Filtered By:
Specialty: Medical Devices
Condition: Aortic Stenosis
This page shows you your search results in order of date.
Order by Relevance | Date
Total 28 results found since Jan 2013.
Transcatheter aortic valve replacement: clinical safety and performance data.
Authors: van Baal JWPM, Roszek B, van Elk M, Geertsma RE
Abstract
Introduction: Patients with severe aortic stenosis and regurgitation who are inoperable or at high-risk for surgery can be treated with transcatheter aortic valve replacement (TAVR). The aim of this study was to provide a comprehensive overview of the literature of TAVR and reported clinical and performance outcomes. Areas covered: A total of 16 devices, described in 204 articles describing clinical and performance outcomes, were included. The most frequently observed outcome was 30-day mortality, ranging between 0-23%. Other commonly reported clinic...
Source: Expert Review of Medical Devices - October 1, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research
New Expanded Indication Could Change the TAVR Narrative
The transcatheter aortic valve replacement market received one of the biggest jolts of the year when FDA expanded indications of both Edwards Lifesciences and Medtronic’s valves.
FDA’s measure would open up the valves to be used in younger and low-risk patients. The agency said these transcatheter valves – Edwards’ Sapien 3, and Sapien 3 Ultra, with Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – were previously indicated only for patients at intermediate or higher risk for death or major complications duri...
Source: MDDI - August 19, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news
ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology.
Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine.
Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at inte...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news
Study of Boston Scientific ’s Lotus, Medtronic’s CoreValve shows similar outcomes at 2 years
Two-year results from a head-to-head study comparing transcatheter aortic heart valve replacement devices from both Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) indicated similar outcomes for the competing products.
The study, published recently in the journal JAMA Cardiology, compared Marlborough, Mass.-based Boston Scientific’s Lotus valve to Fridley, Minn.-based Medtronic’s CoreValve system.
Investigators in the study compared outcomes for 912 patients with high or extreme risk and severe, symptomatic aortic stenosis after treatment with one of the two devices.
Patients, treated between September 22, 2014...
Source: Mass Device - February 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Replacement Heart Valves Boston Scientific Medtronic Source Type: news
Transcatheter aortic valve replacement: relative safety and efficacy of the procedure with different devices.
Authors: Del Val D, Ferreira-Neto AN, Asmarats L, Maes F, Guimaraes L, Junquera L, Wintzer J, Fischer Q, Barroso de Freitas Ferraz A, Puri R, Rodés-Cabau J
Abstract
INTRODUCTION: Transcatheter aortic valve replacement (TAVR) is a well-established treatment for patients with severe aortic stenosis and intermediate-to-high surgical risk. The increasing clinical experience along with technical and design iterations of transcatheter valve systems have contributed to reducing adverse events and improving clinical outcomes. Areas covered: Overview of the latest generation transcatheter heart valves (THVs), focusing on e...
Source: Expert Review of Medical Devices - December 13, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research
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
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
MassDevice EuroPCR 2018 Roundup
Valve Tech Roundup – Transcath heart valves getting safer, seeing expanded use
Abbott touts initial data from Portico TAVR study
Abbott (NYSE:ABT) today released 30-day data from a study of its Portico transcatheter aortic valve replacement, touting excellent clinical outcomes and low rates of death, disabling stroke and paravalvular leak.
The real-world, multicenter, prospective, single-arm Portico I study aimed to explore the safety and efficacy of the Portico valve with independent adjudication of clinical events and independent echocardiography core-lab analysis.
Investigators in the study will follow pa...
Source: Mass Device - May 22, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Abbott Edwards Lifesciences Esaote Source Type: news
Edwards Adds Bold New Chapter to TAVR Story
Edwards Lifesciences just might have leaped-frogged over some of its competitors in the burgeoning TAVR market. The undisputed TAVR pioneer has received CE mark for its Centera valve to treat severe, symptomatic aortic stenosis patients at high risk of open-heart surgery.
The Edwards Centera valve is repositionable and retrievable and can be delivered through a low-profile, 14-French, motorized delivery system. The company said the device is packaged with the valve fully pre-attached to the delivery system, which helps with simple and rapid device preparation.
Network with your colleagues in medtech at ADM Cleveland, ...
Source: MDDI - February 15, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Medical Device Business Source Type: news
Edwards Lifesciences wins CE Mark for Centera TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery.
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 Irvine, Calif.-based company said.
“With the Edwards Centera valve, European clinicians and their patients may now benefit from a self-expanding ...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news
3 Reasons TAVR Will Continue to Prosper
The transcatheter aortic valve replacement (TAVR) market has already seen rapid growth, and today represents a $3 billion market globally. But the leading TAVR companies say the current technology and approved indications barely scratches the surface in terms of the true growth potential of the space.
Michael Mussallem, CEO of Edwards Lifesciences, told J.P. Morgan Healthcare Conference attendees on Monday that the global TAVR market is expected to exceed $5 billion by 2021, and that number does not include certain indications that are currently being explored, like treatment for patients with asymptomatic aortic stenosi...
Source: MDDI - January 9, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news
Medtronic launches post-market study of CoreValve Evolut Pro heart valve
Medtronic (NYSE:MDT) said today it launched a post-market clinical study of its CoreValve Evolut Pro valve, looking to evaluate performance out to 5 years for the self-expanding transcather aortic valve implantation system.
The multi-center, prospective single-arm study aims to enroll 600 patients across 35 European sites to evaluate the safety of the CoreValve Evolut Pro, including all-cause mortality and all stroke at 30 days and clinical performance including valve hemodynamics and paravalvular regurgitation.
“We look forward to replicating the excellent clinical outcomes demonstrated by the Evolut Pro valve in a...
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Medtronic Source Type: news
Medtronic wins CE Mark for CoreValve Evolut Pro
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its CoreValve Evolut Pro transcatheter aortic heart valve, indicated for the treatment of severe aortic stenosis for symptomatic patients at intermediate, high or extreme risk for open heart surgery
The CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said.
“We are excited to introduce the next evolution of our Evolut TAVI platform to provide physicians in Europe with a comprehensive portfolio to ...
Source: Mass Device - July 31, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news
FDA clears Medtronic ’ s CoreValve Evolut TAVR in intermediate risk patients
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its CoreValve Evolut transcather aortic valve replacement platform, now indicated for patients with symptomatic severe aortic stenosis who are at an intermediate risk for open heart surgery.
The Fridley, Minn.-based company said that patients at intermediate risk for open-heart surgery have a mortality risk of greater than or equal to 3% at 30 days following the procedure.
“Patients at intermediate risk for open-heart surgery account for a large portion of the severe aortic stenosis population. We are delighted to take the self-expanding CoreValve Evo...
Source: Mass Device - July 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news
