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October 20, 2019Cart

Business

by Fairfield County Business Journal
by FCBJ

FDA clearance for Westport-based Lumendi’s surgical device

The U.S. Food and Drug Administration has approved the DiLumen I(s) Endolumenal Interventional Scissors. The sterile, single-use, disposable, monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures is produced by Lumendi LLC, the Westport-based subsidiary of Lumendi Ltd., a medical device company headquartered in Buckinghamshire, U.K.

Image courtesy of Lumendi.

Lumendi said that the scissors are the fourth device it has developed as it seeks to advance minimally invasive endolumenal therapies.

The DiLumen I and another recently cleared device, the DiLumen C-2, will round out a complete platform of accessories intended to improve access and therapy in the colon and reduce surgical interventions. The DiLumen C-2 is a second-generation Endolumenal Interventional Platform (EIP) designed to provide complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment.

Lumendi also reported that, to date, clinicians have completed over 400 procedures with the commercially available DiLumen EIP with no serious device-related adverse events. Three clinical studies using the DiLumen EIP have also been completed, further demonstrating safety and cost effectiveness. The studies are expected to be published in the near future, the company said.