PEAK Surgical Announces Results of First PRECISE Studies at American College of Surgeons' Clinical Congress

Wed Oct 14, 2009 6:45pm EDT
 
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PEAK Surgical Announces Results of First PRECISE Studies at American College
of Surgeons' Clinical Congress
-- Data Demonstrate Significant Improvements in Post-Operative Patient
Outcomes Due to Reduced Thermal Injury --

CHICAGO and PALO ALTO, Calif., Oct. 14 /PRNewswire/ -- PEAK Surgical, Inc.
today announced results from the first of its PRECISE Clinical Studies (Pulsed
Plasma Radiofrequency Energy to ReduCe Thermal Injury and Improve Surgical
HEaling) demonstrating that its PEAK PlasmaBlade® tissue dissection device is
associated with significant improvements in post-operative wound drainage,
narcotic consumption, thermal injury, wound strength and return to normal diet
volume compared with the standard of care.


The study results were presented at the American College of Surgeons (ACS)
95th Annual Clinical Congress in Chicago by senior investigator Dr. Geoffrey
Gurtner, Professor of Surgery, Division of Plastic & Reconstructive Surgery,
Stanford University Medical Center.


"The premise of the PRECISE studies is to more fully understand the impact of
reduced thermal injury in human tissue and how that translates to
post-operative recovery," said Dr. Gurtner. "These results, which build upon
preclinical results presented at ACS in 2007, provide further proof of the
improved patient outcomes provided by the reduced thermal output from the PEAK
PlasmaBlade."


PRECISE Abdominoplasty Study Design


PEAK Surgical has initiated a series of clinical studies, called the PRECISE
Studies to evaluate the use of the PEAK Surgery System in plastic and
reconstructive, obstetric, general, orthopedic and oncologic surgery.


Results presented at the ACS annual meeting are from the first of the PRECISE
Studies. This study is a prospective, randomized, single-blind controlled
study designed to determine if an improved thermal injury profile would affect
post-operative wound drainage, pain score and narcotic consumption, return to
normal activity level and diet volume, and post-operative complications.


The study enrolled 20 adult females who were randomized to undergo an
abdominoplasty (tummy tuck) with the PEAK PlasmaBlade or standard of care
(scalpel and traditional electrosurgery).


At six and three weeks prior to, and on the day of, surgery, comparison
full-thickness skin incisions were made on the patient's abdomen with a
scalpel, traditional electrosurgery and PEAK PlasmaBlade and closed with
sutures. The sutures were removed after seven days and, following
abdominoplasty, the healed incisions were submitted for strength testing and
histological analysis.


Post-operative drainage, narcotic consumption, patient-reported pain score,
activity level and diet volume were assessed for 10 days post-operatively.
Additional data were collected for operative time, scar width and adverse
events.


PRECISE Abdominoplasty Study Results
The PRECISE Abdominoplasty Study results demonstrated that the PEAK
PlasmaBlade was associated with significant improvements in the following
endpoints as compared with the standard of care:


    --  31 percent reduction in drainage output (p<0.05)
    --  49 percent reduction in post-operative narcotic consumption (p=0.02)
    --  35 percent improvement in diet volume over 10 post-operative days
        (p=0.02)
    --  75 percent reduction in thermal injury depth compared to traditional
        electrosurgery (p=0.001)
    --  65 and 42 percent stronger healed wound strength than traditional
        electrosurgery at 3 and 6 weeks, respectively (p < 0.001)

    --  Equivalent operative time to the standard of care (p=0.94)





Additional improvement was also demonstrated in activity level, pain score and
hemoglobin drop; however these improvements were only weakly significant
(p<0.10).


"We are very pleased with the results of this study and the durable way it was
designed and conducted. In the end, we believe the PlasmaBlade may provide a
cost benefit to patients, surgeons and hospitals by reducing pain and
improving healing compared to the standard of care.  We're looking forward to
continuing our research into how the PlasmaBlade can impact patient outcomes
in a positive manner," said John Tighe, president and CEO of PEAK Surgical.
"Additional studies in the PRECISE series are already underway to evaluate
similar hypotheses in mastectomy, breast reduction, oncologic margins and
orthopedic surgeries."


About PEAK Surgical, Inc. and the PEAK Surgery System


PEAK Surgical, Inc. is a medical device company that has developed the PEAK®
Surgery System, a new tissue dissection system based on a proprietary
technology that represents an important advance in radiofrequency surgical
technologies. The PEAK Surgery System consists of the PEAK PlasmaBlade®, a
family of disposable cutting devices that offer the exacting control of a
scalpel and the bleeding control of traditional electrosurgery without
extensive collateral damage, and the PULSAR® Generator, which supplies pulsed
plasma radiofrequency energy to the PlasmaBlade. The PEAK Surgery System is
cleared for use in general, plastic and reconstructive, ENT, gynecologic,
orthopedic, arthroscopic, spinal and neurological surgical procedures in the
United States, and for use in general surgery in the European Union. It was
launched in the United States in July 2008 and has been used by U.S. surgeons
on more than 8,000 patients, including general, gynecologic, and plastic and
reconstructive surgeries. For more information, please visit
www.peaksurgical.com.




SOURCE  PEAK Surgical

Jessica Volchok of WeissComm Partners, +1-415-518-7006,
jvolchok@wcpglobal.com, for PEAK Surgical

 

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