Global medical devices firm Integra LifeSciences has obtained clearance from the European Union for its device aimed at treating diabetic foot and leg ulcers.
The EU accorded CE-mark approval to the new device, Integra Flowable Wound Matrix 2, which is already in use in the US and Latin America, allowing it to be released into the European market.
Integra Skin and Wound EMEA marketing and sales director Marie-Ange Passemard said European patients will get an alternative option from the usual treatment of wounds.
“Thanks to its release on the European market, we will be able to meet demand from centers specialised in treating chronic wounds, which are faced with a steep increase in the number of diabetes-related pathologies,” Passemard said.
The wound management device has been developed using the company’s collagen technology to fill deep soft tissue and tunnel wounds.
Being a flowable version of Integra’s wound matrix, the device is claimed to manage partial and full-thickness wounds, pressure and venous ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wounds, trauma wounds and draining wounds resulting out of diabetes.
Integra’s corporate vice president and international president Debbie Leonetti said several patients in Europe are suffering from chronic foot and leg ulcers, which could develop into tunneling wounds posing a risk of amputation.
“Integra’s Flowable Wound Matrix now offers surgeons, and patients, a new option for managing these hard-to-access wounds,” Leonetti said.
According to Integra LifeSciences, nearly 55 million people in European Union are affected by diabetes, out of which at least three million are likely to develop a foot ulcer.