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CardioBreak: Renal Denervation Again, NOAC Reversal Agents - MedPage Today |
While both Boston Scientific and Medtronic are getting back to work with renal denervation, Forbes notes that pivotal phase III trials with the new generation of devices probably won't start until 2016. Meanwhile, 2015 could be "the prime-time year for prehypertension," Journal of the American Heart Association editorialists declared in response to a large meta-analysis indicating significantly increased coronary heart disease risk at even 120 to 129/80 to 84 mmHg, particularly in the Western world. Two models of the HeartWare ventricular assist device controllers put out during clinical trials before FDA approval (1400 and 1401XX) are being urgently recalled due to susceptibility to electrostatic discharge that could halt the pump. The recall (an expansion from one started in 2013) is expected to affect about 120 patients in the U.S., Trends-in-Medicine reports. A novel clot aspiration system tested in stroke also appeared "safe, effective" in the peripheral arteries in PRISM trial results presented at the Society for Interventional Radiology meeting. The American College of Cardiology released abstracts Monday from its upcoming conference for all but the late-breaking items and those featured in the press program. While it's the first time the ACC has provided early access (conference organizers said they wanted attendees to be able to plan what to attend), other heavy hitters like the American Society of Clinical Oncology have done so for years, in part due to stock market concerns. One notable abstract released was that of the phase III Annexa-R trial. While actual results aren't in the abstract, drugmaker Janssen announced that it showed that novel andexanet alpha significantly reversed the anti-clotting effect of rivaroxaban (Xarelto) in healthy individuals. Andexanet alfa gained orphan drug status from the FDA, putting it in line to be the first universal antidote to the factor Xa inhibitor anticoagulants, drugmaker Portola Pharmaceuticals announced. Accelerated approval is also being sought for idarucizumab as a reversal agent for dabigatran (Pradaxa), Boehringer Ingelheim announced. Hello, snowbirds: Mount Sinai Hospital is following the Cleveland Clinic and Mayo Clinic in expanding into warmer climes. The New York City institution's cardiovascular service is partnering with Jupiter Medical Center in South Florida. But don't confuse it with the Mount Sinai Medical Center Heart Institute already in South Florida, which is affiliated with Columbia University. Giving a baby with congenital heart disease its own umbilical cord stem cells could be a feasible treatment in the future, early phase research in piglets suggested. An autonomic nerve stimulation device (the Vitaria system) was approved in Europe to treat moderate-to-severe heart failure with ejection fraction less than 40% in patients symptomatic despite stable, optimal medication, device maker Cyberonics announced. Limited availability of Sorin's tissue heart valves should be coming to an end. The company announced that maintenance of clean rooms at its Italian facility was completed ahead of schedule. CardioBreak is a guide to what's new and interesting on the Web for cardiologists and other healthcare professionals with an interest in cardiovascular disease, powered by theMedPage Today community. Got a tip? Send it to us: This e-mail address is being protected from spambots. You need JavaScript enabled to view it . |