Main Line Health surgeons at Lankenau Medical Center have quietly notched a national first, performing the initial U.S. operation using Colovac, a temporary internal bypass that aims to help rectal cancer patients avoid a temporary colostomy. The procedure, led by colorectal surgeon Dr. John Marks, was carried out as part of a multi-site clinical trial and marks an early American step for a device that has already been studied overseas.
How the Colovac Works
Colovac is a soft, flexible tube that sits inside the rectum and creates a seal so fecal matter cannot reach the fresh surgical repair. Instead, waste is channeled through the device and still exits through the anus rather than through a stoma in the abdomen. The implant is designed to stay in place for about 10 days before removal in a brief procedure that functions much like a colonoscopy. By contrast, a temporary diverting ostomy often remains for months and typically requires an additional surgery to reverse, according to Main Line Health.
The Trial And Regulatory Backdrop
Colovac is being tested in a pivotal IDE study known as SAFE-3CV, which plans to enroll about 252 patients at sites in the United States and Europe and is intended as the final step before the device maker seeks FDA clearance. SafeHeal, the company behind Colovac, announced the U.S. launch of the trial and first patient enrollments in January and reports that the device already carries EU marketing approval along with Breakthrough Device designation from the FDA, according to a company release reported by PR Newswire.
Local Surgeons Hope To Spare Patients From Stomas
Dr. John Marks, chair of colorectal surgery at Main Line Health and lead surgeon on the case, said the team’s first priority is still curing the cancer, but with an eye toward “giving the patient the highest quality of life.” Marks and his surgical partner are currently the only surgeons in the region participating in the Colovac trial. Lankenau Institute for Medical Research president George Prendergast called the effort “one of the most exciting developments” at LIMR, in a statement to Main Line Health.
What This Could Mean For Patients
An estimated 18 635% of colorectal cancer survivors receive a temporary or permanent ostomy, a burden that advocates and surgeons say weighs heavily on quality of life and can make recovery more complicated, according to the Colorectal Cancer Alliance. The SAFE-3CV trial is designed to compare outcomes for patients treated with Colovac against historical controls in order to see whether the internal bypass can consistently protect a colorectal anastomosis during the critical early healing period.
Next Steps
Lankenau will keep enrolling eligible patients under the SAFE-3CV protocol while additional U.S. centers join the study. SafeHeal says it expects enrollment to wrap up by late 2026, positioning the trial as the final step before the company submits a U.S. market application. Technical details and the trial registration are publicly listed on ClinicalTrials.gov and in the company’s study announcement for readers who want to dive into enrollment criteria and participating sites.
