IDEV launches SUPERA VERITAS Peripheral Vascular System in Europe

May 18 2010

IDEV Technologies, Incorporated, (IDEV) an emerging leader in the development and marketing of minimally invasive medical technologies, today announced the European launch of the SUPERA VERITAS™ Peripheral Vascular System, a novel and innovative stent delivery system designed to be reliable, easy to use and precise. The SUPERA VERITAS system was formally launched in the first quarter of 2010 at the Leipzig Interventional Course (LINC) 2010 conference in Leipzig, Germany.  The LINC conference is dedicated to advancing clinical solutions for patients with complex vascular disease.

The SUPERA VERITAS system was developed by IDEV to deliver the Company's innovative, self-expanding SUPERA® interwoven nitinol stent, a novel stent platform designed for the treatment of biliary and peripheral artery disease (PAD). Driven by an aging population, sedentary lifestyles, an increasing prevalence of obesity and diabetes, and increased disease awareness and screening, it is estimated that the market for devices treating peripheral vascular disease is accelerating at a double digit annual growth rate. Millions of patients worldwide are suffering from peripheral vascular disease with very few treatment options available.

Professor Dierk Scheinert, M.D., Chairman of the Center for Vascular Medicine at the Park Hospital Leipzig, Germany, said, "We have been utilizing the SUPERA stent clinically for more than two years and we are very impressed with the performance of the stent and positive clinical outcomes. It represents a significant advancement in stent technology and its unique characteristics allow physicians to treat areas where standard 'slotted tube' nitinol stents have always encountered difficulty.

"With the new SUPERA VERITAS delivery system, we now have a more effective tool for the smooth and controlled deployment of the SUPERA stent.  It significantly reduces the number of steps needed to prep and deliver the stent, all of which greatly increase its ease of use and accuracy," Dr. Scheinert added.

IDEV Chief Executive Officer Christopher M. Owens said: "The early clinical results using our novel stent delivery system have been impressive and have demonstrated IDEV's capacity for innovation.  Physician feedback on the new SUPERA VERITAS delivery system indicates that we have provided the operator with a product that has improved durability, reliability, accuracy and ease of use.

"These results have triggered significant interest in our stent.  We have been very pleased with the early acceptance of our new SUPERA VERITAS delivery system since introducing it to a European audience at LINC 2010," Owens added.  "We recorded a year-over-year revenue growth rate of nearly 70 percent in the first quarter of this year, and we anticipate an increasing rate of adoption and sizeable increases in market share as the launch of our new delivery system gains even greater traction in the market."    

The Company expects to introduce two additional products in its family of SUPERA stents by the end of this year.

Professor Thomas Zeller, M.D., of the Department of Vascular Medicine, Heart Center in Bad Krozingen, Germany, noted that the SUPERA VERITAS delivery system was designed to complement the flexible SUPERA stent in the treatment of obstructive arterial disease in the superficial femoral artery of the lower extremity.

"The introduction of the SUPERA VERITAS system substantially improves the delivery of the innovative and unique SUPERA stent," Dr. Zeller said.  "SUPERA may be the most durable and flexible stent currently on the market for use in treating PAD, and I believe this stent system will prove to be an important advancement in the treatment of the disease."

The SUPERA Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary system has received 510(k) clearance for palliative treatment for biliary strictures produced by malignant neoplasms.   The SUPERA Interwoven Self-Expanding Nitinol Stent System has received CE Mark approval in Europe for biliary and peripheral vascular indications. The SUPERA stent is currently the focus of a prospective, FDA-approved, single-arm clinical trial of 258 patients at up to 40 sites in the U.S.