PALO ALTO, Calif., July 8 /PRNewswire/ -- PEAK Surgical, Inc. today announced the launch of the PEAK PlasmaBlade® 3.0S dissection device following 510(k) clearance from the U.S. Food and Drug Administration (FDA). This revolutionary product features a 3.0mm wide blade for even greater cutting precision, integrated suction for enhanced visibility, and a telescoping shaft that extends from 5.5 cm to 15 cm for improved surgical access. The PlasmaBlade 3.0S is cleared for use in general, plastic and reconstructive, ENT, gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures in the United States.
"I have found the PlasmaBlade 3.0S to be an excellent precision dissection instrument for my spine surgery procedures," said John Peloza, M.D., director of the Center for Spine Care in Dallas, Texas. "The PlasmaBlade 3.0S not only precisely cuts and cauterizes pathological tissue but the reduced thermal damage to surrounding healthy tissue has translated into clinical benefits for my patients."
"The access and visibility with the PlasmaBlade 3.0S is excellent," said Helson Pacheco-Serrant, M.D., director of Neurosurgical Specialists of El Paso in El Paso, Texas. "The speed with which I can perform precise dissections near sensitive structures without worrying about thermal spread is a real advantage to both me and my patients. To date, my patients have experienced excellent post-operative recoveries, which I believe is due to the reduced thermal injury profile of this device."
PRECISE Study Results
PEAK Surgical has initiated a series of clinical studies, called the PRECISE Studies (Pulsed Plasma Radiofrequency Energy to ReduCe Thermal Injury and Improve Surgical HEaling), to examine the use of the PlasmaBlade in orthopedic, plastic and reconstructive, ENT and oncologic surgery. Initial study results have been presented at various medical congresses, including American College of Surgeons (ACS) and American Society of Breast Surgeons (ASBS) and additional results are expected later this year. These study results have demonstrated that the PlasmaBlade was associated with significant improvements in the following endpoints as compared with the standard of care:
- 75 percent reduction in thermal injury depth (p=0.001)
- 31 percent reduction in inflammation (p = 0.06)
- 49 percent reduction in post-operative narcotic consumption (p=0.02)
- 65 and 42 percent stronger healed incision strength at 3 and 6 weeks, respectively (p < 0.001)
"The clinical and economic benefits of the PlasmaBlade are making a positive impact on the healthcare community," said John Tighe, president and chief executive officer of PEAK Surgical. "We continue to see significant adoption of the PlasmaBlade by surgeons and hospitals as more than 25,000 surgical procedures have been performed with the PlasmaBlade to date since its launch in July 2008."
About PEAK Surgical, Inc.
PEAK Surgical, Inc. is a medical device company that has developed the PEAK PlasmaBlade®, a new tissue dissection device based on a proprietary technology that represents an important advance in radiofrequency surgical technologies. The PlasmaBlades are 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. These surgical devices come together with the PULSAR® Generator, which supplies pulsed plasma radiofrequency energy to the PlasmaBlades, to form the PEAK® Surgery System. 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 EU. In the United States, the PEAK Surgery System was launched in July 2008 and has been used by U.S. surgeons on more than 25,000 patients. For more information, please visit www.peaksurgical.com.
SOURCE PEAK Surgical, Inc.