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Devon Medical Products Receives FDA 510(k) Clearance for ArterioFlow(TM) Pump that Treats Diabetic Foot, Peripheral Arterial Disorders


4/13/2011 6:56:28 AM

KING OF PRUSSIA, Pa.--(BUSINESS WIRE)-- Devon Medical Products, a manufacturer and distributor of creative, safe, and cost-effective medical devices, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its ArterioFlow™ 7500 arterial pump that treats diabetic foot ulcers, peripheral arterial disease, and other chronic disorders of the lower extremities caused by reduced blood supply or ischemia. Devon Medical Products will feature the ArterioFlow 7500 and its line of CircuFlow™ compression pumps that treat lymphedema at the Medtrade Spring Conference at the Sands Expo and Convention Center in Las Vegas on April 13-14.

According to the 2011 National Diabetes Fact Sheet released by the American Diabetes Association (ADA) earlier this year, approximately 25.8 million people – 8.3% of the U.S. population – have diabetes. Various studies show that about 15% of diabetics develop diabetic foot ulcers, or open sores or wounds that develop as a result of poor circulation, trauma, and vascular complications. Six percent of people who develop foot ulcers are hospitalized annually due to infection, and 14-24 percent of people with diabetes who develop a foot ulcer have an amputation.

“Diabetic foot ulcers have proven to be the most common lower extremity injuries leading to amputation, and the compression therapy provided by the ArterioFlow increases blood flow to promote faster healing and prevent infection and amputation,” says Dr. John A. Bennett, CEO of Devon Medical Products. “While prevention of ulcers is ideal, immediate treatment of ulcers that do form is vital. Our goal with the ArterioFlow and all of our compression devices is to make therapy easy and convenient so that patients will comply more and in turn avoid terrible health consequences.”

The ArterioFlow applies compression to the foot and calf sequentially through compression sleeves to empty the veins in the lower extremities. In return, the arterial blood is more easily and readily delivered to the feet and blood-deprived tissues. The device can also be used to treat peripheral arterial disease, intermittent claudication, and other chronic disorders of the lower extremities caused by reduced blood supply or ischemia.

Devon Medical Products’ engineers and product developers designed the ArterioFlow. The company works with various distributors across the United States and abroad.

Visit Devon Medical Products in booth #1958 at the Medtrade conference for more information.

About Devon Medical Products

Devon Medical Products (www.devonmedicalproducts.com) is an international medical device manufacturer and distributor that provides the medical community with creative, safe, and cost-effective medical products. The company has cultivated an exclusive line of innovative medical devices designed to advance healthcare treatments and maximize safety for healthcare workers and patients worldwide. The company is headquartered in King of Prussia, Pennsylvania, and has international offices staffed with bilingual engineers, product developers, and FDA-regulatory experts.

Contact:

Devon Medical Products Darren M. Behuniak Director, Marketing & Communications 610-755-4958 dbehuniak@devonhealth.com


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