FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs / Submissions and Approvals

Bard Submits PMA for Drug-Eluting Balloon

Dec. 3, 2013

CR Bard has filed for premarket approval of its Lutonix drug-coated dilatation catheter.

Bard’s PMA is based on three trials, including an ongoing investigational device exemption trial evaluating the balloon’s safety and efficacy compared to standard angioplasty balloons.

Bard’s balloon differs from other angioplasty balloons in its paclitaxel coating, the company says. The strength of the coating allows surgeons to deliver the balloon to the intended vessel, while the absorption of the drug prevents the artery from collapsing after surgeons have inflated the balloon to restore blood flow, Bard says. The balloon device is then deflated and removed.

Lutonix would be the first balloon of its kind approved in the U.S. It is currently available in Europe and several other countries. — Lena Freund

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.