BiVacor announced today that it received FDA breakthrough device designation for its Total Artificial Heart (TAH) system. The designation supports the TAH as a bridge to transplant (BTT) for adults with severe biventricular or univentricular heart failure where current treatments, including LVADs, are not viable. “This is more than a regulatory milestone. It’s a validation […]
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FDA greenlights expansion of BiVacor artificial heart study
BiVacor announced today that it completed the first phase of an FDA early feasibility study (EFS) for its Total Artificial Heart (TAH). Five patients received the BiVacor TAH between July and November 2024 in the study looking at the TAH as a bridge to donor heart transplant. The initial phase supported patients with the TAH […]
BiVacor reports first human implant of artificial heart
BiVacor recently announced the successful first-in-human implantation of its Total Artificial Heart (TAH) as part of an early feasibility study. Surgeons at Baylor St. Luke’s Medical Center in the Texas Medical Center completed the procedure on July 9. The first-in-human clinical study utilizing the TAH aims to evaluate the safety and performance of the system […]
BiVacor raises $13M to support artificial heart trial
BiVacor announced today that it brought in $13 million from the Australian government to support its Total Artificial Heart program. Australia’s Medical Research Future Fund (MRFF) provided a grant through its Artificial Heart Frontiers Program (AHFP). It aims to support the company’s TAH program and future product enhancements. BiVacor received FDA investigational device exemption to […]
BiVacor picks former BioVentrix CEO for its corner office
Artificial heart maker BiVacor announced today that it appointed Jim Dillon as its new CEO and as a member of its board. Dillon, an experienced medical device executive, most recently served as CEO of BioVentrix, a heart failure treatment developer. His appointment follows last week’s naming of Axonics CEO Raymond W. Cohen as board chair […]
Artificial heart maker BiVacor names Axonics CEO as chair of its board
BiVacor announced today that it appointed Axonics CEO Raymond W. Cohen as the new chair of its board of directors. Cohen serves as CEO and as a member of the board at Axonics, which develops sacral neuromodulation technologies. He originally founded Axonics in 2013 and took the Irvine, California-based company public in October 2018. The long-time […]
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 […]
BiVacor looks to implant its artificial heart in a person next year
BiVacor has raised $18 million to support the continued development of its preclinical artificial heart device. Cormorant Asset Management and OneVentures, through the OneVentures Healthcare Fund III, led the funding round, according to a March 29 news release from Houston-based BiVacor. The investments will fund the company’s continued research and development and early feasibility first […]
Artificial heart developer BiVacor taps former Abiomed exec as CEO
BiVacor this week announced that former Abiomed executive Thomas Vassiliades was appointed CEO, effective immediately. Prior to joining the company, Vassiliades was most recently the general manager of the surgery and heart failure business at Abiomed. He has also served as the chief medical officer of the coronary and structural heart business of Medtronic, and […]
What should the Mann Foundation do next?
Dr. Robert Greenberg, the Mann Foundation’s new executive chairman, has ideas about where to take one of medtech’s top research and development outfits. He explained more at DeviceTalks West in December. The new executive chairman of the Alfred E. Mann Foundation for Scientific Research sees the foundation continuing its mission of developing devices for unmet medical needs. The foundation […]
