Edwards Lifesciences announced today that it intends to spin off its critical care business by the end of 2024. The company shared a number of key plans going forward as it outlined its plans for future growth. Among its plans, Edwards expects to spin off the critical care unit and its full range of smart […]
Replacement Heart Valves
ReValve reports successful first-in-human implant of next-gen TMVR
ReValve Solutions announced today that doctors successfully treated the first patient with its next-generation replacement heart valve. Cardiologists at the Punta Pacifica Hospital, Panama City, Panama, performed the procedure. An 81-year-old male with a history of heart failure received the Palmetto transcatheter mitral valve replacement (TMVR). The patient also had a series of failed surgical […]
BiVacor wins FDA IDE for first-in-human artificial heart study
BiVacor announced today that the FDA granted investigational device exemption (IDE) for its total artificial heart (BTAH). IDE approval allows BiVacor to begin its first-in-human early feasibility study (EFS) for the BTAH system. The Houston-based company aims to evaluate BTAH’s safety and feasibility as a bridge to a heart transplant for patients with biventricular heart […]
Teleflex enrolls first patient in registry of vascular closure device for TAVR
Teleflex announced today that it enrolled the first patient in a clinical registry evaluating its Manta vascular closure device (VCD). The company aims for the registry to examine and collect data on outcomes of contemporary on-label use of Manta in standard of care transcatheter aortic valve replacement (TAVR) procedures. It includes appropriate patient selection and […]
Xenter unveils new dual-sensor guidewire for TAVR procedures
Xenter today announced the recent unveiling of its dual-sensor investigational guidewire for transcatheter aortic valve replacement (TAVR). Draper, Utah-based Xenter shared the technology at last month’s Transcatheter Cardiovascular Therapeutics (TCT) 2023 conference in San Francisco. The first-of-its-kind wireless guidewire aims to collect an extensive range of real-time data points. It serves as an aortic regurgitation […]
The biggest cardiovascular stories from TCT 2023
Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT. This year’s 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco. Usual suspects like Medtronic and Abbott released data covering a range of products, while other big names like Edwards, GE […]
Edwards wins CE mark for Mitris Resilia valve
Edwards Lifesciences announced today that it received CE mark approval for its Mitris Resilia tissue valve replacement. News of the latest regulatory milestone follows the receipt of CE mark approval for the Evoque valve system last week. Edwards also reported positive TAVR data at TCT 2023 and recorded third-quarter sales growth in its latest earnings […]
5-year data supports Edwards Lifesciences’ Sapien 3 TAVR
Edwards Lifesciences announced new data demonstrating continued positive outcomes with its Sapien 3 transcatheter aortic valve replacement (TAVR). Results from the PARTNER 3 trial showed continued low rates of all-cause mortality, disabling stroke and rehospitalization at five years. Edwards presented the data at the 35th Transcatheter Cardiovascular Therapeutics (TCT) in San Francisco. It simultaneously published […]
Medtronic Evolut TAVR outperforms surgical valve replacement in study
Medtronic today announced positive four-year results from a trial of its Evolut transcatheter aortic valve replacement (TAVR) system. Evolut TAVR demonstrated “exceptional outcomes and sustained valve performance,” Medtronic says. It showed significantly better hemodynamics than surgical aortic valve replacement (SAVR). The company presented the data at the 35th Transcatheter Cardiovascular Therapeutics (TCT) conference in San […]
Slow and steady wins the race: JenaValve aims to offer new option for aortic regurgitation patients
The Munich-based startup JenaValve is a bit like the tortoise, with a slow and steady approach to transcatheter aortic valve replacement (TAVR) device development. At the Transcatheter Cardiovascular Therapeutics (TCT) conference today, Dr. Vinod Thourani, co-principal investigator of the ALIGN-AR study, jokingly compared the company’s approach to a “nice bottle of wine” that gets better […]
Medtronic has positive Intrepid TMVR data
Medtronic shared positive data from a study of its Intrepid transcatheter mitral valve replacement (TMVR). The medtech giant presented one-year results from the Intrepid early feasibility study at TCT 2023. It simultaneously published the data in JACC: Cardiovascular Intervention. Medtronic says the study demonstrated the early benefits of the Intrepid TMVR-transfemoral system, maintained up to […]