Boston Scientific (NYSE:BSX) this week presented new data from the Respond extension study of its Lotus transcatheter aortic valve replacement with its Depth Guard technology, touting no deaths and low rates of paravalvular regurgitation. Data from the study was presented at the Cardiovascular Research Technologies CRT 2017 annual meeting in Washington D.C. The 50-patient Respond Extension […]
Cardiac Implants
US Dept of Homeland Security updates on St Jude’s Merlin@home vulnerabilities
The US Department of Homeland Security this week published an updated advisory covering vulnerabilities associated with Abbott (NYSE:ABT) subsidiary St. Jude Medical’s Merlin@home devices. The agency warned that a vulnerability within the Merlin@home system could allow a third party to remotely “access or influence communications” between Merlin.net and transmitter endpoints, which could drain the battery or send […]
VisCardia closes $13m Series B, picks up Inovise Medical assets & tech
Novel heart failure device developer VisCardia said yesterday it closed a $12.5 Series B financing round and picked up the Inovise Medical’s assets and technology rights. Technology and assets from Inovise will support the continued development of VisCardia’s proprietary implantable heart failure therapy device, the Portland, Ore.-based company said. VisCardia’s implantable heart failure system is […]
Edwards pauses CardiAQ Valve clinical trial enrollment
Edwards Lifesciences (NYSE:EW) said this week it paused enrollment in the clinical trial of its CardiAQ transcatheter mitral valve implant while it performs design validation testing on the device. The Irvine, Calif.-based company said during an earnings conference call that it “saw something it wanted to go back and take a look at” and that it […]
Biotronik receives FDA warning on Berlin plant; launches Ilivia CRT-Ds
UPDATED Feb. 1, 2017, with comment from Biotronik. The FDA this week released a warning letter it sent to Biotronik over issues it identified during an inspection of its facilities in Berlin, shortly after the company announced the launch of its Ilivia cardiac resynchronization therapy devices. In the letter, the federal watchdog referenced 6 specific violations […]
Abbott wins FDA nod for MRI-safe Assurity pacemaker
Abbott (NYSE:ABT) said today that the FDA approved magnetic resonance-conditional labeling for its Assurity MRI pacemaker and its Tendril MRI pacing lead. The federal watchdog’s approval makes its Assurity device the world’s smallest, longest-lasting wireless MRI-compatible pacemaker, the company reported. During an MRI scan, Abbott’s MRI Activator device triggers pre-programmed MRI settings for the Assurity pacemaker, eliminating the need […]
Medtronic wins CMS coverage for Micra leadless pacer
Medtronic (NYSE:MDT) said today the U.S. Centers for Medicare and Medicaid Services released a National Coverage Determination which will cover leadless cardiac pacemakers, including the company’s Micra TPS. With the designation, Medicare patients will have access to Fridley, Minn.-based Medtronic’s Micra through Medicare’s policy of Coverage with Evidence Development, the company said. The Micra transcatheter pacing system, which […]
CeloNova touts study on Cobra PzF “nanocoated” coronary stents
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 […]
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, […]