Corindus Vascular Robotics (OTC:CVRS) said today it won FDA 510(k) clearance for its robotic-assisted CorPath System for use during percutaneous coronary interventions stenting procedures performed via radial access. The approval was based on results from a 30-patient clinical trial of the device that demonstrated a 100% device and clinical success rate, the Waltham, Mass.-based company said. “Radial […]
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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Cardiac Implants | Structural Heart | Pulsed-Field Ablation
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
TAVI: Study prompts FDA notice on blood clot risk
A small study published yesterday in the New England Journal of Medicine, finding reduced leaflet mobility in some replacement heart valves, prompted the FDA to caution doctors about the risk of blood clots on the devices. The finding is notable because it involves both transcatheter aortic heart implants and surgical aortic valve implants, which have been in […]
Medtronic closes TMVI developer Twelve Inc. buy
Medtronic (NYSE:MDT) said today it closed its $458 million purchase of transcatheter mitral valve replacement device developer Twelve Inc. Medtronic will pay $408 million for the developer and another $50 million pegged to CE Mark approval in the European Union for the Twelve TMVR device, the company said. “This acquisition supports Medtronic’s therapy innovation strategy, as […]
AtriCure picks up MIS cardiac company nContact
AtriCure (NSDQ:ATRC) said yesterday it bought cardiac-focused medical device developer nContact for approximately $99 million in shares of common stock and up front cash. The sale was funded with an upfront payment of approximately 3.7 million shares of AtriCure at $24.60 per share and $8 million in cash up front. The purchase also includes up to $50 million […]
Medtronic touts 5-year Valiant stent graft data
Medtronic (NYSE:MDT) today touted follow-up data from the Valor II study of its Valiant stent graft, saying patients with descending thoracic aortic aneurysms showed 94.8% freedom from aneurysm-related mortality at 5 years. Fridley, Minn.-based Medtronic, which originally won PMA approval for Valiant in April 2011, said the results show the durability of the Valiant device. The Valor II […]
FDA warns St. Jude Medical on CardioMEMS plant in Atlanta
UPDATED Oct. 6 with comment from St. Jude Medical. St. Jude Medical (NYSE:STJ) last week revealed that the FDA sent it a warning letter after inspections at the Atlanta plant where it makes its CardioMEMS implantable heart monitor turned up problems with its corrective and preventive action plans. Little Canada, Minn.-based St. Jude said Oct. 2 […]
FDA approves Boston Scientific’s Synergy absorbable stent
UPDATED Oct. 14, 2015, with comment from Boston Scientific’s Dr. Craig Thompson. The FDA approved Boston Scientific‘s (NYSE:BSX) Synergy drug-eluting stent for treating coronary artery disease, sending BSX shares up today and making BSX the 1st U.S. entrant on the next front in the stent wars. The Marlborough, Mass.-based company said the Synergy device’s bioabsorbable polymer is designed to dissolve completely after delivering […]
InspireMD pulls trigger on 10-for-1 reverse stock split
InspireMD (OTC:NSPR) said it pulled the trigger on a reverse 10-to-1 stock split with shareholders receiving 1 share of common stock for each 10 they own. The reverse split went into effect today for the Boston-based stent maker, according to a press release. In response, Inspire shares are down 11.8% to $1.45 in mid-day trading. The […]
Tryton Medical touts side branch stent study data
Tryton Medical said yesterday that data from a post hoc analysis of a randomized clinical trial of its Tryton side branch stent for patients with coronary bifurcation lesions showed reductions in target vessel failure and improved side branch diameter. Results from the study were published in the journal Catheterization and Cardiovascular Interventions. The 289-patient post-hoc analysis […]
Reva finishes CE trial enrollment for drug-eluting scaffold
Reva Medical (ASX:RVA) said it finished enrollment in its CE clinical trial of its Fantom siolimus-eluting bioresorbable scaffold for patients being treated for coronary artery disease. Data from the 110-patient Fantom II trial will be used for the company’s CE Mark application in the European Union, which the company said it is hopeful to submit in […]
Neuravi launches EmboTrap in Europe
Neuravi said today it launched its EmboTrap minimally invasive thrombectomy device for the treatment of acute ischemic stroke in Europe. The Embotrap device functions by capturing clots and allowing blood flow to resume immediately after the clot has been secured in patients who have experienced a stroke, CEO Eamon Brady told MassDevice.com in an interview in June. […]