HeartWare International (NSDQ:HTWR) issued a field notice on its HVAD implantable heart pump over issues with worn alignment guides and connection pins that could lead to the pump stopping, according to the FDA. The FDA labeled it a Class I recall, the most serious type of recall issued by the federal watch dog, indicating that “there is […]
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
New Watchman study reports positive data
New data from a study of Boston Scientific (NYSE:BSX)’s Watchman left atrial appendage closure device reports positive results in a study comparing it to warfarin, an anticoagulant drug treatment, in patients with nonvalvular atrial fibrillation. The 2,406-patient study, published in the Journal of the American College of Cardiology, reported a lower rate of hemorrhagic strokes, unexplained and cardiovascular […]
Sorin, Cyberonics announce new slate for post-merger board
Sorin Group (BIT:SRN) and Cyberonics (NSDQ:CYBX) yesterday announced a new slate for the board of directors that will oversee the company after the expected close of their $1.4 billion merger in the 3rd quarter. Last month the companies announced the management roster for the new entity, which is slated to unite global leaders in neuromodulation and cardiac surgery with […]
Medtronic launches Fortrex PTA balloon catheter in US
Medtronic (NYSE:MDT) said yesterday that it launched its Fortrex percutaneous transluminal angioplasty balloon catheter in the U.S. The Fortrex is designed to treat peripheral artery disease and maintain arteriovenous access for hemodialysis, the Fridley, Minn.-based company said. The catheter uses a balloon to break up plaque blockages in the peripheral vascular system, or blockages in hemodialysis […]
Cordis releases expanded range of CTO treatment catheters
Cordis Corporation said Monday it is releasing an expanded line of catheters designed to treat and cross chronic total occlusions. The previous Johnson & Johnson (NYSE:JNJ) subsidiary, recently sold to Cardinal Health (NYSE:CAH) said it will bring the Outback Elite re-entry catheter to the U.S., Japan and Europe, and the Elitecross Support catheter to the U.S. “New and […]
Bard’s Lutonix DCB receives improved Medicare reimbursements
C.R. Bard (NYSE:BCR) said today that the U.S. Centers for Medicare and Medicaid Services has improved the payment for Bard’s Lutonix drug-coated balloon catheter through the Medicare hospital outpatient prospective payment system. The Murray Hill, N.J.-based company said that Medicare will now reimburse the full cost of its DCB device for percutaneous transluminal angioplasty, stenting, […]
HeartWare warns on HVAD issues
HeartWare International (NSDQ:HTWR) said today it issued a voluntary urgent medical device correction last month describing 5 complaints about its HVAD implantable heart pump. The 1st issue involves a possible degradation of the HVAD’s internal battery, causing a loss of a “double disconnect alarm” if both power sources that connect to the pump are disconnected, the report said. […]
TAVI: St. Jude Medical can resume Portico trial
St. Jude Medical (NYSE:STJ), which paused implantations of its Portico replacement heart valve last fall out of an abundance of caution, won the FDA’s approval to resume U.S. implants of the device in a clinical trial, the company said yesterday. Back in September 2014, St. Jude said CT scans turned up a potential problem with the Portico valves in […]
Positive early data for Valtech’s Cardioband
A trial of Valtech Cardio‘s Cardioband transcatheter annuloplasty system showed no device-related mortality, with decreases in mitral regurgitation and septo-lateral dimension. Results from the 40-patient multicenter observational study, designed to evaluate the safety and performance of the Cardioband, were presented this week at the European Society of Cardiology’s annual meeting in Paris. The study was […]
Carmat to give 4th patient artificial heart within 3 months
(Reuters) — Carmat (FRA:CXT) will equip a 4th patient with an artificial heart within 3 months at most, 1 of the company’s founders told BFM television today. The French company is conducting trials of its heart device, which is designed as a permanent implant to extend the life of patients without them having to wait for a […]
TAVI: Good early data for Keystone Heart’s TriGuard
Data from a trial of Keystone Heart‘s TriGuard anti-stroke device showed a lower rate of neurologic deficits after transcatheter aortic valve implantation, according to research presented last month at EuroPCR 2015 in Paris. The 85-patient Deflect 3 study found that TAVI patients treated with the Israeli company’s TriGuard, which is designed to allow blood to […]