Integra® Flowable Wound Matrix Gets CE Nod For Diabetic Foot And Leg Ulcers

In short

U.S. medtech company Integra has received European CE Mark Certification for its Integra® Flowable Wound Matrix, which it describes as an advanced device for filling deep soft tissue or tunneling wounds, including diabetic foot and leg ulcers.

Background

The incidence of diabetes continues to accelerate and many of the amputations resulting from diabetic foot ulcers, could be prevented with proper intervention, which is where Integra hopes its wound Flowable Wound Matrix steps in. As the name suggests this is the flowable version of Integra’s wound matrix and uses the company’s proven collagen technology, whose effectiveness has been widely demonstrated over the past 20 years in a variety of indications, including life-threatening burns and scar revisions.

The product’s release in Europe is backed by five years of use in the United States and Latin America, where it is already used to meet the specific clinical requirements for managing wounds, including partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunnelled/undermined wounds, surgical wounds, trauma wounds and draining wounds.

As if a CE mark wasn’t enough, the Société Française de Chirurgie Plastique Reconstructrice et Esthétique (SOF.CPRE) (French Society of Reconstructive and Esthetic Plastic Surgery), one of Europe’s pre-eminent medical associations, has also awarded Integra’s Flowable Wound Matrix 1st place in its innovation contest. Each year, over 1,000 surgeons attend the annual meeting and are asked to vote on the most innovative new product, based on its performance. This year, the majority of the voters selected Integra’s Flowable Wound Matrix.

Company comments

“We are extremely honored that Integra’s Flowable Wound Matrix has been recognized by surgeons as one of the most innovative new products available for the management of chronic wounds,” said Debbie Leonetti, Integra’s Corporate Vice President, President – International. “Tens of thousands of patients in Europe suffer from chronic foot and leg ulcers that progress to deep or tunneling wounds, and they face serious risk of amputation. Integra’s Flowable Wound Matrix now offers surgeons, and patients, a new option for managing these hard-to-access wounds.”

“The product’s reputation has spread well beyond American borders, and many European wound specialists are waiting for it,” said Marie-Ange Passemard, EMEA Marketing and Sales Director, Integra Skin and Wound. “Thanks to its release on the European market, we will be able to meet demand from centers specialized in treating chronic wounds, which are faced with a steep increase in the number of diabetes-related pathologies. This is good news for patients, who will have an alternative to the usual treatment for their wounds.”

Source: Integra Lifescience Holdings, Inc., Globe Newswire