Power Medical Interventions Receives FDA Clearance for i45V

LANGHORNE, Pa.— Power Medical Interventions®, Inc. (Nasdaq:PMII), a leader in developing and commercializing Intelligent Surgical Instruments™, announced that the Food and Drug Administration (FDA) has cleared its 510(k) application for marketing its patented i45V Intelligent Surgical Instrument™ and 45mm vascular (white) reload cartridge. The i45V Intelligent Surgical Instrument is a reusable, autoclavable linear stapler designed for use in endoscopic surgery and the emerging field of NOTES. The i45V will have applications in occlusion of vascular structures in minimally invasive general, gynecological, urologic, thoracic, and colon and rectal surgical procedures for transection and occlusion of vascular structures. The company intends to launch the product in early August.

Michael Whitman, president and chief executive officer, commented, "We are excited to have received clearance from the FDA to market the world's first computer-assisted endoscopic vascular linear cutter. The i45V further expands our line of Intelligent Surgical Instruments and underscores PMI's ability to respond to the markets' increasing demand for enabling and innovative instruments for minimally invasive surgery. The i45V stapler and reloads have indications for use in thoracic surgery, OB/GYN surgery, and on a wide range of other vascular structures throughout the circulatory system. This product will enable us to continue to meet our customers' request to bring to market new products that provide increased precision and consistency and address an even wider array of minimally invasive surgical applications. The i45V, as are all of PMI's Intelligent Surgical Instruments, is eco-friendly, being reusable and recyclable. Technological advancements in materials and design allow PMI's engineers to create Intelligent Surgical Instruments that are able to be sterilized in an autoclave, with only water as a waste byproduct. This allows our instruments to be reused between 500 and 1,500 times, making them not only eco-friendly, but cost effective. PMI continues to be committed to reducing medical waste and the associated negative impact on the environment to near zero levels."

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.

Source: Power Medical Interventions