Healthcare Industry News:  endoscopic surgery 

Devices Surgery FDA

 News Release - February 5, 2007

Abdominal Surgical Procedures Without Skin Incisions

Power Medical Interventions(R)' Natural Orifice Linear Cutter (NOLC) Brings Access, Precision, and Reach to Surgical Stapling and Cutting

Intelligent Surgical Instruments(TM) will Advance Laparoscopic & Natural Orifice Surgery: Less pain, No Scars and Fewer Post-operative Complications for Patients



LANGHORNE, Pa., Feb. 5 (HSMN NewsFeed) -- Power Medical Interventions®, Inc. (PMI), a leader in developing and commercializing Intelligent Surgical Instruments(TM), announced today that the U.S. Food and Drug Administration (FDA) has cleared the company's 510(k) application for marketing the Natural Orifice Linear Cutter (NOLC), which enables surgeons to perform procedures through the gastrointestinal tract (GI) without cutting or puncturing the skin of the abdominal wall. The NOLC should help advance laparoscopic surgery, as well as the emerging Natural Orifice Translumenal endoscopic surgery (NOTES) field. NOTES has been previously limited by the lack of small, precise, remotely controllable devices, which can effectively and predictably close internal incisions.

"The NOLC is a device that will enable surgeons to advance laparoscopic surgery and NOTES to improve patient outcomes by reducing the pain, recovery time and risk of wound infection associated with traditional surgical procedures," stated Ninh Nguyen, M.D., chief of the Division of Gastrointestinal Surgery at the University of California, Irvine Medical Center. "The NOLC allows us to maneuver through the GI tract, turn corners and close internal wounds with precisely-fired staples -- all without making an incision in the patient's abdomen. The NOLC is an essential surgical device for NOTES, as the older devices we use to close internal incisions are too bulky and do not allow access through the body's natural orifices."

PMI's NOLC combines a 12mm-wide surgical stapling device with a flexible shaft. Powered digital controls within the NOLC give the surgeon precise command of the stapling instrument at the end of the shaft, acting like a tiny robot to do remotely what surgeons have done previously with sutures and manual staplers.

"Our SurgASSIST(TM) flagship platform is already allowing surgeons to take laparoscopic surgery to the next level," said Michael Whitman, president, chief executive, and founder of Power Medical Interventions. "We expect the NOLC to have a positive impact on surgical practice in many procedures, including high-risk bariatric or 'weight loss' surgery where the ability to partition or 'shrink' the size of the stomach without incisions should reduce the rate of infection, pain, scarring and recovery time for many patients."

About Power Medical Interventions®

Power Medical Interventions (PMI) is leading the development and commercialization of Intelligent Surgical Instruments(TM) for bariatric, cardiothoracic, colorectal and general surgical applications. PMI's proprietary product platform, SurgASSIST, with over 100,000 firings globally, enables less invasive surgical techniques to benefit surgeons, patients, hospitals and healthcare networks, including minimizing the very expensive surgical waste. The Company was founded in 1999 and has corporate headquarters in Langhorne, PA, USA. To learn more about Power Medical Interventions and its products, please visit http://www.pmi2.com.



Source: Power Medical Interventions

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