First-of-its-Kind Natural Orifice Surgical Procedure Performed Using Power Medical...
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First-of-its-Kind Natural Orifice Surgical Procedure Performed Using Power
Medical Interventions(r) Intelligent Surgical Instruments(tm)
LANGHORNE, Pa., March 30, 2009 (GLOBE NEWSWIRE) -- Power Medical
Interventions(r), Inc. (Nasdaq: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 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, 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.
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CONTACT: Power Medical Interventions, Inc.
Brian M. Posner, Chief Financial Officer
267-775-8100
Vida Communication
Tim Brons (media)
415-675-7402
tbrons@vidacommunication.com
Stephanie Diaz (investors)
415-675-7401
sdiaz@vidacommunication.com
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