Medtronic (NYSE:MDT) today presented positive results for its next-generation transcatheter aortic valve replacement (TAVR) system. The study compared the next-generation Evolut FX TAVR systems to earlier-generation Evolut systems. Data demonstrated significantly improved commissure alignment during TAVR procedures with Evolut FX. A late-breaking presentation at PCR London Valves 2022 summarized the early limited market release of […]
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Data backs Boston Scientific Acurate neo2 aortic valve
Boston Scientific (NYSE:BSX) announced positive results from its post-market clinical follow-up study for the Acurate neo2 aortic valve system. Marlborough, Massachusetts-based Boston Scientific’s findings included a high procedural success rate of 98.4% for the TAVR system. In addition, the study observed low rates of mortality and paravalvular leak (PVL). Findings, presented at PCR London Valves […]
4 major cardiology trends you need to know from TCT 2022
Medtronic, Edwards and Abbott presented positive data as TAVR, TEER and renal denervation innovations continue to arrive. The 34th Transcatheter Cardiovascular Therapeutics (TCT) conference took place in Boston this past week and a ton of big names made waves with their technologies and innovations. Medtronic, Abbott, Edwards and Boston Scientific represent a few of the […]
Medtronic presents positive data on TAVR, TMVR devices
Medtronic (NYSE:MDT) announced data from multiple trials supporting its transcatheter heart valve replacement devices. Data were presented at the 34th Transcatheter Cardiovascular Therapeutics (TCT) conference in Boston. Results covered the company’s self-expanding transcatheter aortic valve replacement (TAVR) devices and its transapical transcatheter mitral valve replacement (TMVR) system. Medtronic kicked off TCT by announcing the full […]
Medtronic fully launches its next-gen TAVR in U.S.
Medtronic (NYSE: MDT) marked the start of the TCT 2022 conference today by announcing the full U.S. launch of its Evolut FX TAVR system. The medtech giant’s next-generation TAVR won FDA approval in 2021, followed by a limited roll out earlier this year. Edwards Lifesciences —Medtronic’s major U.S. competitor in the transcatheter aortic valve replacement […]
JenaValve completes enrollment in TAVR trial
JenaValve announced today that it successfully completed patient enrollment in a trial evaluating its Trilogy heart valve system. Irvine, California-based JenaValve develops and manufactures differentiated transcatheter aortic valve replacement (TAVR) systems. It designed Trilogy for high surgical risk patients with symptomatic, severe aortic regurgitation (AR). JenaValve’s prospective, single-arm ALIGN-AR trial is operating under FDA investigational […]
Study supports Boston Scientific’s Acurate neo2 aortic valve system
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 […]
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 […]