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

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


Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Breast-Specific Gamma Imaging Proves Cost-Effective for Pre-Surgical Planning of Patients with Known Cancer Diagnosis
2. LEDs To Completely Replace Halogen Lights in the European Surgical Market By 2014
3. PEAK Surgical and Medtronic Announce Global Distribution Agreement for the Ear, Nose, and Throat Market
4. ThromboGenics Completes Patient Enrolment in US Phase III Trial of Microplasmin for the Non-Surgical Treatment of Eye Disease
5. Study in the New England Journal of Medicine Shows Non-Surgical Treatment for Pre-Cancerous Condition of Esophagus is Effective and Reduces Risk for Cancer Development
6. Feldenkrais(R) Movement Institute Announces Simple Non-Surgical Solutions for Jaw and Facial Pain (TMJ)
7. PEAK Surgical Announces Completion of First PRECISE Clinical Study, Receipt of Medical Design Excellence Award for PEAK(R) Surgery System and Achievement of Over 1,000 Surgeries Using PEAK PlasmaBlade(TM)
8. Innocoll Announces Dosing of Last Patient in Second US Phase 3 Clinical Trial to Investigate GENTAMICIN SURGICAL IMPLANT for Prevention of Surgical Site Infections in Colorectal Surgery Patients
9. Innocoll Announces Dosing of Last Patient in US Phase 3 Clinical Trial to Investigate GENTAMICIN SURGICAL IMPLANT for Prevention of Surgical Site Infections in Cardiac Surgery Patients
10. Children and Orthopaedic Surgical Emergencies
11. Novel Product for Post Surgical Scar Formation Entering Clinical Development
Post Your Comments:
(Date:11/24/2015)... 24, 2015  In the pharmaceutical industry, companies want ... to quickly uncover new insights, tactics and strategies that ... --> However, organizations often find it ... and ensure that all rules and regulations are met ... major barrier to efficiently launching market research projects is ...
(Date:11/24/2015)... , 24 de noviembre de 2015 /PRNewswire/ ... Breathing Pacemaker System, se complace anunciar el nombramiento ... consultor clínico.   ... -   --> ... un fisiólogo y consultor en neonatología y cardiología ...
(Date:11/24/2015)... 24, 2015  DILON Diagnostics and GE Healthcare are ... for DILON to distribute GE,s Discovery NM750b Molecular Breast ... of this distribution agreement will provide Dilon,s experienced distribution ... system and is considered an initial step in an ... for clinicians and their patients. --> ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... , ... Cold Shoulder , LLC launched their Pro Vest, the latest version of their ... of $20,000 in under 10 hours. , The campaign, which will continue ... Vest to the market. , The PRO Vest provides consumers with a less expensive, one-size ...
(Date:11/24/2015)... ... ... Dr. Rodney E. Willey , has answered a new calling – to relieve snoring ... treatment for snoring and sleep apnea through oral appliance therapy. He is ... in the US, one of four in the Illinois area. , Dr. Willey’s ...
(Date:11/24/2015)... , ... November 24, 2015 , ... Bibliomotion ... and Detroit Taught Me about Reinvention and Diversity by Nancy M. Schlichting, ... suffer, with hospitals failing to adequately address the needs of patients and their families, ...
(Date:11/24/2015)... Miami, FL (PRWEB) , ... November 24, 2015 ... ... manufacturer and engineer of patented products, announces Innovative Blending, a household invention that ... go. , "The Juice & Smoothie Bars market is worth $2 billion," says ...
(Date:11/24/2015)... ... November 24, 2015 , ... World Patent Marketing , ... a cosmetic invention which offers a combination of natural essential oils to create ... is worth $3 billion annually," says Scott Cooper, CEO and Creative Director of ...
Breaking Medicine News(10 mins):