Endocare submits second PMA module to FDA for Horizon Prostatic Stent
Endocare Inc has submitted its second Pre-Market Approval module to the U.S. Food and Drug Administration (FDA) for its Horizon Prostatic Stent, a unique device designed to relieve suffering from acute urinary tract blockage. With this filing, the Company remains on track to meet their goal of completing the PMA submission in the first half of 2002.
The Horizon stent, which is made of nitinol, has an innovative shape-memory feature that allows it to be introduced and removed from a man's body through a minimally invasive procedure -- without surgery.
Endocare chairman and CEO Paul Mikus said the stent product could become a key part of the complete urology franchise the Company is developing.
Endocare recently announced it was broadening its urology franchise and extending its national sales force with the acquisition of Timm Medical Technologies Inc, a privately held medical device manufacturer and distributor.