Paris-based SafeHeal has begun a CE mark study for its Colovac device that is designed to be used as a bypass after a rectal resection and prevents the need for an ostomy.
The study has enrolled its first five patients of what is planned to be a 15-patient study approved by the French health authority. The first two procedures were performed at the Institute of Image-Guided Surgery in Strasbourg in collaboration with the CHRU Strasbourg.
The device was designed to avoid the need for diverting ostomy in patients undergoing colectomy. The Colovac is a flexible bypass sheath intended to reduce any contact of fecal content with the colorectal anastomotic site, following colorectal surgery that is either open or laparoscopic.
More than 400,000 rectal resections are performed globally each year, the company said.
“Colovac has the potential to significantly improve the outcomes and experience of our patients while avoiding diverting stoma for the majority of patients,” Jérémie Lefèvre, M.D., Ph.D., said in a statement. Lefèvre performed three other study surgeries on patients at the Hospital Saint-Antoine in Paris.
Anastomotic leakage, which occurs in about 20% of patients undergoing anterior resection, is considered to be the most serious colorectal surgical complication. It can result in severe peritonitis, septic shock and multiple organ dysfunction. Although ostomy is the current standard to help reduce the risk of anastomotic leakage, it can significantly reduce the quality of life for a patient and can result in other complications.