Meril Life Sciences Pvt Ltd. recently launched its next generation transcatheter heart valve (THV), the Myval Octapro THV, which it says allows for better operator control for precise positioning and improved predictability in implantation. The new valve comes however, as the company battles with Edwards Lifesciences Corp. in a European court over patent infringement of its technology.
Although there is a clear clinical need for transcatheter mitral valve replacement technologies, a number of challenges must be overcome before they can safely be used to treat patients with mitral regurgitation. Nevertheless, two new devices could enter the European market next year, Edwards Lifesciences Corp.’s Sapien M3 and Highlife Medical SAS’s Highlife TMVR device.
Edwards Lifesciences Corp. revealed excellent one-year data highlighting the performance of its newest generation Sapien 3 Ultra Resilia valve. Patients treated with the transcatheter aortic valve replacement system experienced lower rates of mortality and reintervention compared to its predecessors.
Two recent trials in cardiovascular disease took critical steps toward addressing ongoing and deadly disparities in cardiac care by focusing entirely on women.
The first year of data from the TRISCEND II study of the Evoque tricuspid valve by Edwards Lifesciences Corp. confirm the notion that reduced regurgitation has a big impact on patient well-being. While one-year data support the device’s safety, cardiovascular mortality at one year does not seem to decisively favor the device over medical management.
The ACURATE study of the Accurate neo2 TAVR device by Boston Scientific Corp., failed to demonstrate the device is non-inferior to established devices, but the COVID-19 pandemic threw up some roadblocks.
Some studies suggest a need for cardiologists to rethink their approach to device implant. However, the TAVR UNLOAD study failed to demonstrate a statistically significant difference between device implant and medical management for patients with aortic stenosis and low left ventricular ejection fraction.
Transcatheter aortic valve replacement (TAVR) devices continue to make a splash in the world of medical technology, with the Sapien 3 by Edwards Lifesciences Corp. leading the way. Results of the EARLY TAVR study strongly suggest a need for implant in asymptomatic patients with severe aortic stenosis, a development that should help sustain and possibly increase sales of these devices for the next few years.
This is a very exciting time for med-tech in Europe despite companies facing regulatory and funding challenges, Todd Brinton, corporate vice president, advanced technology, and chief scientific officer at Edwards Lifesciences Corp. told BioWorld.
In the first study to compare transcatheter aortic valve replacement or implantation to surgical aortic valve replacement exclusively in women, Edwards Lifescience Corp.’s Sapien 3 and Sapien 3 Ultra valves provided better outcomes.
