- Preclinical Study Results Presented at American College of Surgeons
Annual Clinical Congress -
PALO ALTO, Calif., Oct. 9 /PRNewswire/ -- PEAK Surgical, Inc., a medical device company developing novel radiofrequency tissue dissection instrumentation, today announced results from a preclinical study evaluating its PEAK Pulsed Plasma Technology in the healing of surgical incisions compared with standard electrosurgery and surgical scalpels. Results showed that the PEAK PlasmaBlade(TM), which uses pulsed plasma energy to create surgical incisions, efficiently cut tissue with minimal bleeding, tissue injury and scarring. The data were presented in an oral presentation at the American College of Surgeons 93rd Annual Clinical Congress in New Orleans by lead investigator Shang A. Loh, M.D., postdoctoral fellow in the Division of Plastic Surgery at Stanford University School of Medicine.
"The findings of this comparative surgical incision healing study are encouraging as they add to our understanding that the PEAK PlasmaBlade provides better wound healing than standard of care electrosurgical devices," said John Tighe, president and chief executive officer of PEAK Surgical. "Due to its ability to precisely cut tissue while controlling bleeding and minimizing thermal damage, PEAK PlasmaBlade has the potential to be used across a variety of surgical applications. We are committed to developing this high-precision, tissue dissection technology and bringing it to market as quickly as possible as a potential new alternative for surgeons to provide better surgical incision and improved outcomes for their patients."
Study Design and Results
In the study, full thickness skin incisions were made with a traditional electrosurgery scalpel, the PEAK PlasmaBlade and a standard scalpel blade. Incisions were made at days 0, 21, 28, 35 and 42, and bleeding was evaluated for 60 seconds post-incision. The wounds were then sutured to allow for healing. Digital photos of the wounds were taken every seven days to evaluate scarring based on a visual analog scale. Histological examination was conducted to evaluate healing and inflammatory response.
Results showed that bleeding for 60 seconds following incision was reduced by 60 percent in the PEAK wounds compared with the standard scalpel wounds (p=0.0001). Wound sections showed greatly reduced acute thermal damage from the PEAK PlasmaBlade compared with the traditional electrosurgery scalpel (p=0.02). At six weeks, results showed minimal scarring of the PEAK and standard scalpel incisions compared with significant scarring of the traditional electrosurgery incisions (p=0.02 and 0.03, respectively). There was no significant difference in tissue injury between the PEAK and scalpel incisions, and both were significantly better than the traditional electrosurgery incision at one week (p=0.015).
"These study findings demonstrate that, compared with standard surgical techniques, pulsed plasma radiofrequency energy is clearly a superior method for efficient tissue dissection with superior hemostasis and minimal thermal damage," said Dr. Loh.
About PEAK's Technology
For decades, surgeons have relied on scalpels to cut skin and delicate tissues and on electrosurgical devices to cut and coagulate fat and other thicker, tougher tissues. Although scalpels precisely cut tissue with minimal injury, they do not control bleeding. Electrosurgical devices, on the other hand, cut efficiently and control bleeding but can cause thermal damage to surrounding tissue.
PEAK Surgical's flagship surgical system, the PULSAR(TM) Surgery System, combines the PULSAR Generator, which provides unique pulsed plasma radiofrequency waveforms, with the PEAK PlasmaBlade, a highly insulated tissue dissection instrument, to enable precise cutting with bleeding control and minimal thermal damage. This technology provides the benefits of both traditional scalpel and electrosurgery approaches -- enabling surgeons to cut soft tissue precisely with little damage to surrounding tissues and to control bleeding. Preclinical studies have shown that this may provide significant benefits for both surgeons and patients, including increased procedure efficiency, lower infection rates, faster recovery, reduced scarring and stronger wound healing.
PEAK's technology was successfully evaluated by Stanford University researchers in ophthalmology trials, including in retinal and cataract surgery. Results of the clinical use of PEAK's technology have been published in several peer-reviewed journals, including Retina, Archives of Ophthalmology, Journal of Cataract & Refractive Surgery and the British Journal of Ophthalmology.
The PULSAR Surgery System is not yet available in the United States. The Company is in the process of filing pre-market notification with the U.S. Food and Drug Administration and is planning to conduct additional preclinical studies of the technology.
About PEAK Surgical
PEAK Surgical is a medical device company developing a next-generation tissue dissection system with distinct advantages over surgical instruments in standard use today. The Company is exploring applications of its PEAK(TM) Pulsed Plasma Technology in numerous surgical fields. For more information, please visit http://www.peaksurgical.com.
Abstract number SF2007-458. "Comparative Healing of Surgical Incisions Created by a Standard "Bovie," PEAK(TM) PlasmaBlade and Standard Scalpel Blade." Presented at the American College of Surgeons 93rd Annual Clinical Congress on Tuesday, October 9, 2007, in New Orleans.
|SOURCE PEAK Surgical, Inc.|
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