PEAK Surgical, Inc. 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)
Published: Apr 07, 2009
* Completion of the first clinical study in the series known as the PRECISE (Pulsed Plasma Radiofrequency Energy to ReduCe Thermal Injury and Improve Surgical HEaling) Clinical Study series evaluating improved surgical incision healing following use of the PEAK Surgery System in plastic and reconstructive, gynecologic and oncologic surgeries. The PRECISE abdominoplasty ("tummy tuck") study, a prospective, randomized, controlled superiority study of 20 patients, examined chronic wound healing, post-operative pain, drain output, scarring and return to normal activity, and was conducted at El Camino Hospital in Mountain View, Calif. PEAK Surgical expects to present trial results at several upcoming medical conferences.
* Receipt of a 2009 Medical Design Excellence Award (MDEA) for the PEAK Surgery System. The award recognizes advances in the design of medical products and evaluated entries on their design and engineering features, including innovative use of materials, user-related functions that improve healthcare delivery and change traditional medical attitudes or practices, and features that provide enhanced patient benefits.
* Use of the PlasmaBlade by U.S. surgeons on more than 1,000 patients, including in general, gynecologic, and plastic and reconstructive surgeries.
"Despite the current financial climate in which hospitals and clinics are cutting back their spending on surgical devices and patients are postponing elective procedures, we have seen significant uptake of the PlasmaBlade by surgeons," said John Tighe, president and chief executive officer of PEAK Surgical. "The fact that in just eight months, more than 1,000 patients have undergone surgical procedures with the PlasmaBlade is a testament to the benefits the technology provides to surgeons and patients, including improved surgical incision healing, minimal bruising, scarring and inflammation."
"The PlasmaBlade technology has been extensively validated through preclinical data, and I expect that the comprehensive clinical study program under way will confirm the positive patient outcomes we are seeing clinically," said Dr. Howard Rosenberg, former chief of surgery at El Camino Hospital in Mountain View , Calif., and co-primary investigator of the PRECISE abdominoplasty study.
Since the PEAK Surgery System was cleared by the U.S. Food and Drug Administration for use in general surgery and launched in July 2008 in the United States, PEAK Surgical has achieved several other milestones, including:
* Introduction of two new products in the PlasmaBlade family, including the PlasmaBlade Needle, specifically designed for ultra-precise surgical procedures, and the PlasmaBlade EXT, designed for use in surgical procedures requiring an extended-reach tip; * Receipt of 510(k) clearance for the PEAK Surgery System to expand the indications to include cutting and coagulation of soft tissue during plastic and reconstructive, ENT (ear, nose and throat), gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures; * Receipt of European CE Mark approval for the PEAK Surgery System for use in general surgery.
Benefits of the PlasmaBlade and PULSAR Generator
For decades, surgeons have relied on scalpels to cut skin and delicate tissues and have 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 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 electrosurgical device for coagulation.
The PlasmaBlade family of devices offers the precision of a scalpel and the bleeding control of a traditional electrosurgery device in a single surgical instrument. The PlasmaBlade family includes the PlasmaBlade 4.0, which is designed to be used to cut through all types of soft tissue, including skin, fat and muscle; the PlasmaBlade Needle, which has a fine needlepoint tip and is specifically designed for ultra-precise surgical procedures; and the PlasmaBlade EXT, which is designed for use in surgical procedures requiring an extended-reach tip.
Unlike most radiofrequency-based surgical products that use continuous voltage waveforms to cut tissue, the PULSAR Generator supplies pulsed plasma radiofrequency energy to the PlasmaBlade to incise tissue and control bleeding. Because the radiofrequency energy is provided through short on-and-off pulses via a highly insulated cutting electrode, the PlasmaBlade cuts at half the average temperature of a conventional electrosurgery device and can be as low as 50 degrees Centigrade. This temperature reduction results in significantly less damage to surrounding tissues compared to traditional electrosurgery. The PlasmaBlade is also able to dissect tissue in a completely submerged surgical field, another shortcoming of traditional electrosurgical devices.
Preclinical results have demonstrated that the PlasmaBlade is associated with effective bleeding control, minimal thermal tissue injury, reduced scarring and inflammation, and improved surgical incision healing and strength compared with traditional electrosurgical or electrocautery devices.
PEAK Surgical's pulsed plasma-mediated discharges and electrode insulation techniques were originally invented at the Hansen Experimental Physics Laboratory and Department of Ophthalmology at Stanford University and developed by PEAK Surgical.
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 important advance in radiofrequency surgical technologies. The PEAK Surgery System consists of the PEAK PlasmaBlade(TM), 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(TM) 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 EU. For more information, please visit www.peaksurgical.com.