Abbott (NYSE:ABT) won expanded pre-market approval from the FDA for its Absolute Pro self-expanding stent system, according to an agency release.
The next-generation device, delivered via catheter, is now additionally indicated for use in narrowed iliac arteries.
The device has been commercially available in the U.S. as a biliary stent since 2008 and is also sold in over 80 countries outside the U.S., according to FDA documents. The device has never been pulled from any market for any reason.
The company has yet to issue a release on the PMA win, but did mention in its Q4 earnings report that it planned to launch the Absolute Pro device this year.
The system is comprised of a self-expanding nickel titanium stent with 12 markers located at the ends and a delivery catheter with a retractable sheath.
Abbott Labs. did not return requests for comment.