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 […]
Cardiac Implants
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 […]
Canary Medical has first-in-human implant of heart sound monitor
Canary Medical announced today that it completed the first-in-human limited feasibility trial of its cardiac auscultation monitoring device. Vancouver, British Columbia–based Canary is developing the device as a first-in-class implantable sensor. It provides daily adjunctive objective cardiac parameter measurements. The company believes it could enable patients and clinicians to better manage congestive heart failure symptoms. […]
Medtronic touts cost-effectiveness of Linq insertable cardiac monitors
Medtronic today announced new cost-effectiveness data from a study looking at its Reveal Linq insertable cardiac monitor (ICM). Results from the STROKE AF clinical study demonstrated that continuous monitoring with Reveal Linq proved significantly more cost-effective than the standard of care in ischemic stroke patients with large artery and small vessel disease. Medtronic plans to […]
TAVR, Critical Care drive Edwards to Q4 sales beat
Edwards Lifesciences shares dipped slightly today on fourth-quarter results that topped the consensus sales forecast. Shares of EW fell 0.2% to $88.11 in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.3%. The Irvine, California-based company posted profits of $369.9 million. That equals […]
Genesis MedTech completes enrollment in TAVR trial
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 […]