PEAK Surgical Receives 510(k) Clearance to Market PEAK® Surgery System for Use in General Surgery
PALO ALTO, Calif. (July 24, 2008) – PEAK Surgical, Inc., a medical device company that has developed a new tissue dissection system based on a proprietary technology, today announced that the U.S. Food and Drug Administration has granted the company 510(k) clearance to market its PEAK® Surgery System for use in general surgery. The PEAK Surgery System combines the PULSARTM Generator, which supplies pulsed plasma radiofrequency energy, with the PEAK PlasmaBladeTM 4.0, a low-temperature surgical cutting and coagulation tool. This tissue dissection system will be commercially available next month.
“With the introduction of the PlasmaBlade, general surgeons now have access to a single surgical tool that cuts tissue as precisely as a scalpel and controls bleeding as effectively as traditional electrosurgery without causing extensive collateral thermal damage to tissues,” said John Tighe, chief executive officer of PEAK Surgical.
In preparation for the commercialization of the PEAK Surgery System, the company launched a redesigned corporate Web site, which can be accessed at www.peaksurgical.com. The Web site provides detailed information about all of the components of the PEAK Surgery System, including a cart and wireless foot switch, as well as video, a brochure, fact sheets, product images, scientific literature and surgeon testimonials, among other information.
Benefits of the PlasmaBlade and PULSAR Generator
For decades, surgeons have relied on scalpels to cut skin and delicate tissues and used electrosurgical devices to cut and coagulate fat and other thicker, tougher tissues. Although scalpels precisely cut tissue, they do not control bleeding. Electrosurgical devices, on the other hand, cut efficiently and control bleeding but can cause extensive thermal damage to surrounding tissue. In cases where the risk of collateral damage or scarring from electrosurgery is considered to be unacceptable, surgeons must use both a traditional scalpel for cutting and an electrosurgery device for coagulation. The PlasmaBlade combines into a single surgical tool the precision of a scalpel and the bleeding control of a traditional electrosurgery device.
Unlike most radiofrequency-based surgical products that use continuous voltage waveforms to cut tissue, the PULSAR Generator supplies pulsed plasma-mediated electrical discharges through the PlasmaBlade. Because the radiofrequency is provided in short on-and-off pulses and the blade contains highly insulated electrodes, the PlasmaBlade cuts tissue at an average temperature that is half that of a conventional electrosurgery device and can be as low as 50 degrees Centigrade. This temperature reduction results in reduced heat transfer and half the damage to surrounding tissues compared with traditional electrosurgical devices. The PlasmaBlade also can dissect tissue in a wet or dry surgical field.
The pulsed plasma-mediated discharges and electrode insulation techniques were originally developed at the Hansen Experimental Physics Laboratory and Department of Ophthalmology at Stanford University.
“Surgeons typically must switch between a scalpel and a traditional electrosurgery device depending on the surgical field and type of tissue they are cutting,” said Dr. Thomas M. Krummel, professor and chair of surgery at Stanford University School of Medicine. “I believe the PlasmaBlade has the potential to revolutionize the way surgery is performed because it eliminates the need to change from one surgical tool to another as a surgeon cuts through all types of soft tissue, including skin, fat and muscle. It also has the ability to cut in a wet or dry surgical field, an advancement over most electrosurgical tools in use today.”
PlasmaBlade Study Results
Results of a preclinical surgical incision healing study of the PlasmaBlade presented in an oral presentation at the American College of Surgeons’ Annual Clinical Congress in October 2007 demonstrated that it efficiently cut tissue with effective bleeding control and minimal thermal damage compared with standard surgical techniques. The PlasmaBlade reduced bleeding by 60 percent compared with a scalpel, while providing the same positive wound healing profile of minimal scarring and inflammation. In addition, surgical incision healing and strength were significantly improved with the PlasmaBlade compared with traditional electrosurgical devices.
Additional preclinical studies of the PEAK Surgery System are underway. PEAK Surgical is exploring the applicability of its technology across numerous surgical fields beyond general surgery, including cardiothoracic, gynecologic, plastic and reconstructive and neurosurgery. The company believes the technology may have applications in more than 2 million surgical procedures each year.
About PEAK Surgical, Inc.
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 evolutionary leap in the advancement of radiofrequency surgical technologies. The PEAK Surgery System consists of the PEAK PlasmaBladeTM 4.0, a disposable cutting tool that offers the exacting control of a scalpel and the bleeding control of traditional electrosurgery without the extensive collateral damage, and the PULSARTM Generator, which supplies pulsed plasma radiofrequency energy to the PlasmaBlade. The PEAK Surgery System is cleared for use in general surgery in the United States. The company is exploring the applicability of this technology across additional surgical fields, including cardiothoracic, gynecologic, plastic and reconstructive, and neurosurgery. For more information, please visit www.peaksurgical.com.
