Jul 2 2013
Devon Medical, a global medical device manufacturer, designer, and distributor, announced today that it has received medical device registration and approval from the Brazilian National Health Surveillance Agency (ANVISA - Agência Nacional de Vigilância Sanitária) for its extriCARE® 2400 Negative Pressure Wound Therapy (NPWT) pump.
“The ANVISA certification is an important milestone for Devon Medical and our regulatory strategy”
ANVISA is Brazil's regulatory authority for medical devices, drugs, and other products seeking to enter the country. The approval allows Devon Medical to sell its extriCARE® NPWT system, which comprises the extriCARE® 2400 pump and the company's NPWT dressings, in the Brazilian market. Devon Medical received ANVISA approval for its NPWT dressings in April.
"The ANVISA certification is an important milestone for Devon Medical and our regulatory strategy," says Dr. John A. Bennett, founder of Devon Medical. "Brazil is a dynamic and rapidly-growing country thirsting for new ideas in medicine, specifically in medical device technology and wound care. We have made connections with various physicians and distributors in the country who believe our approach to mobile wound care can be a competitive alternative to current practices. We look forward to the expanded use of our extriCARE® NPWT system in Brazil and to working with its clinicians to advance wound healing treatment and help patients."
The extriCARE® 2400 pump weighs only 8.6 ounces and works with Devon Medical's anatomically fitted NPWT dressings. A dressing is applied to a wound to create a tight seal, and the pump's pressure creates a negative pressure or vacuum environment that draws blood to the wound bed. The process also removes exudates into a disposable canister located on the back of the pump.
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