Healthcare Industry News: intended use
News Release - July 8, 2008
Power Medical Interventions, Inc. Files Special 510(k) for i45V 45mm Vascular Stapler and Reload CartridgeLANGHORNE, Pa., July 8, 2008 (Healthcare Sales & Marketing Network) -- Power Medical Interventions(r), Inc. (NasdaqGM:PMII ), a leader in developing and commercializing Intelligent Surgical Instruments(tm), announced today that it has submitted a special premarket notification, or Special 510(k), to the U.S. Food and Drug Administration (FDA) for regulatory clearance for its i45V Intelligent Surgical Instrument(tm) and 45mm vascular (white) reload cartridge. The i45V Intelligent Surgical Instrument(tm) is a reusable, autoclavable linear stapler designed for use in endoscopic surgery and the emerging field of NOTES. The i45V, once cleared, 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's Special 510(k) notification also covers the 45mm white reload cartridges that are designed to be used with the i45V stapler. Reload cartridges are the ``razor blades'' to the Intelligent Surgical Instrument ``razors'' in the company's recurring revenue business model, and the company expects that sales of reloads will become its largest source of revenue.
Michael Whitman, President and Chief Executive Officer, commented, ``The filing of the Special 510(k) of the i45V Intelligent Surgical Instrument and 45mm Vascular reloads marks the completion of our developmental stage of our vascular Intelligent Surgical Product Line. When cleared, the i45V will expand our ability to meet our customer's request that we become a full line supplier of surgical stapling instruments. PMI's i45V stapler and reloads are designed for use on pulmonary arteries and veins and other vascular structures throughout the circulatory system. We now expect to be able to support a wider array of surgical applications in both our current customer base and in our targeted customer base.''
PMI's Intelligent Surgical Instruments(tm) 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(tm) offer greater precision and consistency, superior compressive force, improved access to anatomical sites and enhanced ease of use.
A Special 510(k) is submitted for a modification to an existing device that has been previously cleared for marketing under the 510(k) process. If the modification does not affect the intended use of the device or alter the fundamental scientific technology of the device, then summary information that results from the design control process can serve as the basis for clearing the application. The FDA's Office of Device Evaluation (ODE) and Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) generally processes Special 510(k)s within 30 days of receipt, the company said, although there can be no assurance that clearance for the i45V device will be obtained within that time frame.
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 http://www.pmi2.com.
Safe Harbor Statement
Statements included in this press release, which are not historical in nature, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements relating to the future financial performance of the Company are subject to many factors including, but not limited to, the customer acceptance of the products in the market, the introduction of competitive products and product development, commercialization and technological difficulties, and other risks detailed in the Company's Securities and Exchange Commission filings, including the Company's Annual Report on Form 10-K for the year ended December 31, 2007 and its Quarterly Report on Form 10-Q for the three months ended March 31, 2008.
Such statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. When used in this press release the terms ``anticipate,'' ``believe,'' ``estimate,'' ``expect,'' ``may,'' ``objective,'' ``plan,'' ``possible,'' ``potential,'' ``project,'' ``will'' and similar expressions identify forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof, and we do not undertake any obligation to update any forward-looking statements, whether as a result of future events, new information or otherwise.
Source: Power Medical Interventions
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