Edwards Lifesciences (NYSE:EW) said today that it won FDA approval for the use of its Sapien XT replacement heart valve in adult and pediatric patients with conditions affecting their pulmonary valves. The Sapien XT device is already approved in the U.S. for transcatheter aortic valve replacement in inoperable and high-risk patients with severe symptomatic stenosis and […]
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
Regenerative firm Creative Medical launches cardio-focused AngioStem biz
Regenerative biotech company Creative Medical Health said today it is launching a subsidiary biz, AngioStem, to commercialize its cardiovascular assets. Assets on hand for the newly launched company include a therapy that uses autologous and allogeneic adult stem cells in combination with modulation of oxidative stress to treat heart failure in patients with cardiovascular disease, […]
Stentys touts data from head-to-head stent trial against MDT’s Resolute
Stentys SA (EPA:STNT) today touted the results of its Apposition IV trial comparing the company’s Stentys self-apposing sirolimus-eluting coronary stent to Medtronic‘s (NYSE:MDT) Resolute stent in patients with ST-segment elevation myocardial infarction. Results from the study were published in the journal EuroIntervention this month. Stentys calls its suite of Apposition stents the “world’s 1st and only self-apposing […]
APN Health wins 510(k) for 3D cardiac mapping system
Electrophysiology tool developer APN Health said today it won FDA 510(k) clearance for its Navik 3D advanced cardiac mapping system. The system from Pleasanton, Calif.-based APN Health is designed to give operating electrophysiologists or cardiologists real-time 3D catheter locations using 2D fluoroscopic images correlated with the electrical activation of the heart to create 3D maps. “FDA […]
Abbott cautions on potential issue with MitraClip heart implant
Abbott (NYSE:ABT) warned surgeons earlier this month about a potential issue with its MitraClip after receiving 9 reports of problems that led to surgical interventions. In a Feb. 4 urgent field safety notice, Abbott Vascular said the reports indicated that the delivery system for the MitraClip device, which is designed to repair the heart’s mitral […]
Cook Medical expands beacon tip cath recall
Cook Medical expanded its Class I recall for beacon tip angiographic catheters to include additional lots, according to an FDA press release. Bloomington, Ind.-based Cook Medical’s Beacon Tip Angiographic Catheters are used to inject contrast die into blood vessels in the heart to prepare for cardiac angiograms used to diagnose heart conditions. The recall was initially filed […]
China’s JC Medical touts 1st TAVI implant outside the People’s Republic
Chinese device firm JC Medical said today that the 1st implantation of its J-Valve bioprosthesis transcatheter aortic valve implant was performed outside China in Vancouver, Canada. The patient in the operation suffered from heart failure due to severe aortic regurgitation and was considered high risk for open-heart aortic valve replacement surgery due to the condition. “The […]
HeartWare takes another hit despite Q4, 2015 beats
HeartWare International (NSDQ:HTWR) shares took another hit today despite 4th-quarter results that topped expectations on Wall Street, as investors reacted to lower-than-expected sales volume overseas. Fourth-quarter losses grew 1.1% to $-926,000, or -5¢ per share, for Framingham, Mass.-based HeartWare, which makes implantable heart pumps. Sales were off -7.0% to $68.1 million, compared with Q4 2014. […]
Reva pulls in $11.4m, updates on Fantom II trial enrollment
Reva Medical (ASX:RVA) this month gave an update on its Fantom II trial, which has reached its target enrollment of 110 patients for its 1st cohort, and announced an incoming $11.4 million through a sale of shares to Goldman Sachs International. The 110 patients make up the 1st cohort of the company’s trial investigating its Fantom […]
Cardiac Dimensions touts small Carillon mitral repair study
Cardiac Dimensions today touted the publication of a small study of its Carillon mitral valve repair system in the Journal of Invasive Cardiology, saying the device led to significant improvement in patients with functional mitral regurgitation. The percutaneous Carillon annuloplasty device is designed to use a distal anchor and proximal anchor, connected by a shaping ribbon, to reshape the […]
Medtronic claims title to world’s 1st app-based remote monitoring for pacemakers
Medtronic (NYSE:MDT) said today that its Canadian subsidiary won approval there for the world’s 1st app-based remote monitor for pacemakers, the MyCareLink Smart system. The Health Canada nod allows patients with compatible Medtronic pacers to use a smartphone or tablet to send data to caregivers, using a handheld portable device reader and the MyCareLink Smart app, the Fridley, Minn.-based […]