The FDA has given approval to Power Medical Interventions (Langhorne, PA) for the company’s i60RL articulating endoscopic linear cutter. This device is basically a modified version of the i60 we wrote about back in 2007. To clarify on the difference, and on the name, here’s what the company tells Medgadget:
“The i60 is different than the i60R(everse). Both are 60mm articulating endoscopic linear cutters, but the i60R opens up with a reverse pivot (i.e. at the distal end). The L is extraneous and stands for linear.”
From the announcement:
The i60RL Intelligent Surgical Instrument is the world’s first reverse pivot linear cutter, designed to improve medical outcomes by providing surgeons with greater access to important anatomical sites that are currently difficult to reach. The i60RL will be available for applications throughout the digestive tract. The Company intends to launch the product in April 2009.
In addition, PMI received approval from an Institutional Review Board to conduct a study on the effectiveness of the i60RL in the treatment of gastroesophageal reflux disease (GERD).
The study will be conducted at the University of Chicago and will be lead by John Alverdy, M.D., Professor of Surgery and Head of the Minimally Invasive Lab at the University of Chicago.
Press release: Power Medical Interventions, Inc. Receives FDA 510(k) Marketing Clearance for i60RL Intelligent Surgical Instruments(tm)
Power Medical Interventions, Inc homepage…
Flashback: The i60 Robotic Articulating Endoscopic Linear Cutter