Devon Medical, a global medical device manufacturer, has received medical device registration and approval from the Brazilian national health surveillance agency, called Agência Nacional de Vigilância Sanitária, for its extriCARE 2400 Negative Pressure Wound Therapy (NPWT) pump.
The approval permits the company to market its extriCARE NPWT system, which comprises the extriCARE 2400 pump and NPWT dressings.
Devon Medical has received ANVISA approval for its NPWT dressings in April 2013.
The extriCARE 2400 pump, which weighs only 8.6 ounces, works with Devon Medical’s anatomically-equipped NPWT dressings.
A tight seal is created when a dressing is applied to a wound, and the pump’s pressure creates a vacuum environment that draws blood to the wound bed. Moreover, this process removes exudates into a disposable canister, which is located on the back of the pump.
Devon Medical founder John Bennett said that the ANVISA approval is an important milestone for Devon Medical and its regulatory strategy.
"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," Bennett added.