US
Through the story of one colorectal cancer patient, the news feature highlights the SAFE-3CV clinical study, which has the potential to improve recovery and quality of life after colorectal surgery.
NBC10 Philadelphia recently featured a powerful patient story about SAFE-3CV, a clinical study evaluating SafeHeal’s investigational Colovac® device for patients undergoing colorectal cancer surgery.
The segment includes a woman navigating colorectal cancer treatment and the possibility of needing a temporary ostomy after surgery. For many patients, ostomy care can bring physical complications, lifestyle compromises, emotional challenges, and an extended recovery period — all during an already difficult time.
At Main Line Health, John Marks, MD, is serving as an investigator for the SAFE-3CV Study. The study is evaluating the safety and effectiveness of Colovac, SafeHeal’s groundbreaking endoluminal bypass sheath intended as an alternative to a temporary diverting ostomy for patients undergoing colorectal resection.
Colovac is designed to reduce contact of fecal content at the anastomotic site following colorectal surgery. By helping protect the surgical connection while the body heals, Colovac is being studied for its potential to eliminate the need for a temporary stoma in many patients, improve recovery and quality of life, and reduce the physical and emotional burden associated with stoma management and care.
We appreciate NBC10 Philadelphia bringing attention to this important area of colorectal cancer care and to the patients and clinical teams advancing research that may help patients avoid temporary diverting ostomy, reduce the burden of stoma management and care, and support improved recovery and quality of life after colorectal surgery.
Watch the NBC10 Philadelphia feature:
ABOUT SAFEHEAL®
SafeHeal SAS, headquartered in Paris, France, and its wholly owned U.S. subsidiary, SafeHeal Inc., is a medical device company developing Colovac®, a device intended as an alternative to diverting ostomy in patients undergoing colorectal surgery. Colovac® is a flexible endoluminal bypass sheath designed to reduce the contact of fecal content at the anastomotic site following colorectal surgery. The device is placed endoluminally and remains in place for approximately 10 days, until the body’s natural healing and tissue repair processes are complete, after which it is removed during an endoscopic procedure without the need for a second surgical intervention.
Colovac® is designed to protect colorectal anastomoses. In the United States, it is an investigational device and is not available for sale. In the European Union, Colovac® has received marketing approval under the Medical Device Regulation (EU MDR 2017/745) via Annex IX, Chapter I.