In a surprise move, the FDA rejected andexanet alfa (AndexXa), the antidote to anticoagulants like apixaban (Eliquis) and rivaroxaban (Xarelto). The agency had previously designated the drug as a Breakthrough Therapy — now, there is still no FDA-approved drug to reverse major bleeding with Factor Xa inhibitors.
Enveo R, the delivery catheter for Medtronic’s Evolut R transcatheter aortic valve replacement (TAVR) device, was linked to vascular trauma in 39 patients (19 of whom died). No device defects appear to be at fault: instead, the company is revamping its instructions for use, recommending that operators not force the catheter when encountering resistance.
The discovery of tiny glass shards contaminating the Roadrunner Uniglide Hydrophilic Wire Guide led to its recall. There had not been any reports of vessel damage or bleeding when manufacturer Cook Medical urged customers to return the product.
Analysts project a modest impact to the bottom line of most hospitals after participating in the new Medicare cardiac bundled payment models, which are set to be phased in on July 1, 2017. Based on current spending patterns, 85% of centers would gain or lose less than $500,000 a year.
Injecting mice with AGGF1, a gene that induces blood vessel formation, was linked to a reduction in infarct size and cardiac cell death rates after a myocardial infarction. Angiogenic factor therapy may be an alternative to percutaneous coronary intervention or coronary artery bypass grafts for patients with very small blockages, a study author told MedicalResearch.com.
TAVR with the 20 mm SAPIEN XT device was safe, a study found. Transaortic gradients fell in both patients with native aortic stenosis and those undergoing valve-in-valve procedures, with low 30-day rates of aortic regurgitation to boot (7% and 0%, respectively).
Adding the Angio-Seal vascular closure device to a femoral strategy yielded similar odds of access site complications at 30 days when compared to the radial approach, a study found.