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. […]
Cardiac Implants
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 […]
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 […]
Biotronik announces 100,000th implant of ICDs with AFib monitoring
Biotronik announced today that it hit 100,000 implanted single-lead implantable cardioverter defibrillators (ICDs) with DX Technology. DX Technology enables direct atrial sensing for AFib detection and monitoring. Since its introduction in 2009, clinicians in more than 80 countries around the world have used DX ICDs. The technology offers reliable, timely information about atrial arrhythmias and […]
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 […]
Cardiac Dimensions has a new chief medical officer
Cardiac Dimensions announced today that it appointed Dr. Satya Shreenivas as its new chief medical officer (CMO). Kirkland, Washington-based Cardiac Dimensions develops minimally invasive treatments for heart failure with functional mitral regurgitation (FMR). That includes the Carillon Mitral Contour System, for which the company has the ongoing EMPOWER trial. Its new CMO served as an […]
The biggest stories from the 2024 J.P. Morgan Healthcare Conference
Some of the biggest names in medtech came together this week at the J.P. Morgan Healthcare Conference. They shared updates on financial progress, operational changes and new products, among other things. Medtronic shared details on plans to restore earnings power, while Abbott highlighted the success of its FreeStyle Libre system. Shockwave Medical outlined its plans […]
Orchestra BioMed begins pivotal trial of cardiac neuromod tech
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 […]