Abbott (NYSE:ABT) said today it won FDA approval for its HeartMate 3 left ventricular assist device, now approved as a destination therapy for patients with advanced heart failure. With the approval, the Chicago-based company said that the device can now be used in patients not eligible for a transplant as a life-long implant. “We partner with […]
Cardiac Dimensions wins German reimbursement for Carillon mitral repair device
Cardiac Dimensions said today that it won reimbursement from Germany’s Institute for the Hospital Remuneration System (InEK) for its Carillon mitral contour system intended to treat patients with functional mitral regurgitation. The Kirkland, Wash.-based company’s percutaneous Carillon device is designed to use a distal anchor and proximal anchor, connected by a shaping ribbon, to re-form the mitral […]
These 10 medtech companies care a lot about research
These 10 medical device companies spent the largest portion of their budgets on research and development. Here’s a look at what they produced. Each year, Medical Design & Outsourcing compiles a list of the top 100 medical device companies across the globe and ranks the companies based on annual revenue for the most recent fiscal […]
CryoLife gains on Q3 prelim beat
CryoLife Inc. (NYSE:CRY) shares ticked up today after it announced preliminary third-quarter sales numbers that beat the consensus forecast on Wall Street. Kennesaw, Ga.-based CryoLife said it expects to post sales of roughly $64.6 million, 4.5% ahead of The Street’s forecast for a $61.8 million top line. “Our third-quarter revenue results were driven by continuing […]
Neovasc touts Tiara TMVR success rate in study
A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation. Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study […]
Abiomed claims Impella pump not at fault in patient death
Update: Includes statement from Abiomed After reporting possible issues with two of its Impella heart pumps used in an open heart surgery, Abiomed (NSDQ:ABMD) said today that the devices were not to blame for the patient’s death. The Impella devices were used in a last-attempt effort to save an elderly patient undergoing open heart surgery, Abiomed CEO […]
FDA clears Transseptal Solutions’ TP Crosser transseptal access device
Medtech developer Transseptal Solutions said yesterday it won FDA 510(k) clearance for its TSP Crosser transseptal access system. The Israel-based company said that the TSP Crosser is an advanced transseptal puncture system which features a built-in steering mechanism and is designed for use in accessing the left atrium. The system is intended for use during […]
Report: Medtronic shuts down pacer programmer updates on hacking risk
Medtronic (NYSE:MDT) has disabled internet updates for approximately 34,000 CareLink devices designed for accessing and programming implanted pacemakers due to cybersecurity vulnerabilities with the systems, according to a Reuters report. The vulnerability, revealed this summer by cybersecurity firm researchers, could allow an outside agent to plant malware on the pacers that would allow them to […]
Cardialen raises $17m Series B
Cardialen said today that it closed a $17 million Series B round for the low-energy defibrillation technology it’s developing. The Minneapolis-based company said RiverVest Venture partners led the round, joined by Qiming Venture Partners, HBM Healthcare Investments and Cultivation Capital. The proceeds are earmarked for further clinical work on Cardialen’s “unpinning termination” therapy, which is designed to […]
Edwards launches US pivotal Centera self-expanding TAVR study
Edwards Lifesciences (NYSE:EW) said yesterday it launched a U.S.-based pivotal trial of its self-expanding Centera transcatheter aortic valve, exploring its use in treating severe symptomatic aortic stenosis in intermediate risk patients. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which […]
BD’s Bard reported to win third IVC bellwether
A federal jury in Arizona reportedly found for Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard today in a bellwether product liability case brought over its inferior vena cava filters. Although it’s the fourth bellwether case in the multi-district litigation over the IVC devices, which are designed to prevent blood clots from passing through the body’s […]
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