The FDA's Circulatory System Devices panel voted 9-2 Wednesday after the market close to recommend approval of the HeartWare ventricular assist system (VAS) as a bridge-to-transplantation (BTT) for patients with end-stage heart failure. Despite some concerns about safety, the panel decided the benefits outweigh the risks for the new device from HeartWare (Framingham, Massachusetts), which is implanted next to the heart.
Abbott (Abbott Park, Illinois) reported FDA clearance to use its iFS advanced femtosecond laser to create bow-shaped or curved arcuate incisions in corneal surgery, including cataract surgery.
St. Jude Medical (St. Paul, Minnesota) reported the first implant in its Accent MRI pacemaker and Tendril MRI lead IDE study. The study is designed to determine if patients with these devices can safely undergo full-body, high resolution MRI scans to better accommodate their medical needs. The Accent MRI pacemaker system from St. Jude offers and advanced pacing platform that provides wireless telemetry and algorithms to help address individual patient conditions, the company said.
Patients suffering from peripheral artery disease (PAD) in the superficial femoral artery and/or proximal popliteal artery traditionally have not had very good treatment options.
