Edwards might be primarily known for its TAVR systems, but the company has been making some interesting forays into the artificial intelligence realm.
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.
The imaging process was developed by a team of researchers from Northwestern University and could help lead to the early diagnosis of disease.
The suspension follows the Irvine, CA-based company’s voluntary recall of the device earlier this month.
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 collaboration will use the Apple Watch to measure the outcomes of J&J’s heart health engagement program.
The acquisition comes hot on the heels of Boston Scientific making a significant acquisition into the mitral valve space.
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 San Francisco-based company and developer of the Zio Patch is set to present at the 37th Annual J.P. Morgan Healthcare Conference this week.
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.
FDA’s nod for the Sapien 3 Ultra valve comes at a time when the TAVR market is heating up with competition.
The Marlborough, MA-based company strengthens its structural heart portfolio and gains a deeper foothold in a market where Medtronic, Abbott Laboratories, and Edwards Lifesciences have already made significant acquisitions.