Anteris Technologies Ltd. presented multiple sessions at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 annual meeting in San Francisco this week on its novel Duravr biomimetic heart valve, a balloon-expandable, single-piece transcatheter aortic valve designed to closely replicate the shape and performance of a human aortic valve. The device was used for the first time earlier this year in a valve-in-valve replacement procedure and began its early feasibility study, both of which were reviewed at the cardiology meeting.
The annual volume of implant of transcatheter aortic valve replacement (TAVR) devices has grown steadily over the years, and that volume might sustain its upward trajectory over the next few years if the results of a new analysis of more than 46,000 TAVR patients gain traction. The data for these patients with minimally symptomatic aortic stenosis (AS) predictably indicated that this group was less susceptible to bad outcomes than those with more severe symptoms, but one of the hopes is that earlier intervention into AS could ward off future cardiovascular events, a finding which might justify expanded payer coverage for TAVR in these patient populations.
Two research studies by Egnite Inc. presented at the American College of Cardiology Conference (ACC) could shake up the scope of how aortic stenosis (AS) is understood and treated by physicians.
Device durability for transcatheter aortic valve replacement (TAVR) devices remains topical for patients, payers and regulators, but the standard measure of 10-year data were difficult to obtain for the first decade after the FDA first approved a TAVR device in 2011.
Anteris Technologies Ltd. raised AU$35 million (US$24.21 million) to fund clinical development of its 3D single-piece prosthetic heart valve implant, the Duravr, for the treatment of aortic stenosis.
Transcatheter aortic valve replacement (TAVR) continues to grow, so it is little surprise that the 2022 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting featured multiple presentations about TAVR-related devices and outcomes. The American College of Cardiology/American Heart Association’s latest guidelines recommends TAVR for patients over age 80 and surgery for those under age 65. Those in the middle can go either way, depending on comorbidities and patient preferences.
There is a lack of biomarkers for disease activity in aortic stenosis (AS). On the other hand, citrullination is involved in many chronic inflammatory processes and citrullinated proteins have been found within atherosclerotic plaque.
There may be those who believe that artificial intelligence (AI) is suffering from overexposure in the media, but these software algorithms are nonetheless challenging medical professionals in their use of medical diagnostics. A new study showed that an AI algorithm not only bested the sonographer in interpretation of whether cardiac ultrasound was indicative of left ventricular ejection fraction (LVEF), but also that the results were sufficiently vigorous that the reviewing cardiologist couldn’t distinguish between the sonographer’s interpretations and those provided by the algorithm.
The FDA has given thumbs up to two clinical studies for a transcatheter aortic valve replacement (TAVR) system developed by HLT Inc. to treat aortic stenosis among high-risk patients. Those studies will include aortic regurgitation which also occurs when an aortic valve doesn't open and close tightly enough but for which there are few suitable, noninvasive treatments.
Peijia Medical Ltd. has acquired exclusive rights to Jenavalve Technology Inc.’s transcatheter aortic valve replacement (TAVR) products for the treatment of aortic regurgitation (AR) and aortic stenosis (AS). Suzhou, China-based Peijia is now able to develop, manufacture, and commercialize the TAVR products in Greater China.
