InspireMD (OTC:NSPR) said Wednesday it won European Union regulatory approval, including CE Mark approval, for the manufacturing and commercialization of its CGuard stent delivery catheter. The approval also allows InspireMD to add-on manufacturing facilities for the device to enable more efficient work flow, the Boston-based company said. “We are pleased to receive Dekra certification for our […]
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
Report: TMVR at least 4 years from U.S. market
Transcatheter mitral valve replacements are at least 4 years out from hitting the U.S. market, despite the $2 billion recently dropped on companies developing the technology by some of the top names in medtech. Medtronic (NYSE:MDT), Abbott (NYSE:ABT), Edwards Lifesciences (NYSE:EW) and HeartWare International (NSDQ:HTWR) in recent months have spent a total of $2 billion to buy […]
Mitralign launches feasibility trial for Trialign tricuspid valve repair
Mitralign said today that it enrolled the 1st patient in the Scout feasibility trial of its Trialign tricuspid valve repair device under an investigational device exemption. The Tewksbury, Mass.-based company’s Trialign device is designed to use wire and catheters to implant polyester anchors within the annulus of the tricuspid valve, which separates the heart’s right atrium and right ventricle. The anchors […]
Biotronik’s Eluna 8 MRI-safe pacer hits the market in Japan
Biotronik yesterday said that its Eluna 8 MRI-safe pacemaker hit the market in Japan, for 1.5-tesla full-body scans and conditional 3T scans. “Heart disease is the 2nd-most prominent cause of mortality in Japan and we at Biotronik are committed to saving lives of those affected by it. By opening up full-body MRI scanning possibilities for device […]
St. Jude wins CE Mark for MR-safe Quadra Assura CRT-D
St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union for MRI-conditional labelling for its Quadra Assura cardiac resynchronization therapy defibrillator. The Quadra Assura CRT-D is compatible with MRI scanning systems up to 1.5 Tesla, St. Paul, Minn.-based St. Jude said. “The Quadra Assura CRT-D MRI allows patients to continue to […]
Biotronik launches trial of CLS AF algorithm
Biotronik said today it enrolled the 1st patient in its B3 trial examining the company’s Closed Loop Stimulation physiologic rate response sensor and algorithm. The study aims to whether pacemakers and implantable cardioverter-defibrillators equipped with the CLS sensor and algorithm are able to reduce the rate of stroke and improve outcomes in patients with atrial […]
QT Vascular wins stay in $20m loss to AngioScore
QT Vascular and a pair of related companies last week won a stay in their $20 million loss to AngioScore so their appeal can proceed. In July, a federal judge ruled that founder Eitan Konstantino violated his duties to AngioScore when he started QT Vascular, TriReme Medical and Quattro Vascular. AngioScore, which Spectranetics (NSDQ:SPNC) acquired last year for $230 million, accused Konstantino of breaching his fiduciary duties […]
FDA: Class II recall for Medtronic’s InSync III pacemakers
A battery longevity issue prompted Medtronic this month warn doctors about some 96,787 of its InSync III pacemakers, an action the FDA labeled a Class II recall, although Medtronic said only about 22,000 of the devices are still active. The Fridley, Minn.-based medical device titan sent a letter to physicians dated November 2015, warning that a high […]
UPDATE: FDA deems Boston Scientific’s atherectomy component recall Class I
The FDA last week slapped Class I status on Boston Scientific‘s (NYSE:BSX) recall of nearly 1,000 components used with its Rotablator atherectomy device. Boston Scientific warned doctors of the potential problem in October, after receiving 3 reports that the catheter’s guidewire fractured during procedures to remove plaque from the coronary arteries. In 1 case, the patient died 4 days after the […]
Report: Medicare proposal would broaden coverage for Boston Scientific’s Watchman
The Centers for Medicare & Medicaid Services are reportedly considering broadening the coverage for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device, according to an unidentified official with the federal health insurer. Leerink Partners analyst Danielle Antalffy, citing a Bloomberg report, wrote today that the CMS official “clarified that CMS is proposing to pay for Watchman for a subset […]
Mirowsky fights $6m legal tab in Medtronic spat
Mirowski Family Ventures, on the hook for a $6 million tab for Medtronic‘s (NYSE:MDT) legal costs, told a federal appeals court last week that a lower court misconstrued a 24-year-old deal with Eli Lilly (NYSE:LLY). The long-running case involves patents licensed to Boston Scientific (NYSE:BSX). MFV represents the estate of Dr. Michel Mirowski, who helped invent the implantable defibrillator. The group, which controls several patents related […]