New registry data demonstrates positive hemodynamic performance and clinical outcomes with the Boston Scientific (NYSE:BSX) Acurate neo2 TAVI system. Dr. Andrea Scotti of the Montefiore Medical Center (New York) presented data on the current-generation aortic valve system at TVT: The Structural Heart Summit. It was simultaneously published in EuroIntervention. In an investigator-driven study, retrospective registry […]
tavr
Boston Scientific’s Acurate Neo2 valve performs well in studies
Boston Scientific (NYSE:BSX) announced positive outcomes from studies of its Acurate Neo2 aortic valve system. Initial outcomes from the Neo-Align study of 170 patients who underwent transcatheter aortic valve implantation (TAVI) with Acurate Neo2 using a novel implant technique to attempt commissural alignment of the prosthetic and native valves demonstrated that commissural alignment can be […]
Study shows strong performance, improved outcomes with Medtronic Evolut TAVR
Medtronic (NYSE:MDT) today announced positive results from a study of its Evolut transcatheter aortic valve replacement (TAVR) system. The Optimize PRO clinical study evaluated the self-expanding, supra-annular Evolut PRO and PRO+ TAVR platforms. Medtronic’s CoreValve Evolut R, CorValve Evolut PRO and Evolut Pro+ systems are indicated for the relief of aortic stenosis in patients with […]
Medtronic enrolls first patient in trial of Evolut TAVR system in patients with aortic stenosis
Medtronic (NYSE:MDT) announced today that it enrolled the first patient in its Expand TAVR II pivotal trial. Expand TAVR II will evaluate the self-expanding, supra-annular Evolut transcatheter aortic valve replacement (TAVR) platform in patients with moderate, symptomatic aortic stenosis (AS), a population outside of current guidelines and indications for TAVR. According to a news release, […]
FDA approves two clinical trials for HLT’s TAVR system
HLT announced today that it received FDA approval for two clinical studies for its HLT Meridian transcatheter aortic valve replacement (TAVR) system. Maple Grove, Minnesota-based HLT, a Bracco Group Company, will conduct the studies to assess the performance of the HLT Meridian TAVR system in treating aortic stenosis and aortic regurgitation among high-risk patients suffering […]
Medtronic Evolut Pro TAVR wins approval in China
Medtronic today announced that it received National Medical Products Administration approval in China for its CoreValve Evolut Pro TAVR system. The approval marks the first Medtronic TAVR system approved in China for patients with symptomatic severe aortic stenosis who are at high or extreme risk for open-heart surgery, according to the company. Medtronic’s approval of […]
Abbott sees the delivery system as a differentiator for its TAVR
A top Abbott executive explains how the company’s FlexNav delivery system could make the Portico TAVR competitive. Abbott is aiming to claw away market share from transcatheter aortic valve replacement pioneers Edwards Lifesciences and Medtronic. The Abbott Park, Illinois–based medtech company in September announced FDA approval of its Portico with FlexNav TAVR system, more than […]
FDA approves Edwards Lifesciences Sapien 3 with Alterra for pulmonary regurgitation
Edwards Lifesciences (NYSE:EW) announced today that it received FDA approval for the use of its Sapien 3 transcatheter valve with the Alterra adaptive prestent. Irvine, California-based Edwards garnered the FDA nod for use of the Sapien 3 with Alterra for patients with severe pulmonary regurgitation. The Sapien 3 transcatheter pulmonary valve (TPV) system combines the […]
Sapien 3 TAVR offers improved outcomes, reduced cost, Edwards Lifesciences says
Edwards Lifesciences (NYSE:EW) today touted a cost-effectiveness analysis that supports transcatheter aortic valve replacement (TAVR) with the Sapien 3. Irvine, California-based Edwards presented data from the Partner 3 trial during the late-breaking clinical trials at the 33rd Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation. According to a news release, […]
Medtronic touts 5-year study of self-expanding TAVR platform
Medtronic (NYSE:MDT) today presented five-year clinical data for its CoreValve and Evolut transcatheter aortic valve implantation (TAVI) platforms. Fridley, Minnesota-based Medtronic presented results from the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference. According to a news release, data from the trial demonstrated that the hemodynamic […]
Abbott enters U.S. TAVR market with FDA approval of its Portico with FlexNav
Abbott (NYSE:ABT) today announced U.S. FDA approval of its Portico with FlexNav TAVR system. The approval launches Abbott into a U.S. TAVR space that Edwards Lifesciences and Medtronic have dominated. (Check out our recent DeviceTalks Weekly podcast that recounted Edwards Lifesciences’ pioneering work in the space.) Boston Scientific is out of the TAVR market for […]
