Power Medical Interventions Receives 510(k) FDA Marketing Clearance

Langhorne, PA - Power Medical Interventions, Inc. (PMI), a leader in developing and commercializing Intelligent Surgical Instruments, announced recently that the U.S. Food and Drug Administration has cleared its 510(k) application for marketing the i60 Intelligent Surgical Instrument, a patented, first-of-its-kind surgical instrument for open and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses and for open occlusion of the heart's left atrial appendage

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. PMI's Intelligent Surgical Instruments have been used in over 30,000 surgical procedures worldwide.

The i60 Intelligent Surgical Instrument is the first of PMI's next generation products, that is controlled by drive motors, motor control circuits and clinician-feedback technology that have been miniaturized and integrated into the handpiece. The instrument is operated with digital controls located in the handle. PMI's first generation of Intelligent Surgical Instruments requires a flexible shaft that connects the hand held surgical device to a power console. The i60 Intelligent Surgical Instrument does not require a power console or a flexible shaft.

At the push of a button, the i60 places four rows of medical grade titanium staples in tissue while simultaneously cutting between them. The i60 Intelligent Surgical Instrument also offers articulation capabilities that enable it to mimic the articulation of the human wrist, enabling surgeons to access difficult to reach anatomy. The Company expects these key technology improvements to allow for more flexible manipulation, enhanced dexterity and increased ease of use of its Intelligent Surgical Instruments.

Michael Whitman, Founder, President and Chief Executive Officer commented, "The i60 is the first of PMI's next generation of Intelligent Surgical Instruments. PMI is pioneering this exciting new technology platform for use in both open and laparoscopic surgery. The i60 and its derivatives are also being developed for the emerging field of Natural Orifice Translumenal Endoscopic Surgery."

SOURCE: Power Medical Interventions, Inc.