0.002)).

September 16, 2016
Coronary Angioplasty Enters Its 40th Year
Maria Schlumpf making PTCA balloon on kitchen table
(Commentary from the Editor's Blog - includes video) Today marks the 39th anniversary of the first percutaneous transluminal coronary angioplasty (PTCA) which was performed in 1977 by Dr. Andreas R. Gruentzig in Zurich, Switzerland. This angioplasty procedure utilized an expandable balloon, fashioned on a kitchen table in Gruentzig’s apartment by Gruentzig’s assistant, Maria Schlumpf. The first patient was 37-year-old Adolph Bachman, the same age as Gruentzig himself.

September 13, 2016
Medtronic's IN.PACT Drug-Coated Balloon: First to Gain FDA OK for Treatment of In-Stent Restenosis in the Peripheral Vessels
IN.PACT™ Admiral™ drug-coated balloon (DCB)
The FDA has approved the first drug-coated balloon in the United States for the treatment of in-stent restenosis (ISR) in the peripheral arteries: Medtronic's IN.PACT Admiral drug-coated balloon (DCB). One-year outcomes from the IN.PACT Global ISR Imaging Cohort were presented at last year's VIVA meeting: the primary patency rate was 88.7% the clinically-driven target revascularization (CD-TLR) rate was 7.3%, outcomes that begin to approach what has been seen in the coronaries.

August 30, 2016
NORSTENT: Drug-Eluting Stents – Doing What They’re Supposed To
various stents
At this week’s annual European Society of Cardiology Congress in Rome, an important randomized clinical trial on stents was presented by Professor Kaare H. Bønaa, MD, PhD. Called NORSTENT, short for the “Norwegian Coronary Stent Trial,” this was the largest stent trial ever conducted, with 9,013 patients followed for six years. That’s serious!


August 29, 2016
Medtronic Technologies Improve Delivery of Cardiac Resynchronization Therapy
Medtronic plc (NYSE:MDT) today announced results from the Cardiac Resynchronization Therapy Efficacy Enhancement (CRTee) study. The study showed that the Medtronic-exclusive device-based EffectivCRT™ during AF algorithm improves therapy delivery in heart failure patients with atrial fibrillation (AF). The results were presented at the 2016 European Society of Cardiology (ESC) Congress in Rome.

August 28, 2016
New Long-Term Data Reinforce Safety Benefits of the World's Smallest Pacemaker
Micra Pacemaker compared to a Nickel
In the largest and longest clinical evaluation of leadless pacing patients to date, Medtronic plc (NYSE: MDT) today announced new long-term results from the Medtronic Micra® Transcatheter Pacing System (TPS) Global Clinical Trial in a clinical trial update late-breaking session at the 2016 European Society of Cardiology (ESC) Congress in Rome.

August 25, 2016
AimRADIAL Masterclass V + FFR Workshop in Budapest
Parliament Building in Budapest, Hungary
On September 22-23, 2016, the 5th Advanced International Masterclass on the Transradial Approach will be held in Budapest, Hungary. And this year, AimRADIAL will be preceded on September 21 by a one-day comprehensive workshop covering all aspects of Fractional Flow Reserve (FFR) from the basic principles and set-up in the cath lab, to the differences between FFR, iFR, and CFR, a comprehensive review of the clinical study data so far, and finally a look at future modalities, like FFR-CT.

August 21, 2016
SAPIEN3 Transcatheter Aortic Valve Gets FDA Approval for Patients at Intermediate Risk for Surgery
Edwards SAPIEN 3 valve
Edwards has received an important expansion of indications for its Transcatheter Aortic Valve (TAVR), the SAPIEN3. Initially approved only for patients at high risk for open surgery, the FDA has now approved use of the SAPIEN3 for patients at "intermediate risk" for surgery, specifically those who, according to the FDA announcement "are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality > 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator)."

August 4, 2016
Can Drug-Coated Balloon plus Atherectomy Be a Successful Treatment for Calcified FemPop PAD?
HawkOne atherectomy device and IN.PACT drug-coated balloon
Medtronic and VIVA Physicians have launched the REALITY study: to see if directional atherectomy, combined with a drug-coated balloon, is a successful therapeutic option for these difficult cases of calcified and symptomatic femoropopliteal peripheral artery disease (PAD). The study will enroll around 150 patients, who will be treated with Medtronic's HawkOne or TurboHawk atherectomy devices, and then the IN.PACT Admiral paclitaxel drug-coated balloon. Patients will be followed for two years.

August 3, 2016
Boston Scientific Issues Urgent Lotus Valve Recall
Boston Scientific's Lotus™ Valve for TAVR
Boston Scientific has issued a global recall of all Lotus™ transcatheter aortic valves that were manufactured before March 2016. The problem with the Lotus Valve was not with the valve itself, but with a component of the delivery system. The problem was fixed via a manufacturing change in March, but the previously manufactured product had not been recalled, and is now implicated in three patient deaths due to catastrophic vessel trauma.

August 1, 2016
CoreValve Evolut R First TAVR to Receive CE Mark for Intermediate Risk Patients
Corevalve Evolut R in situ
This morning Medtronic plc (NYSE: MDT) announced that its recapturable and repositionable CoreValve Evolut R System has received the CE Mark to treat patients with severe aortic stenosis who are at intermediate risk for open-heart surgery, making the CoreValve Evolut R the first TAVR device to obtain approval for this patient population. Previously TAVR devices were indicated for use only in patients at high risk for surgery.

July 24, 2016
Will Abbott's Absorb Bioresorbable Vascular Scaffold Revolutionize Treatment of Coronary Artery Disease?
Absorb BVS with question mark
In Part One of this feature, we reported on the various positives and negatives of the BVS, as presented to the FDA panel that recommended approval. Now that this device has been approved by the FDA, we discuss in Part Two the Absorb's potential impact in the United States with three leading interventional cardiologists, Drs. Ajay Kirtane, James Blankenship, and Daniel Simon.

July 14, 2016
Health Canada Approves Abbott's Absorb™ Bioresorbable Stent, the First Fully Dissolving Heart Stent
photo of the Absorb Bioresorbable Vascular Scaffold (BVS)
Abbott (NYSE: ABT) announced today that Health Canada has approved the company's Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people in Canada with coronary artery disease. Abbott's Absorb heart stent is a first-of-its-kind medical device that is made of a naturally dissolving material. After opening up a clogged heart artery, Absorb completely dissolves in about three years.

July 13, 2016
Medtronic Receives FDA Approval for IN.PACT Admiral DCB 150 mm Lengths
IN.PACT Admiral drug-coated balloon (DCB)
Medtronic plc (NYSE: MDT) has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT™ Admiral™ drug-coated balloon (DCB) in longer, 150 mm lengths. The new 150 mm length balloon, available in four, five, and six mm diameters, will provide greater treatment options for long lesions in patients with peripheral artery disease (PAD).

July 5, 2016
FDA Approves Abbott's Absorb™ Bioresorbable Stent, The Only Fully Dissolving Heart Stent
photo of the Absorb Bioresorbable Vascular Scaffold (BVS)
Abbott announced today that the U.S. Food and Drug Administration has approved the company's Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people with coronary artery disease in the United States. Absorb disappears completely[1] in approximately three years, after it has done its job of keeping a clogged artery open and promoting healing of the treated artery segment.

May 15, 2016
Philips Volcano Activities at EuroPCR
Palais des Congrès, Paris
At this year's EuroPCR meeting in Paris, Philips will be celebrating the one-year anniversary of its partnership (read "acquisition") of Volcano Corporation, making it the only cath lab imaging manufacturer able to offer intravascular options such as intravascular ultrasound (IVUS), fractional flow reserve (FFR) and its own proprietary non-adenosine functional measurement technology, iFR.

May 13, 2016
InterZENtion: Transradial PCI as an Art
Dr. Ferdinand Kiemeneij
Dr. Ferdinand Kiemeneij, the pioneer of transradial intervention, has a new book out. And you should buy it. It's titled, "Transradial Coronary Interzentions" and in it, Dr. Kiemeneij brings together a whole range of concepts that he has explored and has been practicing, and insights that have come from his experiences both inside and outside the hospital. He says, "This book is one of a kind and focuses more on the 'soft sides' of interventional cardiology (mindset, preparations, minimally invasive, traceless, minimal use of materials). I bring Taoist and Zen core values into the cath lab. The book is illustrated by many B&W photos that I have made during my frequent travels. I am convinced that these views are especially of value for young interventionalists. I consider [this book] to be the summit of my work."

May 11, 2016
An American Cardiologist in Paris
movie poster for Frantic
Next week more than 12,000 cardiologists will stream into the Palais des Congrès in Paris to make presentations and learn about stents, angioplasty, fractional flow reserve, intravascular ultrasound, dual antiplatelet therapy, etc. It’s the annual EuroPCR meeting, “the world-leading course in interventional cardiovascular medicine.” Just be careful in the shower and don’t answer the phone. Especially if you’re traveling with your wife!

April 6, 2016
FDA OK to Medtronic's Micra: World's Smallest and 1st Transcatheter Pacemaker Approved in U.S.
Micra Pacemaker compared to a Nickel
Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval of the world's smallest pacemaker, the Medtronic Micra Transcatheter Pacing System (TPS). The Micra TPS is the first FDA-approved product with miniaturized pacing technology. It is cosmetically invisible and small enough to be delivered through a catheter and implanted directly into the heart -providing a safe alternative to conventional pacemakers without the complications associated with cardiac wires (leads).

April 3, 2016
Medtronic CoreValve® System Maintains Survival Advantages Over Surgery in High Risk Aortic Stenosis Patients at Three Years
Corevalve on blue background
Medtronic today announced new data from the High Risk Study of the CoreValve U.S. Pivotal Trial that show superior clinical outcomes for transcatheter aortic valve replacement (TAVR) with the CoreValve System compared to surgical aortic valve replacement (SAVR) out to three years. Of the 407 patients (228 TAVR; 179 SAVR) followed out to three years in the randomized High Risk Study, patients treated with the CoreValve System showed superior outcomes compared to surgery for the combined endpoint of all-cause mortality or stroke (37.3% vs. 46.7%; p=0.006) and for all stroke (12.6% vs. 19.0%; p=0.03). All-cause mortality continued to be numerically lower for TAVR compared to SAVR-treated patients (32.9% vs. 39.1%; p=0.07).

April 3, 2016
Edwards SAPIEN 3 TAVR Demonstrates Clinical Superiority To Surgery In PARTNER II Study
Edwards SAPIEN 3 valve
Edwards today announced that new data on patients at intermediate risk for open-heart surgery demonstrated that transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve was superior to surgery at one year on a composite primary endpoint of mortality, stroke and moderate or severe aortic regurgitation. In addition, the SAPIEN 3 valve demonstrated clinical superiority at one year on individual assessments of all-cause mortality and of stroke.

April 3, 2016
Medtronic Announces Early Data and Completes Enrollment in CE Mark Cohort in Drug-Filled Stent Trial
Laser-drilled abluminal holes in Medtronic's Drug-Filled Stent
Medtronic plc (NYSE: MDT) announced new clinical data today from one of the endpoints in the RevElution Trial for its novel, next-generation Drug-Filled Stent (DFS). These new data showed rapid vessel healing without inflammation in Optical Coherence Tomography (OCT) data of the complete one-month follow-up patient cohort.


April 2, 2016
Medtronic CoreValve® System Demonstrates Superior Survival to Surgery in Aortic Stenosis Patients with Lower STS Scores
CoreValve in heart
The analysis of the sub-cohort compared 202 patients treated with the CoreValve System against 181 patients who received surgical aortic valve replacement (SAVR). The CoreValve TAVR patients demonstrated superior outcomes in all-cause mortality at two years compared to patients treated with surgical aortic valve replacement (15.0% vs. 26.3%; p=0.01). In addition, rates of combined all-cause mortality or major stroke were superior for TAVR with the CoreValve System (17.1% vs. 31.9%; p=0.0018).

April 1, 2016
Philips Volcano Announces More Than 5,000 Coronary Artery Disease Patients Enrolled in iFR Outcomes Trials
Dr. Patrick Serruys
Royal Philips (NYSE: PHG; AEX: PHIA) today announced that a combined total of more than 5,000 patients have been enrolled in three prospective clinical studies to assess the safety of deferring cardiovascular interventions using Philips Volcano’s proprietary iFR (instant wave-Free Ratio) pressure measurement technology versus conventional FFR (Fractional Flow Reserve) measurements.

March 31, 2016
First Patients Enrolled in Medtronic Trial in Low-Risk Aortic Stenosis Patients
CoreValve® Evolut® R Transcatheter Aortic Valve in Situ
Medtronic plc (NYSE: MDT) today announced that the first patients were enrolled in the expanded indication trial for the CoreValve® Evolut® R System, the first and only next-generation recapturable, self-expanding transcatheter aortic valve replacement (TAVR) system commercially available in the United States.


March 29, 2016
Societies Update Guidelines for Dual Antiplatelet Therapy
pills and a stent
The American College of Cardiology and the American Heart Association today released updated guidelines for dual antiplatelet therapy in patients with coronary artery disease. In general, duration of dual antiplatelet therapy recommendations in the document consist of a Class I recommendation of “should be given” for a minimum time period of time (usually six to 12 months).

March 21, 2016
Part One: FDA Panel Recommends Abbott's Absorb Bioresorbable Vascular Scaffold for Approval
Abbott's
This is the first installment of a two part feature regarding current thinking about the Bioresorbable Vascular Scaffold. Part One discusses the history and some general background issues surrounding the device; Part Two (to be posted later this week) consists of comments from leading interventional cardiologists about the current and future implications, predictions, critiques, and recommendations for the utilization of BVS.

March 16, 2016
Opsens Receives FDA 510(K) Clearance for the OptoWire II
Opsens FFR wire in blockage
This approval allows Opsens to market the OptoWire II in the world’s largest market. The OptoWire II is a new design comprising a hydrophilic coating that further improves the performances of the guidewire in different scenarios, such as in highly calcified and tortuous vessels.


March 15, 2016
Abbott's Absorb™, the First Fully Dissolving Heart Stent, Earns Positive Review by FDA Advisory Committee
Artist rendition of Abbott's Absorb BVS
Abbott (NYSE: ABT) announced today that an independent panel of experts convened by the U.S. Food and Drug Administration (FDA) voted 9 to 0, with one abstention, that the benefits of Abbott's Absorb fully bioresorbable drug eluting coronary stent outweigh the risks.


March 10, 2016
St. Jude Medical Secures CE Mark Approval of MRI Compatibility for the Nanostim Leadless Pacemaker
Nanostim™ leadless pacemaker, compared to a Euro
St. Jude Medical, Inc. (NYSE:STJ) today announced CE Mark approval for magnetic resonance (MR) conditional labeling for 1.5 T scans for the company’s Nanostim™ leadless pacemaker. With the approval, throughout Europe both existing patients implanted with a Nanostim leadless pacemaker and new patients receiving a Nanostim leadless pacemaker in the future can safely undergo full-body MRI diagnostic scans.

March 7, 2016
Medtronic Begins CoreValve™ Evolut™ R "Real World" TAVR Study
CoreValve® Evolut® R Transcatheter Aortic Valve
Medtronic plc (NYSE: MDT) has announced the start of a new "real world" study of its CoreValve Evolut R transcatheter aortic valve. The first patients were enrolled at University Hospital in Bonn, Germany. The FORWARD study will enroll up to 1,000 patients at 60 centers worldwide.


March 6, 2016
Pete Nicholas to Retire as Boston Scientific Board Chairman
Pete M. Nicholas
Major medical device company Boston Scientific (NYSE:BSX) has announced that Pete Nicholas, its long-serving Chairman of the Board of Directors and co-founder, will formally retire from the Board in May. Founded almost four decades ago by Nicholas and John Abele, who met at their sons' soccer game in Massachusetts, Boston Scientific became one of the leading manufacturers of medical devices used in the interventional treatment of heart disease, stroke and more.

February 23, 2016
FDA Approves New CoreValve Low-Risk TAVR Study
CoreValve® Evolut® R Transcatheter Aortic Valve
Medtronic (NYSE: MDT) has announced FDA approval for a new study of transcatheter aortic valve replacement (TAVR). But this trial is different; this trial will be in patients at low-risk for the standard surgical procedure (SAVR). The device will be Medtronic's latest TAVR iteration, the CoreValve® Evolut® R, approved last June by the FDA, and will include 1,200 patients at up to 80 sites.

February 22, 2016
Medtronic Receives CE Mark for Full Line of Cardiac Resynchronization Therapy-Defibrillators Compatible with MRI Scans
Medtronic Compia MRI™ Quad CRT-D SureScan®
Medtronic plc (NYSE:MDT) today announced that it has received CE (Conformité Européenne) Mark for the first and only cardiac resynchronization therapy defibrillators (CRT-Ds) approved for 3 Tesla (T) magnetic resonance imaging (MRI) scans, providing CRT-D patients with access to the most advanced imaging diagnostic procedures available.

February 22, 2016
CE Mark for Boston Scientific's Eluvia Peripheral Stent
Eluvia™ Drug-Eluting Vascular Stent
Boston Scientific (NYSE: BSX) announced this morning that its Eluvia™ Drug-Eluting Vascular Stent has received the CE Mark for use in treating peripheral artery disease in the superficial femoral and proximal popliteal arteries. The company states that the Eluvia is the first polymer-based DES approved in Europe for use in the peripheral arteries.


February 18, 2016
Meta-Analysis Shows Medtronic's Solitaire™ Stent Retriever Device Improves Functional Outcomes for Acute Ischemic Stroke Patients; Reduced Mortality in Patients 80+
Medtronic's Solitaire™ stent retriever
A meta-analysis published online today in Stroke and presented at the International Stroke Conference (ISC) in Los Angeles, Calif., found that the addition of Medtronic plc's (NYSE: MDT) Solitaire™ stent retriever to current pharmaceutical treatment (IV-tPA) significantly improves functional outcomes in patients suffering stroke. The analysis also showed a significant reduction (20% vs. 40%, adjusted OR 3.7(1.3-10.6), p=0.01) in mortality for patients over the age of 80.

February 10, 2016
Study of Medtronic's Valiant TAAA (Thoracoabdominal Aortic Aneurysm) Stent Graft Begins
Medtronic’s Valiant TAAA Stent Graft
Medtronic plc (NYSE:MDT) has announced that the first patient has been treated with Medtronic’s Valiant TAAA, a new, minimally invasive stent graft system designed to treat thoracoabdominal aortic aneurysms (TAAA). The patient's treatment begins the physician-sponsored, investigational device exemption study (PSIDE) at Sanford Health in Sioux Falls, South Dakota.

February 10, 2016
"Alarming" Increase in Heart Attacks Among Young Adults in India Due to Smoking and Lifestyle
Logo of the Cardiological Society of India
"Stop Smoking!" is the heightened warning for young adults in India, based on a study presented today at the 67th Annual Conference of the Cardiological Society of India. The study looked at 310 patients who presented with acute coronary syndrome (ACS) during a two-year period to the Casualty (Emergency) Department of Sir Sunderlal Hospital. The frightening statistic is that the average age of these patients was 30 years old. The patients were almost all male, 90%, with the youngest ACS patient only 15 years of age.

February 9, 2016
New Real-World Comparison Showing Similar Efficacy Between the Lutonix® and In.Pact™ Drug-Coated Balloons Featured at LINC 2016
Lutonix (L) and IN.PACT (R) Drug-Coated Balloons
Professor Dierk Scheinert, M.D., Head of the Department of Interventional Angiology at the University of Leipzig in Germany, commented, “These single-center results, like others before, show that real-world patients are benefiting from drug-coated balloon technology; and furthermore, the study indicates that there is no significant difference in the need for revascularization following treatment with either of these two DCBs.”

February 9, 2016
St. Jude Launches Mobile OCT/FFR/Angio System for Cath Labs in Europe and Japan
OPTIS Mobile Integrated Lab with OCT
St. Jude Medical (NYSE:STJ) recently announced that it has launched a mobile version of its OPTIS™ Integrated System in Japan and Europe. Like its built-in console cousin, the new system, dubbed OPTIS Mobile System, brings together optical coherence tomography (OCT), fractional flow reserve (FFR) and standard angiography.


February 5, 2016
FDA Nod to Medtronic MR-Conditional CRT-Defibrillators
Medtronic Compia MRI™ Quad CRT-D SureScan®
The U.S. FDA has cleared the first and only MR-conditional cardiac resynchronization therapy defibrillators (CRT-Ds) for the treatment of heart failure: Medtronic's Amplia and Compia MRI™ Quad CRT-D SureScan® systems. This approval expands Medtronic’s portfolio to include a complete line of MR-conditional cardiac devices, including MR-conditional pacemakers, implantable cardiac defibrillators (ICDs), insertable cardiac monitors (ICMs) and now CRT-Ds.

February 4, 2016
40 Years Ago, There Was a Poster at the American Heart Association Meeting....
Gruentzig's 1976 AHA poster
(Commentary from the Editor's Blog) -- Today being TBT (Throw Back Thursday) on Twitter, Dr. Jordan Safirstein (@CardiacConsult) posted a photo this morning of a poster that appeared 40 years ago at the 1976 American Heart Association meeting. It’s a meaningful poster, since it was the first public presentation of the concept and initial studies of something called coronary angioplasty. Check out my video clip.

February 3, 2016
FDA OKs Expanded Patient Population for CoreValve
CoreValve (artist rendition)
Medtronic plc (NYSE:MDT) announced today that the FDA has revised the IFU (Instructions for Use) labeling for the CoreValve System to now include patients with end-stage renal disease and low flow, low gradient aortic stenosis. Previously, physicians were cautioned in the IFU against treating these patient populations with TAVR because of their severe comorbidities. The FDA's decision was based on positive data from the CoreValve U.S. Expanded Use Study.

February 1, 2016
CE Mark for 4.5 and 5.0mm Sizes of Medtronic Resolute Onyx Drug-Eluting Stent
Dr. David Hildick-Smith
Today the European regulatory agency, Conformité Européene, approved new sizes of Medtronic's drug-eluting stent, the Resolute Onyx™, in 4.5 and 5.0mm diameters. Additionally the device received the CE Mark for the treatment of the left main artery. Dr. David Hildick-Smith told Angioplasty.Org, "I think it is an excellent development that we will now have a DES which is ideally suited to the diameter of the Left Main. Previously we have had to take smaller stents and post-dilate them to the desired diameter and on occasions this might result in overstretching of the stent with loss of the ideal stent-to-artery ratio and drug concentration."

January 29, 2016
FDA Panel to Look At Data on Medtronic's Miniature Leadless Micra® Pacing System
Micra Pacemaker compared to a Nickel
Medtronic plc announced today that it will present data on its Micra® miniaturized leadless pacemaker to the FDA's Circulatory System Devices Panel on February 18. The Micra gained the CE Mark European approval in April and Medtronic has presented data in support of the Micra's safety and efficacy at several meetings, most recently at the American Heart Association meeting in November, with simultaneous publication of the results in the New England Journal of Medicine.

January 25, 2016
Patient Education About Aortic Stenosis? There's an App for That!
iPad with app
Medtronic, manufacturer of both surgical and percutaneous valves, has developed an easy-to-use iPad app, explaining the disease, its treatment options and, importantly, what happens after discharge from the hospital, when the level of care is reduced and additional support becomes very important. Dubbed the "Aortic Stenosis Patient Journey iPad App," nursing staff, as well as patients and their family, can download this tool from the iTunes store for free.

January 24, 2016
Svelte Launches Its Slender IDS Stent-on-a-Wire System in Europe
Svelte SLENDER stent (R) vs. standard DES (L)
New Jersey-based Svelte Medical Systems, Inc. announced this week the launch of its novel SLENDER IDS stent-on-a-wire in Europe and other countries that accept the CE Mark. Svelte is planning to submit a PMA application to the US FDA this year. The SLENDER IDS gained the CE Mark last month and the company is now making the product available to select accounts in Europe that specialize in the transradial approach.

January 21, 2016
Clinical Trial of Novel Infusion Device for Below the Knee Angioplasty Begins in Germany
rof. Dr. Dierk Scheinert
University Hospital of Leipzig
Today Mercator MedSystems announced the start of a clinical trial for its Bullfrog® Micro-Infusion Device which will treat the blockage post-angioplasty (or atherectomy) with a dose of dexamethasone, an anti-inflammatory steroid, in the hopes of preventing the build-up of scar tissue which leads to restenosis of the vessel. Prof. Dr. Dierk Scheinert commented, "We are very excited with the start of this important clinical trial. There remains a real need for enhancements in therapy for treating patients with critical limb ischemia (CLI). We aim to show with this trial that the therapy can improve the outcomes in this desperate condition."

January 15, 2016
Edwards Receives FDA Approval For Expanded Indication Study Of SAPIEN 3 Valve
Edwards SAPIEN 3 valve
Edwards today announced FDA approval for an expanded indication study of its most advanced transcatheter aortic heart valve, the Edwards SAPIEN 3 valve. The investigational device exemption (IDE) study will enroll elderly patients with severe, symptomatic aortic stenosis (AS) who have been determined by a heart team to be at low risk for mortality if they were to undergo surgical aortic valve replacement.

January 11, 2016
Medtronic IN.PACT Admiral DEB Receives CE Mark for Treatment of AV Access In Patients with End-Stage Renal Disease
patient on dialysis
Medtronic plc (NYSE:MDT) today announced that the IN.PACT® Admiral® drug eluting balloon has received CE (Conformité Européene) Mark for arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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