Abbott Vascular (NYSE:ABT) warned physicians about the slight risk that its MitraClip heart valve implant could be damaged if the device is misapplied during implantation.
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
Heart valves: St. Jude Medical champions Trifecta data
St. Jude Medical (NYSE:STJ) championed newly published results from the 4-year-old study it used to back its pre-market approval application for the Trifecta heart valve in The Journal of Thoracic and Cardiovascular Surgery.
FDA panel splits on Abbott’s MitraClip heart implant
FLASH: FDA panel votes 5-3 that benefits of Abbott’s MitraClip heart implant outweigh the risks
The FDA’s Circulatory System Devices Panel voted today to make its recommendation regarding Abbott’s (NYSE:ABT) premarket approval application for the MitraClip heart implant, agreeing unanimously that the device is safe but issuing a mixed result on the effectiveness and potential risks of the device.
Syncardia reels in $19M for artificial heart
Syncardia put together a $19 million financing package to back the spinout of its total artificial heart technology, hard on the heels of an FDA win for the device.
The bulk of the financing, $15 million, was doled out by New York-based funding group Athyrium Investors, with the balance coming from existing backers.
Cardiovascular Systems prices $33M offering | Wall Street Beat
Cardiovascular Systems (NSDQ:CSII) priced a public offering of some 2 million shares of CSII stock at $17.60 apiece, saying it expects to net about $33 million from the deal.
DC Devices lands $10.7M equity funding in support of transcatheter cardiac shunt
Massachusetts-based medical device startup DC Devices closed a $10.7 million funding round in support of its minimally invasive treatment for heart failure.
DC Devices "seeks to become the leading medical device company for the treatment of congestive heart failure," according to its page on the website of venture capital firm General Catalyst.
FDA says it won’t recommend approval for Abbott’s MitraClip implant
Correction: March 20, 2013, at 11:40 a.m.: This article mistakenly stated that the FDA’s advisory panel recommended against approval for MitraClip. The recommendation came from the FDA’s internal reviewers prior to the panel meeting.
Looking back on a pretty sedate ACC
Sometimes the major annual medical meetings are jam-packed with significant and market-moving data. And then sometimes they’re like this year’s American College of Cardiology conference, with relatively limited useful data from an investing perspective.
InspireMD wins CE Mark for MGuard blood clot stent
InspireMD (OTC:NSPR) said it won a nod from European regulators for its MGuard embolic protection stent, designed to prevent strokes after carotid artery stenting procedures.
The Tel-Aviv-based medical device company said the MGuard device is wrapped with its MicroNet mesh to prevent embolisms – blood clots – from occurring during and after the placement of a carotid stent.
CircuLite lands conditional FDA approval for tiny heart pump
Cardiovascular medical device maker CircuLite won conditional FDA approval for its flagship device, the Synergy circulatory support system. The company claims that this device, roughly the size of a AA battery, is the world’s smallest implantable heart pump.
The federal watchdog agency has granted conditional approval for Investigational Device Exemption (IDE) status. Synergy is an implanted device meant to halt symptoms for chronic heart patients by improving blood flow during a heart failure.