The Dublin-based company received approval for an expanded chronic total occlusion indication for its Resolute DES platform.
The Lake Oswego, OR-based company has received a nod from FDA for the Orsiro stent which it said outperformed Abbott’s Xience stent in a clinical study.
The Salt Lake City-based company said its Tria device is one of the first biopolymer heart valve platforms.
Duke University Medical Center researchers looked at data from 9,000 patients who underwent Cardiac Magnetic Resonance.
The Fully Implanted Ventricular Assist Device was developed using technologies from Jarvik Heart and Leviticus Cardio.
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.