Exploitable cybersecurity flaws that could be fatal were found in 10 different implantable medical devices, according to a new report from a European research team. Researchers at Belgium’s KU Leuven University examined 10 device, specifically implantable cardioverter defibrillators. The team used only commercial, off the shelf items and had no prior knowledge of the devices, […]
Cardiac Implants
France’s drugs agency freezes Carmat implants after 5th death
France’s national drugs agency said today it is ordering artificial heart maker Carmat (FRA:CXT) to freeze implantation of its devices after the death of a 5th patient last month. The company distanced itself from the death, with chief exec Stephanie Piat stating that the artificial heart was not involved and that the last 3 implantations of the […]
Medtronic wins EU nod for less-invasive HVAD implant procedure
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for a less-invasive implant procedure for the HVAD system left ventricular assist device it acquired along with HeartWare in August. The new implantation procedure uses a smaller incision than the previously cleared procedure, Fridley, Minn.-based Medtronic said, potentially lessening bleeding and related […]
Corvia Medical touts 1-year data for InterAtrial shunt
Corvia Medical today released 1-year results from the Reduce LAP-HF clinical trial of its InterAtrial shunt device, touting a good safety profile and sustained device performance. Results from the 64-patient study was presented at the American Heart Association’s 2016 Scientific Sessions. The Tewksbury, Mass.-based company’s IASD is designed to lower blood pressure in the left atrium […]
Medicare issues leadless pacer coverage proposal
The Centers for Medicare and Medicaid Services said this week it is changing its coverage to now cover leadless pacemakers, but only for FDA approved studies. The change comes with a newly released draft of CMS’ national coverage determination for the devices, which outlines 3 protocols the studies must address to receive coverage. Currently, Medtronic‘s […]
Biotronik launches high energy Inventra HF-T ICD
Biotronik said today it launched the “ultra-high” energy Inventra HF-T, touting it as the 1st and only implantable cardioverter defibrillator available to deliver 42 joules in the 1st shock. The new addition to Biotronik’s line includes the company’s DX system, which offers dual-chamber diagnostics with a single specialized defibrillator lead. “For an increasing number of patients […]
St. Jude wins CE Mark for MRI safe labeling for Quadra CRT-P
St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union to add magnetic resonance imaging conditional labeling to its Quadra Allure MP cardiac resynchonization therapy pacemaker. The company’s Quadra Allure MP CRT-P is now cleared as operable with diagnostic MRI scans of up to 1.5 Tesla, the St. Paul, Minn.-based company said. […]
Abbott wins Japanese approval for Absorb
Abbott (NYSE:ABT) said today it won approval from the Japanese Ministry of Health, Labor and Welfare for its Absorb bioresorbable heart stent, touting it as the 1st fully dissolving heart stent approved in the country. The stent is now cleared for use in patients with coronary artery disease, the Chicago-based company said, with approval coming […]
LVAD dev CorWave raises $17.1m in Series B
Circulatory support device developer CorWave said today it raised $17.1 million in a Series B round of financing to support its novel left ventricular assist device. The round was led by new investor Novo Seeds, joined by existing shareholders Sofinnova Partners, Bpifrance and Seventure and joined by new investor Ysios Capital. CorWave said it has […]
TCT 2016: Structural heart, drug-coated balloons take their turn on Day 3
The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning Oct. 29. We’ll update this post throughout the day as new results come in, so be sure to check back for the latest news out of TCT 2016. After stents took center stage Day 1, with a raft of […]
Report: St. Jude sold off older CRM devices after learning of battery issue
Updated: Corrected date of recall from 2015 to October 2016. St. Jude Medical (NYSE:STJ) continued to distribute outdated pacemaker devices that were indicated in a recall due to battery faults, even after correcting the flaw and producing new units, according to a StarTribune report. The devices were recalled last month over issues with batteries failing with […]