SafeHeal's Colovac device receives EU marketing approval

PARIS/TAMPA - SafeHeal has received European Union marketing approval for its Colovac device under the new Medical Device Regulation (MDR), the company announced Thursday.

The Colovac technology is designed as an alternative to temporary diverting ostomy for patients undergoing colorectal cancer resection. The approval allows for commercial distribution across European Union markets.

The endoluminal bypass system aims to eliminate the need for a temporary stoma in patients recovering from colorectal surgery. Traditional diverting ostomy procedures require patients to use an external bag to collect waste while the surgical site heals, followed by a second surgery to reverse the ostomy.

"This is a pivotal achievement for our company," said Chris Richardson, President and Chief Executive Officer of SafeHeal, in a press release statement.

The Colovac device is placed endoluminally and remains in place for approximately 10 days until the body’s natural healing process is complete. It is then removed during an endoscopic procedure without requiring additional surgery.

According to the company, this approach could help patients avoid complications associated with ostomy procedures, including the possibility of permanent stoma and the physical and emotional burdens of stoma management.

The device has been studied in clinical trials across the United States, Europe, and Asia. In the U.S., the Food and Drug Administration has granted the product Breakthrough Device Designation, which expedites review for technologies that may improve treatment of life-threatening or irreversibly debilitating conditions.

In the United States, Colovac remains limited to investigational use and is not currently available for sale.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.