Is 2019 Going to Be a Standout Year for TAVR?
JenaValve has won a nod from FDA for expanded IDE enrollment of its transcatheter aortic valve replacement (TAVR) system. The agency’s nod is aimed at feasibility studies for the JenaValve Pericardial TAVR System with the Everdur transcatheter heart valve and expands eligible enrollment from 20 patients to 80 at high or extreme surgical risk.
The Irvine, CA-based company said the prospective IDE studies are part of a larger, ongoing CE Mark clinical program investigating the JenaValve Pericardial TAVR System for the same indications at centers of excellence in Europe and New Zealand.
Approval for addition...
Source: MDDI - December 4, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
Pivotal trial kicks off for Edwards Lifesciences ’ Pascal mitral repair device
A pivotal trial of Edwards Lifesciences’ (NYSE:EW)Pascal mitral valve repair system is now underway, with the first procedure being performed this week at Atlantic Health System’s Morristown Medical Center, the group said.
The study, dubbed the Clasp IID trial, will explore the safety and efficacy of Irvine, Calif.-based company’s Pascal TMVR system in treating patients with degenerative mitral valve regurgitation, the research institution said.
“As a nationally ranked heart hospital, Morristown Medical Center is proud to be the first hospital in the world to implant this device as part of this piv...
Source: Mass Device - December 4, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Source Type: news
Lipoprotein(a) Shows Linear Link With Aortic-Stenosis Progression Lipoprotein(a) Shows Linear Link With Aortic-Stenosis Progression
Elevated levels of lipoprotein(a) -Lp(a) - and associated compounds are tied to a higher rate of calcific aortic-valve stenosis (CAVS), according to a secondary analysis of trial data.Reuters Health Information (Source: Medscape Pathology Headlines)
Source: Medscape Pathology Headlines - December 4, 2018 Category: Pathology Tags: Cardiology News Source Type: news
FDA OKs expanded JenaValve study
JenaValve Technology said today that the FDA approved the expansion of its investigational device exemption trials for the transcatheter aortic valve replacement it’s developing.
The JenaValve system consists of the Everdur valve and Coronatix delivery catheter. The FDA decision expands the feasibility study from 20 extreme- or high-risk patients to 80 patients with either aortic stenosis or aortic regurgitation, the Irvine, Calif.-based company said. JenaValve said the IDE studies are part of its larger CE Mark program in Europe and New Zealand.
“We are extremely pleased with the initial clinical results, a...
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Featured Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves JenaValve Source Type: news
Nov 30, 2018 This Week in Cardiology Nov 30, 2018 This Week in Cardiology
TAVR vs surgery for high-risk aortic stenosis, conflicts of interest for physicians and societies, spin in the CV literature, and low-carb diets are discussed in this week ’ s podcast.theheart.org on Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 30, 2018 Category: Consumer Health News Tags: Cardiology Commentary Source Type: news
Asymptomatic Severe Aortic Stenosis in Individuals > 80 Years Asymptomatic Severe Aortic Stenosis in Individuals > 80 Years
Should asymptomatic severe aortic stenosis be treated in the very old?Journal of the American Geriatrics Society (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 29, 2018 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news
Survival and Stroke Similar for TAVR and SAVR at 5 Years Survival and Stroke Similar for TAVR and SAVR at 5 Years
The early mortality benefit seen with transcatheter aortic valve replacement over surgical repair in patients with severe aortic stenosis at high surgical risk is no longer significant at 5 years.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 26, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news
Edwards & #039; Sapien 3 Ultra Valve Wins CE Mark
As expected, Edwards Lifesciences has secured a CE mark for its Sapien 3 Ultra device, but the company won't be able to release the new transcatheter aortic valve replacement (TAVR) system in Germany due to a recent preliminary injunction from Boston Scientific. The CE mark allows Edwards to market the device in Europe for patients with severe, symptomatic aortic stenosis.
"Edwards is disappointed in Boston Scientific's tactic to limit access of this new therapy," the company said in a press release. The Germany case involves a European patent  Boston Scientific acquired in 2017 when it boughtÂ...
Source: MDDI - November 16, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis.
Despite winning a CE Mark, Edwards said that the new valve will not be launched in Germany due to a preliminary injunction from rival Boston Scientific (NYSE:BSX). The company said that “the German court will hold a full hearing on the merits of the dispute” mid-next year, and that it is hopeful it will prevail.
The company said it will introduce the Sapien 3 Ultra in the rest of Europe as pa...
Source: Mass Device - November 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Featured Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news
SURTAVI: Fewer Early Strokes, Better QOL With TAVR vs SAVR SURTAVI: Fewer Early Strokes, Better QOL With TAVR vs SAVR
Intermediate-risk patients with aortic stenosis are usually treated with SAVR, but new data suggest TAVR may be more effective in preventing early strokes and improving quality of life.Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - October 30, 2018 Category: Neurology Tags: Cardiology News Source Type: news
Edwards Lifesciences posts mixed bag Q3 earnings
Edwards Lifesciences (NYSE:EW) today posted third quarter earnings that topped earnings per share consensus on Wall Street but missed on revenue expectations.
The Irvine, Calif.-based company posted profits of $225.9 million, or $1.08 per share, on sales of $906.6 million for the three months ended September 30, seeing the bottom line grow 32.8% while sales grew 10.4% when compared to the same period during the previous year.
Adjusted to exclude one-time items, earnings per share were 1.07¢, just ahead of the $1.02 consensus on The Street, where analysts were looking for sales of $928.2 million, which the company missed...
Source: Mass Device - October 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat Edwards Lifesciences Source Type: news
Early AVR in Asymptomatic Severe Aortic Stenosis: New Support Early AVR in Asymptomatic Severe Aortic Stenosis: New Support
' We think it should be a class I recommendation ' that such patients with certain echocardiographic risk markers be considered for surgical or transcatheter aortic valve replacement, said a researcher.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 10, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news
‘ Take Action ’ : Dave McGillivray ’s Message To Anyone Ignoring Symptoms Of Heart Disease
BOSTON (CBS) – There aren’t many people who run their age in miles every year. Dave McGillivray does. From the time he was a boy, he’s celebrated his good health and love of running with a personal challenge that obviously gets more challenging with age. His last “full” birthday run was last year: 63 miles.
This year, by necessity, he split the effort into 32 miles of running and 32 miles of biking. A feat, to be sure. But this year, he is facing a challenge for which there is no training. McGillivray, arguably one of the most fit people on the planet, has coronary artery disease and is preparing to undergo ...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - October 9, 2018 Category: Consumer Health News Authors: Health – CBS Boston Tags: Boston News Health Seen On WBZ-TV Syndicated Local Watch Listen Dave McGillivray Lisa Hughes Mass General Hospital Source Type: news
Edwards launches US pivotal Centera self-expanding TAVR study
Edwards Lifesciences (NYSE:EW) said yesterday it launched a U.S.-based pivotal trial of its self-expanding Centera transcatheter aortic valve, exploring its use in treating severe symptomatic aortic stenosis in intermediate risk patients.
The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Edwards said.
The Irvine, Calif.-based company said it hopes to enroll approximately 1,000 patients in the trial, which will include a bicuspid registry. The endpoint fo...
Source: Mass Device - October 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Replacement Heart Valves Edwards Lifesciences Source Type: news
Silent Aortic Stenosis Outcomes Good With Close Surveillance
(MedPage Today) -- Midterm survival rates high with medical management in registry (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - October 3, 2018 Category: Cardiology Source Type: news
