Power Medical Interventions, Inc. Receives FDA 510(k) Marketing Clearance for i60RL Intelligent Surgical Instruments(tm)
First-of-Its-Kind Instrument Provides Surgeons With Greater Access to Key Anatomical Sites
LANGHORNE, Pa., Feb. 17, 2009 (GLOBE NEWSWIRE) -- Power Medical Interventions(r), Inc. (Nasdaq:PMII), a leader in developing and commercializing Intelligent Surgical Instruments(tm), announced today that the U.S. Food and Drug Administration has cleared its 510(k) application for marketing its patented i60RL Intelligent Surgical Instrument. 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). GERD is a digestive disorder that affects the lower esophageal sphincter, the muscle connecting the esophagus with the stomach. It is estimated that millions of Americans are affected by this disease. 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.
Dr. Alverdy commented, "Gastroesophageal reflux disease or GERD affects millions of Americans annually. If the study is successful, it will support our belief that the i60RL will provide an effective minimally invasive treatment alternative for patients suffering from GERD."
Michael Whitman, President and Chief Executive Officer, commented, "The i60RL is the world's first reverse pivot linear cutter, providing surgeons with the ability to access difficult to reach anatomical sites. We believe that Dr. Alverdy and the four clinical sites to be selected to conduct this study will provide us with the data to help us to prove the effectiveness of this device and illustrate the numerous benefits it will bring to both surgeons and patients. It is anticipated that the procedure, utilizing the i60RL, may take as little as thirty minutes to complete and will serve as an alternative to widely used prescription drugs and invasive surgeries. The i60RL is a unique and proprietary addition to PMI's growing line of Intelligent Surgical Instruments and further validates the possibility for PMI's technology to facilitate the creation of new clinical indications in minimally invasive surgery."
PMI's Intelligent Surgical Instruments are computer-assisted, power-actuated endomechanical instruments that surgeons use for cutting, stapling and tissue manipulation in a variety of procedures in open surgery and minimally invasive surgery. The Company believes that compared to conventional endomechanical devices, its Intelligent Surgical Instruments offer greater precision and consistency, superior compressive force, improved access to anatomical sites and enhanced ease of use.
About Power Medical Interventions, Inc.
Power Medical Interventions(r), Inc. is the world's only provider of computer-assisted, power-actuated surgical stapling products. PMI's Intelligent Surgical Instruments(tm) enable less invasive surgical techniques to benefit surgeons, patients, hospitals and healthcare networks. PMI manufactures durable recyclable technology to reduce medical waste and help keep the planet clean. The company was founded in 1999, and is headquartered in Langhorne, PA with additional offices in Germany, France, and Japan. To learn more about Power Medical Interventions, Inc. and its products, please visit www.pmi2.com.
