Colospan announced today that it won FDA investigational device exemption for its CG-100 temporary intraluminal bypass device for gastrointestinal resection procedures.
Following the IDE win, Israel-based Colospan plans to launch its pivotal study for the CG-100 device, which is designed to reduce diverting stoma rates in patients undergoing those resection procedures.
In comparison to diverting stoma that is usually deployed for four-to-six months and requires a second surgery for removal, the CG-100 is meant to be deployed for just 10 days and includes easy removal under X-ray without the need for a second surgery, according to a news release.
Colospan intends to launch its prospective, randomized pivotal study in the first quarter of 2020. It is slated to be conducted across the U.S. and Europe to support future regulatory approval efforts in the U.S.
“We are pleased to have received FDA approval of our IDE application and we look forward to initiating the pivotal study which is a leap forward towards bringing our novel device closer to the market,” Colospan CEO Boaz Assaf said in the news release. “The pivotal study will allow us to assess the potential of our device to improve patients’ lives, significantly reduce healthcare costs and as a result empower physicians to deliver an improved standard of care. This is a significant milestone for our company as we advance the clinical development of our novel technology in the U.S.”
Original Article: (https://www.massdevice.com/colospan-wins-ide-fda-approval-for-intraluminal-bypass-device/)