The Centers for Medicare and Medicaid Services have proposed new policy that could expand the use of transcatheter aortic valve replacement procedures, touting that it may provide more flexibility for starting and maintaining TAVR programs. The original National Coverage Determination for TAVR procedures was cleared in 2012, when the technology and associated procedure was still […]
CHF Solutions touts reduced cost, hospital stays in Aquadex Flex Flow ultrafiltation study
CHF Solutions (NSDQ:CHFS) today released results from a study of its ultrafiltration, such as with its Aquadex Flex Flow system, as compared to diuretic therapy for treating heart failure patients, touting a reduction in hospital duration and readmissions. The Eden Prairie, Minn.-based company said that results from the study were published in the Journal of Medical […]
Silk Road Medical sets downsized range for IPO
Silk Road Medical yesterday set the range on its forthcoming initial public offering, which would fetch $75 million at the midpoint. The Sunnyvale, Calif.-based company’s Enroute transcarotid stent and neuroprotection system is designed to treat carotid artery blockages before they cause a stroke. When it registered the IPO earlier this month, Silk Road said it […]
FDA clears Genetesis’ CardioFlux biomagnetic cardiac imager
Genetesis said last Friday it won FDA 510(k) clearance for its CardioFlux biomagnetic cardiac imaging platform. The newly cleared platform combines the CardioFlux magnetocardiograph with an integrated Faraday Analytical Cloud, the Mason, Ohio-based company said. Genetesis said that the CardioFlux uses a next-gen version of magnetocardiography that eliminates the need for liquid helium cooling, which […]
CardioFocus wins CE Mark for HeartLight X3 endoscopic ablation system
CardioFocus said today that it won CE Mark approval in the European Union for its HeartLight X3 endoscopic ablation system. The Marlborough, Mass.-based company said that the HeartLight X3 is its third-generation endoscopic ablation system intended to perform pulmonary vein isolation procedures using laser energy to block the abnormal electrical pathways that cause atrial fibrillation. The […]
IceCure Medical touts interventional radiology cryoablation study data
IceCure Medical yesterday released data from an interventional radiology study of its liquid-nitrogen-based cryoablation technology. Results from the study were presented at the Annual European Association of Urology Congress in Barcelona, the Israel-based company said. IceCure Medical’s ProSense cryoablation system uses liquid nitrogen technology for the treatment of benign and cancerous tumors through freezing, the […]
FDA approves Otimizer Smart heart failure device from Impulse Dynamics
Updated to include commentary from Impulse Dynamics. The FDA today said it approved the Optimizer Smart heart failure device developed by Impulse Dynamics under its breakthrough device designation. The Stuttgart, Germany-based company’s device is designed to remodel the myocardium to increase the heart’s efficiency using “cardiac contractility modulation” – non-excitatory electrical pulses delivered to the […]
Abiomed’s stake in Shockwave is worth at least $58m
The $10 million Abiomed (NSDQ:ABMD) put into Shockwave Medical (NSDQ:SWAV) has paid off so far no matter how you slice it. Shockwave raised nearly $97 million in an initial public offering earlier this month, inking a private-placement deal with Abiomed on the side for $10.0 million worth of SWAV shares at the $17-per-share IPO price. […]
ACC 2019 Roundup – ReCor touts six-month Paradise renal denervation study results
ReCor Medical this week released “on-medication” results from the RADIANCE-HTN-SOLO clinical trial of its Paradise renal denervation system intended to treat uncontrolled hypertension, touting medication and blood pressure reductions at six months. Results from the trial was presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans and were simultaneously published […]
ACC 2019 Roundup: Abiomed Impella RP post-market study shows benefit in select patient group
Abiomed (NSDQ:ABMD) today released 18-month post-approval study data from patients treated with its Impella RP, touting a benefit to survival for specifically selected “Recover Right” protocol patients. Results from the study were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans, the Danvers, Mass.-based company said. The review follows a release […]
ACC 2019: Abbott touts reduced stroke, bleeding and pump-clotting in HeartMate 3 trial
Abbott (NYSE:ABT) yesterday presented data from a new trial of its HeartMate 3 left ventricular assist device, touting a reduced rate of strokes, pump-related blood clots and bleeding episodes at two years as compared with the previous generation HeartMate II. Data in the trial was presented at the American College of Cardiology’s 68th Annual Scientific Session […]
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