University of Texas Engineers have developed a noninvasive way to simulate repairs to the heart's mitral valve allowing surgeons to provide patient-specific treatments.
Prompted by a recent publication in the Journal of the American Heart Association that suggests a possible increased risk of death at two years and beyond in patients treated with vascular balloons coated with paclitaxel or stents that release paclitaxel, FDA said it is evaluating data and working directly with manufacturers to better understand this issue.
The Irvine, CA-based company is slated to pay out $180 million to Boston Scientific in a move that would end both firms’ outstanding TAVR lawsuits and injunctions.
The Irvine, CA-based company said it was limiting the device to only be available for use under clinical protocol with pre-screened patients that adhere to the current indications.
In 2014, renal denervation procedures to treat resistant hypertension took a crippling blow, when Medtronic failed to meet the primary endpoints in a trial, but recent activity from the Dublin-based firm and others indicates that the space is hot once again.
A recently-published meta-analysis showed higher mortality rates with Paclitaxel drug-coated balloons and drug-eluting stents, and at least two drug-eluting device trials have been paused.