Jun 24 2010
IDEV Technologies, Incorporated (IDEV), an emerging leader in the development and marketing of minimally invasive medical technologies, today announced that it has entered into an exclusive distribution agreement covering the U.S. and Germany for TriReme Medical, Inc.'s (TriReme) GliderXtreme™ PTA balloon catheter, an advanced product with specific features for the expanding Peripheral Arterial Disease (PAD) market. The PAD market represents more than a $2.5 billion device revenue opportunity in the U.S., growing at nearly 10 percent annually with significant opportunities for next generation stents and balloon catheters. IDEV expects to launch the GliderXtreme in the third quarter of 2010.
TriReme recently received clearance from the U.S. Food and Drug Administration (FDA) for the GliderXtreme catheter, a highly differentiated advanced balloon catheter system with an expanded matrix of sizes including longer balloon lengths, an atraumatic tapered tip and shaft construction reinforced for torque transmission and exceptional pushability. GliderXtreme is designed to cross difficult and highly diseased lesions to restore blood flow in complex anatomy.
"IDEV is building a strong global foundation, which makes it an ideal partner for us," Dr. Eitan Konstantino, President and CEO of TriReme said. "IDEV's proven commercial capabilities are undeniable. In addition, both companies are engaged in the development of future tools for the PAD market, IDEV with its durable, flexible, and easy-to-use SUPERA® stent and TriReme with the GliderXtreme, a next generation balloon catheter technology designed to cross a broad range of lesions. We look forward to working with IDEV to drive market adoption."
IDEV's self-expanding SUPERA interwoven nitinol stent is a novel stent platform designed for the treatment of biliary and peripheral artery diseases. The SUPERA stent has received CE Mark approval in Europe for biliary and peripheral vascular indications and is currently the focus of a prospective, FDA-IDE approved, single-arm clinical trial in 258 patients at up to 40 sites in the U.S. The company is also focused on developing and adding highly differentiated products to its portfolio.
Christopher M. Owens, President and CEO of IDEV, commented that, "IDEV and TriReme are both creating advanced, innovative products to fill significant unmet needs in rapidly expanding medical device markets. We are very impressed with TriReme's catheter products and development capabilities. Given the promising results and growth opportunities we are experiencing with our SUPERA stent, adding a complementary and technologically advanced product offering makes sense both strategically and clinically. We look forward to working closely with TriReme."
Source:
IDEV Technologies, Incorporated