Lumendi said today it won FDA 510(k) clearance for its DiLumen IS endolumenal interventional scissors, now indicated for cutting, dissecting and cauterizing tissue within the digestive tract during endoscopic procedures.
The Westport, Conn.-based company touted the sterile, single-use disposable, monopolar electrosurgical device as the fourth it’s developed, and said that it and its recently cleared DiLumen CT are intended to help improve access and therapy in the colon and reduce the need for surgical interventions.
The recently cleared C2 is a second-gen Endolumenal interventional platform designed to ensure complete positioning of an endoscope in the large intestine while also assisting with optical visualization, diagnosis and endoscopic treatment, the company said.
“The DiLumen platform of devices, now complemented by DiLumen Is, is designed to further facilitate and improve technically difficult and time-consuming endoscopic interventions for colonic lesions, such as polyps, a common condition that affects millions worldwide, and may replace invasive open surgical or laparoscopic procedures for patient benefit and potentially reducing healthcare costs,” CEO Dr. Peter Johann said in a press release.
Lumendi said that to date, its DiLumen EIP system has been used in more than 400 procedures with no reports of serious adverse device related adverse events, and added that three studies of the device have been completed with publication dates in the near future.
