Orchestra BioMed (Nasdaq:OBIO) announced today that it randomized the first patient in a clinical trial of its AVIM therapy. The company’s BackBeat CNT atrioventricular interval modulation (AVIM) therapy treats pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications. New Hope, Pennsylvania-based Orchestra Biomed’s BACKBEAT pivotal study evaluates the efficacy and safety of AVIM […]
Cardiac Implants
Endotronix submits pulmonary artery sensor for FDA premarket approval
Endotronix announced today that it submitted a premarket approval (PMA) application to the FDA for its Cordella system. Cordella, a pulmonary artery (PA) sensor system, enables proactive, data-driven heart failure (HF) management. It engages patients, reduces and prevents congestion and improves outcomes. The Cordella system delivers proactive PA pressure data and non-invasive vital health data […]
Medtronic wins CE mark for next-gen Micra leadless pacemakers
Medtronic announced today that it received CE mark approval for its next-generation Micra AV2 and Micra VR2 miniature, leadless pacemakers. CE mark follows FDA approval for both devices in May of last year. The pacemakers — which Medtronic labels as the world’s smallest — provide longer battery life and easier programming than earlier versions. Micra […]
AtriCure adds J&J veteran to its board
AtriCure (Nasdaq:ATRC) announced today that it appointed longtime Johnson & Johnson executive Shlomi Nachman to its board of directors. Nachman most recently served as company group chair within the Johnson & Johnson Medical Devices (now MedTech) business. He also joined the board of transcatheter aortic valve replacement technology developer JenaValve in September. “I am thrilled […]
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 […]
Elutia submits drug-eluting biomatrix for use with cardiac implants to FDA
Elutia (Nasdaq:ELUT) announced today that it submitted a 510(k) premarket notification to the FDA for its drug-eluting biomatrix. The company designed its next-generation CanGarooRM for use with cardiac implantable electronic devices like pacemakers and defibrillators. A bioenvelope, CanGarooRM stabilizes the implantable devices. Made from a natural biomaterial that promotes a regenerative healing response, the biomatrix […]
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 […]