Navigation Links
PEAK Surgical Announces Results of First PRECISE Studies at American College of Surgeons' Clinical Congress
Date:10/14/2009

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


'/>"/>
SOURCE PEAK Surgical
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:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... in the ECG Cables And ECG Leadwires Market owing to ... devices. On the other hand, the Asia-Pacific ... rate during the forecast period. The market players ... plc ( Ireland ), Koninklijke Philips N.V. ( ... ( China ), held major share of the ...
(Date:12/2/2016)... PUNE, India , December 2, 2016 /PRNewswire/ ... research report "In Vitro Diagnostics/IVD Market by Product ... Diagnostics, Hematology), Application (Diabetes, Oncology, Cardiology, Nephrology, Infectious ... the global market is valued at USD 60.22 ... grow at a CAGR of 5.5% during the ...
(Date:12/2/2016)... On Thursday, December 1st 2016, ... research, development and innovation in the biopharmaceutical industry at ... in the presence of Sergey Tsyb, Vice Minister of ... , Natalia Sanina, First Vice Chairman of the ... of Roszdravnadzor, National Service of Control in Healthcare, Sergey ...
Breaking Medicine Technology:
(Date:12/2/2016)... Milford, NJ (PRWEB) , ... December 02, 2016 , ... ... Nothing Water has some unique properties including its unmatched natural purity of just 6 ... as clean and crisp. , Nothing Water has been available in several ShopRite and ...
(Date:12/2/2016)... ... December 02, 2016 , ... Clarify Health ... has raised $6.0 million in an initial round of funding. The round was ... and their caregivers can receive far better care through the application of the ...
(Date:12/2/2016)... ... December 02, 2016 , ... ‘Tis the season for giving! Today, 20 ... the National Family Partnership and the Drug Enforcement Administration as part of the National ... the 10 winning schools who decorated their campuses with this year’s Red Ribbon Week ...
(Date:11/30/2016)... PALMYRA, Wisconsin (PRWEB) , ... November 30, 2016 ... ... inclusion in the 2016 Deloitte Wisconsin 75, an annual ranking and recognition of ... consecutive year on the list, having ranked from 2008-2016. In addition, Standard Process ...
(Date:11/30/2016)... ... November 30, 2016 , ... ... and stylish design wanted by today’s consumers at an affordable price, is now ... says the new watch is “a game changer” when it comes to the ...
Breaking Medicine News(10 mins):