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FDA approves new device for endolumenal procedures
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The FDA has approved a device designed to create a stabilized therapeutic zone in the colon during endolumenal procedures.
The DiLumen C² (Lumendi) helps ensure the correct positioning of an endoscope and assists with visualization, diagnosis and endoscopic treatment, according to a press release issued by the manufacturer.
“We are continuing our commitment to develop innovative devices that facilitate endolumenal procedures for many gastrointestinal interventions in an effort to reduce costs and improve patient outcomes,” Peter Johann, PhD, CEO of Lumendi said in the press release. “To date, we have completed over 350 procedures with the commercially available DiLumen EIP with no serious adverse events. Three clinical studies have also been completed, further demonstrating safety and cost effectiveness.”
Like its predecessor, the DiLumen EIP, the new device has two balloons that help with stabilization during endolumenal procedures. The DiLumen C² also includes two 6-mm diameter tool channels, which can hold two independent flexible articulating hand instruments, according to the press release.
Lumendi said the device will help clinicians perform complex procedures on the colon without open surgery.
The company expects studies on the devices to be published soon.
Disclosures: Johann is employed by Lumendi.