SS Innovations announced today that surgeons successfully performed a mitral valve replacement using its surgical robot. The procedure marks the world’s first mitral valve replacement using the company’s Mantra surgical robot. It took place at the Narayana Hrudayalaya Institute of Cardiac Sciences in Bengaluru, India. Dr. Nitin Kumar Rajput performed the surgery, guided by Dr. Sudhir […]
Cardiac Implants
Recall of Abbott HeartMate comms system is Class I
The FDA deemed a recall of the Abbott HeartMate Touch Communication System Class I, the most serious kind of recall. Abbott warned of the potential for its HeartMate Touch System to unexpectedly stop or start. This recall is a correction, not a product removal, according to the FDA. The company reported eight injuries and zero […]
Abbott reports data that backs TAVR, LAA systems
Abbott today reported positive study data supporting its first-generation transcatheter aortic valve system and its Amplatzer Amulet. Abbott reported its outcomes at the Cardiovascular Research Technologies (CRT) 2024 meeting. The company first reported a pooled analysis from three clinical studies evaluating its Portico TAVR system, the predecessor to Navitor. It showed the safety and effectiveness […]
Medtronic has positive Evolut TAVR data
Medtronic today reported two different datasets that support its Evolut transcatheter aortic valve replacement (TAVR) system. A cost-effectiveness analysis demonstrated the positive economic value of TAVR using Evolut in low-risk patients. It compared Evolut to surgical aortic valve replacement (SAVR). Then, Medtronic had contemporary data from its Evolut low-risk trial reinforcing long-term TAVR outcomes compared […]
Endotronix has positive pulmonary artery sensor data
Endotronix announced positive six-month results from a pivotal trial evaluating its Cordella pulmonary artery (PA) sensor. Naperville, Illinois-based Endotronix designed Cordella to enable proactive, data-driven heart failure (HF) management. It aims to engage patients, reduce and prevent congestion and improve outcomes. The PROACTIVE-HF trial evaluates Cordella in NYHA Class III HF patients at risk of […]
Affluent Medical has positive biomimetic mitral valve data
Affluent Medical today announced positive findings in a clinical evaluation of its Epygon device for replacing mitral valves. The Aix-en-Provence, France-based company designed Epygon to replace mitral valves in those with mitral insufficiency. Epygon is the first biomimetic transcatheter mitral valve to mimic the native mitral valve and restore the natural vortex of blood flow […]
J&J’s Biosense Webster begins trial for Laminar left atrial appendage elimination device
Johnson & Johnson’s Biosense Webster today announced the start of patient cases with the investigational Laminar LAAX system. In November 2023, Johnson & Johnson MedTech completed a $400 million acquisition of Laminar, With that buy, the company brought in Laminar’s left atrial appendage elimination (LAAX) technology. Unlike other LAA technologies, which exclude or occlude the […]
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 […]
AtriCure grows sales by 21% in Q4
AtriCure shares dipped today despite fourth-quarter results that came in ahead of the consensus forecast. Shares of ATRC fell 2.8% at $33.25 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 0.7%. The Mason, Ohio-based company posted losses of $9.8 million. That […]
Impulse Dynamics raises $136M for heart failure therapy
Impulse Dynamics announced today that it raised $136 million in financing to accelerate its investment in its heart failure therapy. Perceptive Advisors, Redmile Group, Alger and Hobart Healthcare led the financing round. The company expects it to accelerate investment in global commercialization, technology, product innovation and clinical evidence development. Marlton, New Jersey–based Impulse Dynamics plans […]
FDA panel votes in favor of Abbott TriClip TEER system for treating tricuspid regurgitation
Abbott announced today that an FDA advisory committee ruled that the benefits of its TriClip outweigh the risks in treating tricuspid regurgitation (TR). The Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA confirmed this with votes registering 13 to 1 in favor of TriClip’s benefits. Abbott submitted TriClip, a transcatheter […]