European regulators revoked approval of omega-3 fatty acids for cardiovascular prevention after heart attack (affecting products by Pfizer, Mylan, Teva, and BASF/Pronova BioPharma) after finding them ineffective. However, icosapent ethyl (Vascepa) was not included.
Amazon’s Alexa can manage blood pressure monitoring with Omron devices. (CNBC)
Low-sodium diets have a “shockingly small amount of evidence” in heart failure, although a couple of randomized trials are on the way, the New York Times notes.
The FDA “lambasted” Zhejiang Huahai, the Chinese company behind contamination of valsartan and related drugs with a probable carcinogen, in a savage warning letter for failing to detect the problem when a customer complained several years ago. (FiercePharma)
Heart attacks are up 40% on Christmas Eve, a study in the BMJ‘s annual Christmas edition showed. (USA Today)
A donor heart being sent from California to Seattle on a Southwest Airlines plane was left on board, prompting a mid-flight turnaround. (Fox News)
The EU review is delayed pending more information for andexanet alfa (Andexxa, Ondexxya in Europe) in reversal of Factor Xa inhibitor anticoagulants in cases of uncontrolled or life-threatening bleeding. (MarketWatch) The drug is approved in the U.S.
The first transcatheter aortic valve replacement (TAVR) device designed and manufactured in India, dubbed MyVal, was approved for use there. (NDTV)
Femoropopliteal stents and balloons with paclitaxel were associated with higher 1-year mortality risk than angioplasty or stents without it, a meta-analysis reported in the Journal of the American Heart Association.
A federal jury awarded damages in finding that the Sapien 3 TAVR device infringes on a Boston Scientific patent, although defendant Edwards plans to appeal. The jury turned down claims that Boston Scientific’s Lotus TAVR infringes on Edwards’ patents. (CRTonline.org)
The Vanguard IEP peripheral balloon with an embolic protection function got FDA clearance for treatment of peripheral artery disease. (Mass Device)
Janssen announced it has applied for expanded approval of rivaroxaban (Xarelto) to cover prevention of venous thromboembolism in acute medically ill patients.
Living near an oil field or natural gas extraction site is associated with poorer arterial health, a study from Colorado suggested. (Cardiovascular Business)