Healthcare Industry News: left atrial appendage
News Release - December 21, 2007
Power Medical Interventions, Inc. Receives FDA 510(k) Marketing Clearance for iDrive Intelligent Surgical InstrumentsSelf-Contained, Hand-Held Control Unit Combines With Existing Digital Loading Units for Use in Open and Minimally Invasive Surgery
LANGHORNE, Pa., Dec. 21, 2007 (Healthcare Sales & Marketing Network) -- Power Medical Interventions(r), Inc. (NasdaqGM:PMII ), a leader in developing and commercializing Intelligent Surgical Instruments(tm), announced today that the U.S. Food and Drug Administration has cleared its 510(k) application for marketing its patented iDrive surgical devices. The iDrive family of devices is a suite of reusable, self-contained, hand-held devices that can be used to power and control PMI's existing suite of Digital Loading Units(tm), including linear cutter, right-angle linear cutter, and circular staplers. The Company's first generation of technology, the SurgASSIST(r), required the use of an external power console, flexible drive shaft and separate remote control unit. These functions can now be performed by a single hand held iDrive unit. The iDrive has been cleared for a broad range of applications in open and endoscopic surgery. These applications have indications for gastrointestinal, gynecological, general abdominal, thoracic and vascular surgical procedures for resection, transection, creation of anastomoses and for open occlusion of the heart's left atrial appendage.
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. Compared to conventional endomechanical devices, PMI believes that its Intelligent Surgical Instruments(tm) offer greater precision and consistency, superior compressive force, improved access to anatomical sites and enhanced ease of use. PMI's Intelligent Surgical Instruments(tm) have been used in thousands of surgical procedures.
The iDrive is the latest addition to the Intelligent Surgical Instruments(tm) family and follows the recently launched i60, our 60 mm articulating endoscopic linear cutter. These next generation products are controlled by direct-drive motors, motor-control circuits and clinician-feedback technology that have been miniaturized and integrated into a self-contained, hand-held unit. These instruments are operated with digital controls located in the handle and do not require an AC power source. Intelligent Surgical Instruments(tm) are powered by proprietary lithium ion batteries.
At the push of a button, the iDrive can effect a sequence of steps under software control that enables linear cutter, right-angle or circular staplers to be deployed with precision and control while maintaining stability at the surgical site. The iDrive is reusable and autoclavable and can operate a variety of Digital Loading Units(tm), all offering the benefits of computer-mediated stapling. PMI believes that iDrive is an important technology innovation in the field of surgery that will improve stapling performance and ease of use.
Michael Whitman, Founder, President and Chief Executive Officer commented, ``The FDA clearance of the iDrive is the latest addition of our expanding family of Intelligent Surgical Instruments(tm). The iDrive will allow PMI customers to forgo the use of our external power console and two-meter long flexible shaft previously required for operation of our Digital Loading Units(tm). We recognized that the need for this additional equipment was limiting our market penetration. PMI developed Intelligent Surgical Instruments(tm) in response to our surgeon customers' feedback on our breakthrough SurgASSIST(r) design. We believe that the iDrive and the recently launched i60 will exceed our surgeon customers' expectations and combine to make a powerful one-two punch in the market. PMI is committed to continuing to pioneer this exciting new technology platform for use in both open and laparoscopic surgery. Other Intelligent Surgical Instruments(tm) are being developed for use in the emerging field of Natural Orifice Translumenal Endoscopic Surgery (NOTES(tm)). We are very excited about the prospects of our Intelligent Surgical Instruments(tm)''
About Power Medical Interventions, Inc.:
Power Medical Interventions(r), Inc. is an integrated medical device company and 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.
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.
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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