Healthcare Industry News: endoscopy
News Release - March 30, 2009
First-of-its-Kind Natural Orifice Surgical Procedure Performed Using Power Medical Interventions(r) Intelligent Surgical Instruments(tm)Surgeons Safely Remove Tumor Through Vagina
LANGHORNE, Pa., March 30, 2009 -- (Healthcare Sales & Marketing Network) -- Power Medical Interventions(r), Inc. (NasdaqCM:PMII ), a leader in developing and commercializing Intelligent Surgical Instruments(tm), announced today that surgeons in Japan used the company's surgical instruments to successfully remove a gastric submucosal tumor (SMT) through a patient's vagina. This novel procedure, known as a transvaginal NOTES(r) (Natural Orifice Translumenal Endoscopic Surgery) partial gastrectomy, was the fourth ever of its kind. All four of these procedures have been conducted by Kiyokazu Nakajima, M.D., and Toshirou Nishida, M.D., of Osaka University using Power Medical Interventions' (PMI's) Intelligent Surgical Instruments. A study reporting the results of the first two procedures has been accepted for publication in an upcoming edition of Surgical endoscopy, a leading peer-reviewed journal.
Unlike traditional and laparoscopic surgery, PMI's iNOLC (Intelligent Natural Orifice Linear Cutter) and i60XXL (Articulating Endoscopic Linear Cutter) instruments enabled these operations to be performed with only two minor abdominal incisions. As a result, all four patients had tumors successfully removed while experiencing minimal postoperative pain, requiring no medication and being able to walk the day following surgery.
``PMI's iNOLC and i60XXL Intelligent Surgical Instrument enabled us to safely remove a large gastric SMT through a natural orifice in the patient's body with minimal pain,'' stated Dr. Nakajima. ``These ground-breaking procedures, which are only possible using cutting-edge instruments such as the iNOLC and i60XXL, are providing significant benefits to patients and surgeons both during and after surgery. We believe that this approach has the potential to become the standard of care for patients with gastric SMTs.''
Traditional surgery requires a 15-cm incision in the abdomen. While advanced laparoscopic surgery techniques are less invasive than traditional surgery, they still require several 1-cm incisions in addition to a 4-cm incision to remove the diseased tissue. NOTES is a new, minimally invasive surgical approach that involves passing surgical instruments through one of the body's natural orifices, such as the mouth, vagina or rectum, to remove a diseased organ or tissue. Operating through the body's natural orifices offers the potential for minimizing, or potentially even eliminating, external incisions and scarring, thus potentially reducing recovery time, physical discomfort, and healthcare costs when compared to traditional and laparoscopic surgeries.
``This fourth transvaginal NOTES procedure provides further validation for PMI's Intelligent Surgical Instruments and continues to position PMI as the leading provider of innovative NOTES-enabling instruments to the surgical community,'' stated Michael Whitman, president and chief executive officer of PMI. ``We are committed to continuing to meet the evolving needs of surgeons and patients by optimizing and expanding our suite of Intelligent Surgical Instruments to enable a wide variety of novel NOTES procedures.''
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 iNOLC, a computer-assisted, power-actuated 45 mm linear stapling device incorporating a flexible shaft, is designed specifically to facilitate NOTES procedures by enabling surgeons to perform procedures through the gastrointestinal tract without cutting or puncturing the abdominal wall. The iNOLC has not been cleared for clinical use by the United States Food and Drug Administration or by Japanese regulatory authorities, and the cutting and stapling cartridges used in the procedure have not been cleared for clinical use by Japanese regulatory authorities, but each was used in these procedures pursuant to one-time compassionate use waivers under the surgeon's license and the University's relevant committee approval.
The i60XXL Intelligent Surgical Instrument is PMI's extra long Articulating Endoscopic Linear Cutter designed for use in NOTES procedures and bariatric surgical applications to transect, resect and anastomose tissue. It is controlled by drive motors, motor control circuits and clinician-feedback technology that have been miniaturized and integrated into the handpiece.
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.
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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, 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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