Boston Scientific (NYSE:BSX) announced today that its ACURATE Prime XL Nested Registry completed patient enrollment. The registry evaluates the Acurate Prime aortic valve system, the Marlborough, Massachusetts-based company’s next-generation technology. It enhances the Acurate neo2 transcatheter aortic valve replacement (TAVR) system, including a full-sized matrix. The system treats patients with severe symptomatic aortic stenosis across […]
tavr
J&J’s Abiomed recalls Impella again — this time it’s TAVR-related
Johnson & Johnson’s Abiomed unit issued another recall for some of its Impella heart pumps. FDA communications dated July 14 confirmed the second recall in a month for certain Impella products. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from […]
Medtronic issues TAVR safety notice in Europe
Medtronic issued an urgent field safety notice for its replacement heart valve in Europe. The warning covers the Medtronic CoreValve Evolut Pro+ 34 mm transcatheter aortic valve replacement (TAVR). It’s dated December 2022, although it was published to a European regulatory site last week. Medtronic notified customers of a “known phenomenon” that occurs when the […]
Medtronic touts 3-year data for Evolut TAVR
Medtronic (NYSE:MDT) announced three-year data supporting its Evolut transcatheter aortic valve replacement (TAVR) system. Findings from the Evolut Low-Risk trial demonstrated numerically better clinical outcomes for the Evolut TAVR system. It also showed significantly better hemodynamic valve performance compared to surgical aortic valve replacement (SAVR). The study evaluated a low-risk aortic stenosis (AS) patient population. […]
Data backs durability of Medtronic CoreValve Evolut TAVR
Medtronic (NYSE:MDT) today announced five-year data that supports its CoreValve Evolut transcatheter aortic valve replacement (TAVR) implant. Dr. Steven Yakubov presented findings at the 2023 annual meeting of Cardiovascular Research Technologies (CRT 2023). The data showed significantly better valve performance and durability compared to surgical aortic valve replacement (SAVR). Medtronic’s study evaluated bioprosthetic valve dysfunction […]
Abbott wins FDA nod for its Navitor transcatheter aortic valve implant
Abbott (NYSE:ABT) announced today that it received FDA approval for its latest-generation transcatheter aortic valve implantation (TAVI) system. The company designed the Navitor system for treating people with severe aortic stenosis at high or extreme risk for open-heart surgery. It adds to Abbott’s transcatheter structural heart portfolio of less invasive treatment options for serious heart […]
Medtronic reports positive study results for next-gen Evolut FX TAVR system
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 […]
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 […]
