Biotronik touts IDE approval, 1st implant for Pulsar-18 stent in Bioflex-I trial

Biotronik won FDA investigational device exemption and announced the 1st U.S. implant of its latest-generation Pulsar-18 self-expanding stent.

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.