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tavr

Study supports Boston Scientific’s Acurate neo2 aortic valve system

June 8, 2022 By Sean Whooley

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Featured, News Well, Replacement Heart Valves, Structural Heart Tagged With: Boston Scientific, tavr

Boston Scientific’s Acurate Neo2 valve performs well in studies

May 20, 2022 By Sean Whooley

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Featured, Implants, News Well, Replacement Heart Valves, Structural Heart Tagged With: Boston Scientific, TAVI, tavr

Study shows strong performance, improved outcomes with Medtronic Evolut TAVR

May 18, 2022 By Sean Whooley

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Featured, News Well, Replacement Heart Valves, Structural Heart Tagged With: Medtronic, tavr

Medtronic enrolls first patient in trial of Evolut TAVR system in patients with aortic stenosis

May 2, 2022 By Sean Whooley

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, […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Featured, Replacement Heart Valves, Structural Heart Tagged With: Medtronic, tavr

FDA approves two clinical trials for HLT’s TAVR system

March 24, 2022 By Sean Whooley

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Featured, Implants, Replacement Heart Valves, Structural Heart Tagged With: HLT, tavr

Medtronic Evolut Pro TAVR wins approval in China

January 10, 2022 By Danielle Kirsh

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 […]

Filed Under: Cardiovascular, Regulatory/Compliance Tagged With: Medtronic, tavr

Abbott sees the delivery system as a differentiator for its TAVR

January 4, 2022 By Chris Newmarker

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 […]

Filed Under: Business/Financial News, Cardiovascular, Catheters, Featured, News Well, Replacement Heart Valves, Research & Development Tagged With: Abbott, tavr

FDA approves Edwards Lifesciences Sapien 3 with Alterra for pulmonary regurgitation

December 20, 2021 By Sean Whooley

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Replacement Heart Valves, Stents, Structural Heart Tagged With: Edwards Lifesciences, FDA, tavr

Sapien 3 TAVR offers improved outcomes, reduced cost, Edwards Lifesciences says

November 5, 2021 By Sean Whooley

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, […]

Filed Under: Cardiac Implants, Cardiovascular, Catheters, Clinical Trials, Featured, Replacement Heart Valves, Structural Heart Tagged With: Edwards Lifesciences, tavr

Medtronic touts 5-year study of self-expanding TAVR platform

November 5, 2021 By Sean Whooley

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Catheters, Clinical Trials, Featured, Replacement Heart Valves, Structural Heart Tagged With: Medtronic, tavr

Abbott enters U.S. TAVR market with FDA approval of its Portico with FlexNav

September 20, 2021 By Chris Newmarker

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 […]

Filed Under: Business/Financial News, Cardiovascular, Catheters, Featured, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance, Replacement Heart Valves, Structural Heart Tagged With: Abbott, tavr

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