FDA News

Medical Ventures Receives FDA Clearance for PeriPatch Aegis

(March 26, 2007) - Medical Ventures has received 510(k) clearance from the U.S. Food and Drug Administration for its new PeriPatch Aegis, a product designed to reduce complications during surgery. This clearance enables the company to begin marketing the product for sale in the United States.

PeriPatch Aegis is a system used to reinforce surgical staple lines during procedures such as bariatric surgery to treat morbid obesity, and thoracic surgery to treat certain kinds of lung disease. When used in conjunction with standard surgical staplers, the device can help physicians to reduce leakage and bleeding around staple lines. It can be used in minimally invasive laparoscopic and endoscopic procedures as well as in traditional open surgeries. The Aegis product incorporates Medical Ventures' proprietary PeriPatchTM bovine (cow-based) tissue technology.

Bariatric surgery to treat obesity, commonly referred to as "stomach stapling", is one of the fastest-growing medical procedures in the U.S. According to a recent Frost & Sullivan report, it is expected that more than 200,000 bariatric surgeries will be performed this year, up from only about 13,000 in 1998. It is also estimated that bariatric surgery will exceed 30 per cent growth over the next few years.

"Leakage along staple lines in the stomach or lungs after surgery can cause very serious complications or death," said Alexei Marko, Medical Ventures' vice president and chief operating officer. "Surgeons are increasingly using staple line reinforcement tools to help minimize the occurrence of such leaks. We believe that Aegis is the ideal product to meet this need, and with 510(k) clearance in place, we will begin working with our U.S. distributors to get it into the hands of our customers."

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