Genesis MedTech announced today that it completed enrollment in its U.S. early feasibility study for its J-Valve transfemoral TAVR system. Developed by JC Medical, the U.S.-based Genesis subsidiary, J-Valve holds FDA breakthrough device designation. Its breakthrough designation covers the treatment of severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. Patients eligible for […]
Replacement Heart Valves
Edwards wins FDA approval for its Evoque replacement tricuspid valve
Edwards Lifesciences announced today that the FDA granted approval for its Evoque tricuspid valve replacement system. The company says this makes Evoque the first transcatheter therapy to receive an FDA nod to treat tricuspid regurgitation (TR). Irvine, California-based Edwards won CE mark for the Evoque system in October 2023. That approval also marked a first […]
CroíValve wins FDA IDE for tricuspid heart valve
CroíValve announced today that it began an early feasibility study for its Duo tricuspid coaptation valve system. The beginning of the study follows FDA investigational device (IDE) approval. Tandem II, a prospective, multi-center, non-randomized, single-arm study looks at the safety and performance of Duo in patients with severe or greater symptomatic tricuspid regurgitation (TR). Duo […]
FDA grants breakthrough nod for Pi-Cardia leaflet modification device for TAVR
Pi-Cardia announced today that the FDA granted breakthrough device designation for its ShortCut leaflet modification device. ShortCut facilitates valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction. Rehovot, Israel–based Pi-Carda earned the breakthrough nod after completing enrollment in a U.S. and European pivotal study last September. The leaflet modification system […]
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 […]
CardioMech raises $13M for transcatheter mitral chordal repair tech
CardioMech announced that it closed a $13 million financing round, bringing its total funding to $42 million to date. The Norway-based company is developing transfemoral, transeptally delivered mitral valve chordal repair technology in Fridley, Minnesota. Its latest round of funding came from existing and new investors, including an undisclosed strategic investor. CardioMech said in a […]
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 […]
Edwards plans to spin off critical care business next year
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 […]
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 […]