Advanced Cardiac Therapeutics said yesterday the 1st 12 patients have been treated using its open-irrigated radio frequency ablation technology to treat atrial fibrillation. The treatments were performed in Prague by study principal investigator Dr. Vivek Reddy of Mt. Sinai Hospital, the company said. ACT’s RF tech incorporates a generator with a novel temperature-sensing low-flow catheter […]
Cardiovascular
Welcome to MassDevice's Cardiovascular Hub, your resource for the latest news in cardiac implants, structural heart, heart valves, stents and more. Stay informed about the innovations and business news shaping the cardiovascular device industry.
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Here are top cardiology features from MassDevice and its sister publications (and scroll down to read the latest cardiology device news from MassDevice):
+ LVADs save lives: So why aren’t more available?
+ How Medtronic uses nitinol to improve the structure and effectiveness of heart devices
+ How Abbott designed the world’s first dual-chamber leadless pacemaker system
+ J&J used RWE for expanded indications — and you can, too
+ 7 cardiology startups you need to know
Latest Cardiology News
Brainlab invests nearly $8m into Jan Medical
Jan Medical said today it obtained $7.5 million in Series C funding from partner Brainlab Inc, with funds slated to aid in completion of a clinical trial and filing for de novo clearance with the FDA and CE Mark approval in the European Union for its BrainPulse tool. Mountain View, Calif.-based Jan Medical’s BrainPulse device is designed to […]
FDA: St. Jude Medical’s Optisure recall is Class I
The FDA termed a recall by St. Jude Medical (NYSE:STJ) of a small number of its Optisure defibrillator leads as Class I, denoting the risk of serious injury or death. Little Canada, Minn.-based St. Jude notified physicians in a Nov. 3, 2015, letter that a technique used to strip adhesive from the Optisure’s superior vena cava shock […]
CryoLife closes $130m On-X Technologies buyout
CryoLife Inc. (NYSE:CRY) said yesterday that it closed its play for the mechanical heart valve space, the $130 million acquisition of On-X Life Technologies. On-X makes an aortic valve replacement and is developing a mitral chord repair device called Chord-X. The Austin, Texas-based company put up sales of about $33 million last year. The deal called for […]
AtriCure wins Japanese regulatory nod for AtriClip
AtriCure (NSDQ:ATRC) said today it won approval from the Japanese Ministry of Health, Labor and Welfare for its AtriClip line of products designed for the occlusion of the left atrial appendage. The approval was achieved through the aid of the company’s Japanese distributor Century Medical Inc, the West Chester, Ohio-based company said. “We are excited to […]
FDA clears LifeWatch patch for remote cardiac monitoring
LifeWatch (SWX:LIFE) said yesterday that it won 510(k) clearance from the FDA for its mobile cardiac telemetry patch, a 1-lead electrocardiograph system. Zug, Switzerland-based LifeWatch said the MCT 1-lead patch is capable of “watching every heartbeat for adverse cardiac events and transmitting significant findings, in near-real time, to a clinical service center.” “I am very excited about […]
FDA sets panel date for Angel Medical’s implantable cardiac monitor
The FDA is slated to convene an advisory panel meeting to discuss Angel Medical Systems’s pre-market approval application for the AngelMed Guardian implantable heart monitor, the agency said today. The FDA’s Circulatory System Devices Panel is due to meet March 16 to discuss the PMA for the AngelMed Guardian, which is designed to detect the early heart problems […]
Abbott wins FDA panel date for Absorb GT1 bioabsorbable stent
The FDA said today that 1 of its advisory panels is due to convene for a hearing on the Absorb GT1 bioabsorbable stent developed by Abbott (NYSE:ABT). The federal safety watchdog’s Circulatory System Devices Panel is slated to meet March 15 for a vote on Abbott’s pre-market approval for the Absorb GT1 device, a coronary scaffold that’s […]
Prospects for proxy war heat up at HeartWare
HeartWare International (NSDQ:HTWR) is facing another potential proxy battle after a 2nd activist investor firm took out a stake in the implantable heart pump maker. Last month Engaged Capital, which owns about 1.3% of Framingham, Mass.-based HeartWare, said it’s prepared to launch a proxy war over the proposed acquisition of Israeli replacement heart valve maker Valtech Cardio. Engaged […]
Edwards Lifesciences wins FDA nod for new Sapien 3 trial
Edwards Lifesciences (NYSE:EW) said today that the FDA approved a new trial of its Sapien 3 replacement heart valve. The Sapien 3 transcatheter aortic valve replacement was approved last year by the federal safety watchdog for patients at high risk of death from open surgical procedures to replace their aortic valve. The new investigational device exemption […]
Imricor wins CE Mark for MR-conditional recording system
Imricor Medical Systems said today it won CE Mark approval in the European Union for its Advantage-MR EP recorder/stimulator system, designed to allow for MRI-guided electrophysiology procedures. The system, along with MR-compatible ablation catheters, will allow operating physicians to perform cardiac ablations using real-time MRI guidance, which the Minneapolis, Minn.-based company said could improve safety […]