September 15, 2010
Angioslide Commercializes First Balloon Angioplasty Device in the US
Angiodslie announced today that the company has commercialized the Proteus device for Embolic Capture Angioplasty (ECA) in the United States. The device combines an angioplasty balloon and embolic capture feature into one device, thus providing physicians with a simple and cost-effective method of capturing of embolic particles during angioplasty procedures
Proteus is a one of its kind device to combine balloon angioplasty and embolic capture to receive FDA clearance, which was received in April 2010. The Proteus device is presently indicated for use in the lower limbs during Percutaneous Transluminal Angioplasty (PTA) procedures.
Proteus joins the new class of medical devices aimed at treating peripheral arterial disease (PAD), one of the fastest-growing segments in the worldwide interventional marketplace. An estimated 10 million patients suffer from PAD in the U.S. alone, of whom approximately 1,000,000 undergo a revascularization or amputation procedure each year. PTA procedures are a common treatment for peripheral artery disease for opening up the artery to improve blood flow. However, one potential complication of a PTA procedure is debris from the artery wall being disturbed during the procedure and floating through the blood stream. In the worst case this floating debris can totally occlude the artery and cause complete lack of circulation to the lower limb.
The Proteus device combines a standard angioplasty balloon with a feature that can capture the debris that maybe liberated during the PTA procedure. Proteus has the same characteristics as a standard angioplasty balloon but the embolic capture feature allows debris to be trapped within the balloon and removed as the physician removes the angioplasty balloon at the end of the PTA procedure.
"We believe that Proteus and Embolic Capture Angioplasty (ECA) represents a major advancement in the approach to angioplasty procedures. We are actively commercializing the Proteus in the U.S. via our direct sales force. In a relatively short time we are already active in over 15 hospitals in US and are very pleased with the acceptance of the device," said Doron Besser, President and CEO of Angioslide
Besser added, "This entry of Proteus into the U.S. market for is expected to be only the first in a series of applications of the technology such as the coronary, renal and carotid vascular beds.
"I am very pleased with the use of the Proteus device in my patients. It is simple to use and cost effective and I can now be assured that my patients will have a significant reduction in risk from the PTA procedure," said Dr. Subhash Banerjee, Chief, Division of Cardiology, from VA North Texas Health Care System, Dallas, TX.
"Being part of the company's Scientific Advisory Board from its early days, I am very excited that Proteus has received FDA clearance for use in the lower limbs. Proteus and Embolic Capture Angioplasty will reduce the risk of complications for our patients and in the future could become the gold standard for angioplasty procedures," said Dr. John Laird, Medical Director, UC Davis Vascular Center, Sacramento, CA.
Investors in Angioslide include Ofer Hi-Tech, Viola Group, Itochu Corporation and Agate Medical Investments.
United States operations are led by Tom Doorley, Senior VP of Sales, and John Schorgl, both former executives with Schneider/Pfizer.