Cardiovascular medical device maker Biotronik touted FDA investigational device exemption for and 1st U.S. implantation of its Pulsar-18 self-expanding stent, the latest in the company’s line of peripheral artery stents.
The FDA approval granted the Lake Oswego, Ore.-based company approval to add U.S. patients to its prospective, non-randomized study of the Pulsar-18 stent in the BioFlex-1 trial, which also includes centers in Europe and Canada, according to a press release.
The Pulsar-18 stent is designed for use in the superficial femoral artery, and features extended lengths for treated lesions of various sizes. The self-expanding stent is fully compatible with the 4F sheath system, which offers a range of stent diameters from 4-7 mm and lengths from 20-200mm, Biotronik noted.
“Performing an entire procedure through a 4F sheath can reduce the risk of patient bleeding and allow them to ambulate more quickly," Dr. Carlos Mena of Yale University Medical Center, who performed the initial Pulsar-18 implantation, said in prepared remarks. "I’m excited to be able to provide these benefits to my patients using an entirely 4F system of tools.”