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:
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
|SOURCE PEAK Surgical|
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