HeartWare International (NSDQ:HTWR) said today it completed enrollment of its Endurance 2 destination therapy trial of its HeartWare ventricular assist system. The trial seeks to examine the rate of stroke in patients treated with HeartWare’s HVAD device as well as optimal blood pressure management, the company said. Data from the 465-patient supplemental cohort trial will be […]
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
Glaukos iStent wins nod from Health Canada
Glaukos (NYSE:GKOS) said today it won approval from Health Canada for its iStent Inject trabecular micro-bypass stent designed for use in cataract surgeries to treat glaucoma. The newly cleared iStent inject is indicated for micro-invasive glaucoma surgery procedures to reduce intraocular pressure in patients with primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma, the Laguna Hills, […]
JenaValve closes $27m Series C round
JenaValve Technology said today that it closed a $26.5 million Series C round for the replacement heart valve it’s developing. Irvine, Calif.-based JenaValve said the round was co-led by RMM (Rudi Mariën) and Valiance and included existing backers Atlas Venture, Edmond de Rothschild Investment Partners, Gimv, Legend Capital, NeoMed Management and VI Partners. The proceeds are earmarked […]
Neovasc squeaks by Q2, positive on Tiara trial
Neovasc (NASDAQ:NVCN) reported 2nd quarter sales ahead of estimates, though down from 2014 and marked by growing losses, but rallied around the progress of its Tiara transcatheter mitral valve implant feasibility trial. The company’s 30-patient Tiara 1 trial has 2 study patients implanted, in addition to 5 patients implanted through compassionate use regulations. Of the 3 compassionate […]
Medtronic recalls some EnVeo R TAVI loading systems
UPDATED August 7, 2015, with comment from Medtronic. Medtronic (NYSE:MDT) is recalling some 6,900 EnVeo R loading systems for its CoreValve Evolut R replacement heart valve, after particulate matter turned up in some lots. The FDA gave the 6,912-unit recall Class I status, denoting a problem that could lead to serious injury or death. Fridley, Minn.-based […]
PAD: Medtronic launches Entrust delivery device
Medtronic (NYSE:MDT) said today it launched the Entrust delivery system in the U.S., designed to work with the company’s EverFlex self-expanding peripheral stent for treating peripheral arterial disease. The system allows operating physicians to maintain a low profile while deploying the stent to re-open stenotic regions in the superficial femoral and proximal popliteal arteries that supply blood […]
FDA warns on potential LVAD issues
The FDA published a safety communication today warning about issues with implantable left ventricular assist devices. The federal watchdog referenced specific issues with both approved implantable LVADs: Thoratec’s HeartMate II and HeartWare’s HVAD system. Adverse events referenced included increased rate of pump thrombosis with the HeartMate II and a high rate of stroke with HeartWare’s […]
Sorin’s Perceval heart valve wins Health Canada nod
Sorin Group (BIT:SRN) said today that it won approval from Health Canada for its Perceval sutureless aortic valve replacement. The valve, which is designed to hold itself in place with a self-anchoring frame, is under review at the FDA now that Sorin has a U.S. investigational device exemption trial under its belt, the company said. “Sorin is […]
Boston Scientific inks deal with Preventice
Boston Scientific (NYSE:BSX) said yesterday it inked a sales and marketing deal with cardio-focused remote patient care company Preventice Solutions. The new deal will position medical device giant Boston Scientific as Preventice’s exclusive sales and marketing representative for its cardiology-related diagnostic and monitoring offerings, the companies said. “This agreement marks an important strategic milestone for Preventice Solutions. […]
Sorin claims its new CRT-P is the world’s smallest
Sorin Group (BIT:SRN) said today it launched its Reply CRT-P cardiac resynchronization therapy pacemaker, claiming it to be the world’s smallest of its kind. The Reply CRT-P is 11.3 cc in volume, 3.7 cc smaller than Boston Scientific‘s (NYSE:BSX) Intua and 0.2 cc smaller than St. Jude Medical‘s (NYSE:STJ) Anthem CRT-P, according to their respective sites. The […]
Sorin’s Q2 earnings plunge on Cyberonics merger costs
Sorin Group (BIT:SRN) said yesterday that its 2nd-quarter profits plunged nearly 80% , largely due to costs from its pending, $2.7 billion merger with Cyberonics (NSDQ:CYBX). Milan-based Sorin said profits were €2.1 million ($2.3 million), down -79.0% from €10.0 million ($11.1 million) during Q2 2014. The merger with Cyberonics into a new entity called LivaNova cost €16.6 million ($18.4 […]