Biotronik targets FDA approval with stent trial
|Biotronik has implanted its first Pulsar-18 stent in an IDE study--courtesy of Biotronik|
Biotronik has kicked off a multi-center investigational device trial for its Pulsar-18, targeting U.S. approval for its self-expanding device.
The device is designed for the superficial femoral artery, expanding into the vessel to treat femoral disease. The study--enrolling patients in the U.S., Canada and Europe--will evaluate the safety and efficacy of the stents families in treating peripheral arterial disease, seeking 12-month primary patency and 30-day and 12-month freedom from major adverse events.
A previous European study found a 12-month primary patency of 81.4% and a 12-month freedom from target lesion revascularization of 89.3%, positive results Biotronik hopes to replicate as it seeks FDA approval for its vascular devices.
Biotronik touts Pulsar-18's compatibility with a 4-French (4F) sheath system, which investigator Carlos Mena of Yale University Medical Center said makes the device impressively versatile. "Performing an entire procedure through a 4F sheath can reduce the risk of patient bleeding and allow them to ambulate more quickly," Mena said in a statement.
The stent is the next generation of the market-leading Astron Pulsar, and Biotronik launched the device overseas in 2010.
- read Biotronik's release