IDEV Technologies, Inc.("IDEV"), an emerging leader in the
development and marketing of minimally invasive stent technologies,
today announces receipt of 510(k) clearance for a new SUPERA(TM)
Biliary Stent Delivery Catheter. The improved SUPERA(TM) Transhepatic
Biliary System is indicated for the palliative treatment of biliary
strictures produced by malignant neoplasms. The new SUPERA(TM) Biliary
Stent Delivery Catheter is the first to offer a retrieval capability
of up to 95% for a partially deployed SUPERA Biliary Stent.
The SUPERA(TM) Biliary Stent Delivery Catheter also provides the
operator with enhanced control during a procedure. A unique
reciprocating ratchet mechanism allows the operator to precisely place
the stent in the biliary tract.
The new SUPERA(TM) Biliary Stent Delivery Catheter was developed
specifically to address the unique design of the SUPERA(TM)
Self-expanding Biliary Stent. The SUPERA(TM) Self-expanding Biliary
Stent offers more than 360% greater radial force than other
commercially available laser cut nitinol tube ("LCNT") self-expanding
biliary stents. The unprecedented increase in radial force is due to
the novel Wire Interwoven Nitinol ("W.I.N.") design of the stent.
Unlike traditional LCNT self-expanding biliary stents, the W.I.N.
design allows for enhanced product radial force and flexibility.
Thomas M. Tully, Chairman and CEO commented, "U.S. 510(k) approval
for the SUPERA(TM) Biliary Stent Delivery Catheter is the third and
final regulatory step toward the global commercialization of this
novel technology. The first and second steps came earlier when IDEV
Technologies Inc. received 510(k) approval for the stent and an
earlier generation SUPERA(TM) Biliary Stent Delivery Catheter system
along with CE Mark approval for the SUPERA(TM) Peripheral Vascular
System in Europe. IDEV will begin working toward a domestic launch of
the SUPERA(TM) Transhepatic Biliary System in select medical centers
in the U.S. The first biliary cases will be scheduled at MD Anderson
Medical Center by the end of this week."
About IDEV Technologies, Inc.
IDEV Technologies, Inc. is an innovator and developer of next
generation medical devices for use in the interventional radiology,
gastroenterology, vascular surgery and cardiology device marketplace.
IDEV is based in Houston, Texas and its current portfolio contains
over thirty technologies exclusively licensed from the M.D. Anderson
Cancer Center, representing over a $5.0 billion dollar market
opportunity worldwide.
