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PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in Expanded Indications

Posted on: Wednesday, 17 December 2008, 07:00 CST

PALO ALTO, Calif., Dec. 17 /PRNewswire/ -- PEAK Surgical, Inc., a medical device company that has developed a new tissue dissection system based on a proprietary technology, announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its PEAK(R) Surgery System for cutting and coagulation of soft tissue during plastic and reconstructive, ENT (ear, nose and throat), gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures. The company also announced that it has initiated a series of clinical studies, called the PRECISE Studies (Pulsed Plasma Radiofrequency Energy to ReduCe Thermal Injury and Improve Surgical HEaling), to evaluate the use of the PEAK Surgery System in plastic, gynecologic and oncologic surgery.

The PEAK Surgery System, which received FDA clearance for use in general surgery in July 2008, includes the PEAK PlasmaBlade(TM) family of disposable surgical cutting and coagulation devices. The PlasmaBlade tissue dissection devices are used in conjunction with PEAK's PULSAR(TM) Generator, which provides pulsed plasma radiofrequency energy to the PlasmaBlade to incise tissue and control bleeding. The PlasmaBlade offers the exacting control of a scalpel and the coagulation of traditional electrosurgery without causing extensive collateral damage. Since FDA clearance, surgeons in the United States have used the PlasmaBlade in nearly 350 surgical procedures, including in general, gynecologic, cardiothoracic and plastic and reconstructive surgeries.

"Because the PlasmaBlade cuts at a lower temperature than traditional electrosurgical devices, it reduces collateral tissue damage and scarring, which is important for patients undergoing plastic surgery procedures," said Dr. Howard L. Rosenberg, former chief of surgery at El Camino Hospital in Mountain View, Calif., and co-primary investigator of an ongoing clinical study evaluating the PlasmaBlade in abdominoplasty (or "tummy tucks"). "We expect that the clinical study underway at our hospital will demonstrate improved healing, reduced pain and less post-operative drain output (serous fluid) with the PlasmaBlade compared with electrosurgery."

"We have been impressed with the reduced tissue charring and the ability to work close to delicate and sensitive tissues with the PlasmaBlade, which is especially important in gynecologic procedures in which the bowel, ureter and ovaries are close by," said Dr. Fermin F. Barrueto, chief of endoscopy and pelvic reconstruction at Mercy Medical Center in Baltimore and primary investigator of an ongoing clinical study evaluating the PlasmaBlade in hysterectomies. "We expect that the clinical study we are conducting will show less collateral thermal injury to uterine tissue and less post operative pain, due to the lower temperature associated with the PlasmaBlade compared with traditional electrosurgery."

PRECISE Studies Launch Comprehensive Clinical Study Program

PEAK Surgical recently initiated two clinical studies in plastic and gynecologic surgery, with three additional studies in plastic, gynecologic and oncologic surgery planned. All will evaluate the operative performance and clinical results of the PlasmaBlade compared with traditional electrosurgery. Results from the five PRECISE Studies are expected in the first half of 2009.

"With the FDA clearance of expanded surgical indications and the initiation of our comprehensive clinical study program, PEAK Surgical is poised to drive adoption of the PlasmaBlade based on clinical outcomes," said John Tighe, chief executive officer of PEAK Surgical. "We have already seen significant adoption of the PlasmaBlade by U.S. surgeons, as they discover how easy it is to use and how precisely it cuts tissue and controls bleeding without causing extensive collateral thermal damage to tissues. We expect the results of our PRECISE Studies to further validate our preclinical results showing effective bleeding control, minimal thermal tissue injury, positive wound healing, minimal scarring and inflammation, and improved surgical incision healing and strength compared with traditional electrosurgical devices."

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 offers the precision of a scalpel and the bleeding control of a traditional electrosurgery device in a single surgical 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 energy is provided through short on-and-off pulses via a highly insulated cutting electrode, the PlasmaBlade cuts 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 significantly less damage to surrounding tissues compared to traditional electrosurgical devices. The PlasmaBlade is also able to 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.

About PEAK Surgical, Inc.

PEAK Surgical, Inc. is a medical device company that has developed the PEAK(R) 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. For more information, please visit http://www.peaksurgical.com.

SOURCE PEAK Surgical, Inc.

Source: PR Newswire

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