CeloNova BioSciences yesterday released data from the Shield trial of its Cobra PzF nanocoated coronary stent, announcing the trial met its primary and secondary endpoints. Results from the study were published in the Journal of the American College of Cardiology: Cardiovascular Interventions this month. The Cobra PzF coronary stent has a novel Polyzene-F nano-coating and thin-strut […]
Cardiac Implants
Heart failure devices: This amazing new robot could be the future
A new customizable robotic heart sleeve has demonstrated potential when it comes to aiding the beating of a failing heart, according to the Harvard University and Boston Children’s Hospital researchers who developed it. The researchers claim that the soft robot has advantages over the heart assist devices such as VADs that are out there because […]
St Jude releases FDA-cleared Merlin@home cybersecurity update
Updated with comment from Muddy Waters. Abbott (NYSE:ABT) subsidiary St. Jude Medical said today it launched a cybersecurity update for its Merlin@home remote monitoring system designed for use with implantable pacemakers and defibrillator devices. The Little Canada, Minn.-based company said the move was made to “complement the company’s existing measures and further reduce the extremely low […]
Researchers uncover hackable ‘fatal flaws’ in defibrillators
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, […]
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 […]