Healthcare Industry News:  peripheral artery disease 

Devices Interventional FDA

 News Release - September 22, 2008

IDEV Technologies Inc. and YMED Inc. Announce 510(k) Clearance for Larger and Longer Sizes of The VascuTRAK2(TM) PTA Dilation Catheter for the Treatment of Peripheral Artery Disease

HOUSTON--(HSMN NewsFeed)--IDEV Technologies Inc., distributor of the VascuTRAK2™ PTA Dilation Catheter, announced today its corporate partner YMED Inc. has received 510(k) clearance from the U.S. Food and Drug Administration to produce larger and longer Focal Force Angioplasty balloons for the treatment of peripheral artery disease. The VascuTRAK2TM PTA Dilation Catheter now offers the broadest array of balloon sizes for the treatment of lesions above and below the knee, as well as the iliac arteries and obstructive lesions of AV dialysis fistulae and grafts.

The VascuTRAK2 PTA Dilatation CatheterTM is approved in diameters of 2.0 mm to 7.0 mm and in lengths of 20 mm to 300 mm. The single operator, rapid exchange catheter is compatible with 0.014” and 0.018” guidewires. VascuTRAK2TM delivers 50 to 400 times the focal force of balloon angioplasty alone longitudinally along two external wires. Across the spectrum of TASC lesions, VascuTRAK2™ optimizes lumen enlargement while reducing the incidence of barotraumas due to lower atmospheric pressures required to achieve effective clinical results below and above the knee.

Tom Tully, Chairman and CEO of IDEV Technologies Inc., stated, “The introduction of the 200mm-300mm balloon lengths and larger diameter balloons into the peripheral market will expand use of Focal Force Angioplasty as a first line pre-dilation tool for patients suffering with peripheral artery disease.”

Yoav Shaked, CEO of YMED, said, “The excellent deliverability and crossing profile of VascuTRAK2TM along with the broadest range of sizes truly optimizes peripheral angioplasty and warrants use of this product for most of the indications that we might see.”

About IDEV. IDEV Technologies Inc., located in Houston, Texas, is an innovator and developer of next generation medical devices for use in the interventional radiology, vascular surgery and cardiology device marketplace. Its current portfolio contains over thirty technologies exclusively licensed from the M.D. Anderson Cancer Center, representing over a USD 5.0 billion dollar market opportunity worldwide.

About YMED. YMED Inc. is a privately held corporation established in 2004. The company was founded and is managed by a highly experienced, multinational team of medical, engineering and business professionals from within the cardio and peripheral vascular industry. This team develops, manufactures and markets innovative products for vascular intervention providing less invasive therapies for a broad range of circulatory diseases.

Source: IDEV Technologies

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