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 […]
Structural Heart
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 […]
Procyrion raises $57.7M Series E for circulatory support device
Procyrion announced today that it completed a $57.7 million Series E funding round to support its Aortix device. Fannin Partners led the round, which included the conversion of $10 million in interim financing. New and existing family/multi-family office investors partnered with Fannin Partners in the financing. Returning investors, including BlueBird Ventures and an undisclosed strategic […]
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 […]
Medtronic, Rijnstate enroll first patient in aneurysm repair trial
Medtronic , with Rijnstate, announced today that they enrolled the first patient in the Hercules trial comparing abdominal aortic aneurysm repair methods. Hercules compares endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR). It looks at these methods in patients who have an abdominal aortic aneurysm (AAA) with a wide, infrarenal neck diameter. Abdominal aortic aneurysms […]
InspireMD wins CE mark for carotid stent system
InspireMD (Nasdaq:NSPR) announced today that it received CE mark approval for its CGuard embolic prevention carotid stent system (EPS). The Tel Aviv, Israel-based company designed CGuard for the prevention of stroke. It utilizes the company’s MicroNet technology for strong acute results and durable, stroke-free, long-term outcomes. InspireMD highlighted the importance of the transition to the […]