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

Wednesday, December 17, 2008 General News J E 4
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PALO ALTO, Calif., Dec. 17 PEAK Surgical, Inc., a medicaldevice company that has developed a new tissue dissection system based on aproprietary technology, announced today that the U.S. Food and DrugAdministration (FDA) has granted the company 510(k) clearance to market itsPEAK(R) Surgery System for cutting and coagulation of soft tissue duringplastic and reconstructive, ENT (ear, nose and throat), gynecologic,orthopedic, arthroscopic, spinal and neurological surgical procedures. Thecompany also announced that it has initiated a series of clinical studies,called the PRECISE Studies (Pulsed Plasma Radiofrequency Energy to ReduCeThermal Injury and Improve Surgical HEaling), to evaluate the use of the PEAKSurgery System in plastic, gynecologic and oncologic surgery.

The PEAK Surgery System, which received FDA clearance for use in generalsurgery in July 2008, includes the PEAK PlasmaBlade(TM) family of disposablesurgical cutting and coagulation devices. The PlasmaBlade tissue dissectiondevices are used in conjunction with PEAK's PULSAR(TM) Generator, whichprovides pulsed plasma radiofrequency energy to the PlasmaBlade to incisetissue and control bleeding. The PlasmaBlade offers the exacting control of ascalpel and the coagulation of traditional electrosurgery without causingextensive collateral damage. Since FDA clearance, surgeons in the UnitedStates have used the PlasmaBlade in nearly 350 surgical procedures, includingin general, gynecologic, cardiothoracic and plastic and reconstructivesurgeries.

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

"We have been impressed with the reduced tissue charring and the abilityto work close to delicate and sensitive tissues with the PlasmaBlade, which isespecially important in gynecologic procedures in which the bowel, ureter andovaries are close by," said Dr. Fermin F. Barrueto, chief of endoscopy andpelvic reconstruction at Mercy Medical Center in Baltimore and primaryinvestigator of an ongoing clinical study evaluating the PlasmaBlade inhysterectomies. "We expect that the clinical study we are conducting willshow less collateral thermal injury to uterine tissue and less post operativepain, due to the lower temperature associated with the PlasmaBlade comparedwith traditional electrosurgery."

PRECISE Studies Launch Comprehensive Clinical Study Program

PEAK Surgical recently initiated two clinical studies in plastic andgynecologic surgery, with three additional studies in plastic, gynecologic andoncologic surgery planned. All will evaluate the operative performance andclinical 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 theinitiation of our comprehensive clinical study program, PEAK Surgical ispoised to drive adoption of the PlasmaBlade based on clinical outcomes," saidJohn Tighe, chief executive officer of PEAK Surgical. "We have already seensignificant adoption of the PlasmaBlade by U.S. surgeons, as they discover howeasy it is to use and how precisely it cuts tissue and controls bleedingwithout causing extensive collateral thermal damage to tissues. We expect theresults of our PRECISE Studies to further validate our preclinical resultsshowing effective bleeding control, minimal thermal tissue injury, positivewound healing, minimal scarring and inflammation, and improved surgicalincision healing and strength compared with traditional electrosurgicaldevices."

Benefits of the PlasmaBlade and PULSAR Generator

For decades, surgeons have relied on scalpels to cut skin and delicatetissues and have used electrosurgical devices to cut and coagulate fat andother thicker, tougher tissues. Although scalpels precisely cut tissue, theydo not control bleeding. Electrosurgical devices, on the other hand, cutefficiently and control bleeding but cause extensive thermal damage tosurrounding tissue. In cases where the risk of collateral damage or scarringfrom electrosurgery is considered to be unacceptable, surgeons must use both atraditional scalpel for cutting and an electrosurgical device for coagulation.The PlasmaBlade offers the precision of a scalpel and the bleeding control ofa traditional electrosurgery device in a single surgical device.

Unlike most radiofrequency-based surgical products that use continuousvoltage waveforms to cut tissue, the PULSAR Generator supplies pulsedplasma-mediated electrical discharges through the PlasmaBlade. Because theradiofrequency energy is provided through short on-and-off pulses via a highlyinsulated cutting electrode, the PlasmaBlade cuts at an average temperaturethat is half that of a conventional electrosurgery device and can be as low as50 degrees Centigrade. This temperature reduction results in significantlyless damage to surrounding tissues compared to traditional electrosurgicaldevices. The PlasmaBlade is also able to dissect tissue in a wet or drysurgical field.

The pulsed plasma-mediated discharges and electrode insulation techniqueswere originally developed at the Hansen Experimental Physics Laboratory andDepartment of Ophthalmology at Stanford University.

About PEAK Surgical, Inc.

PEAK Surgical, Inc. is a medical device company that has developed thePEAK(R) Surgery System, a new tissue dissection system based on a proprietarytechnology that represents an important advance in radiofrequency surgicaltechnologies. The PEAK Surgery System consists of the PEAK PlasmaBlade(TM), afamily of disposable cutting devices that offer the exacting control of ascalpel and the bleeding control of traditional electrosurgery withoutextensive collateral damage, and the PULSAR(TM) Generator, which suppliespulsed plasma radiofrequency energy to the PlasmaBlade. The PEAK SurgerySystem is cleared for use in general, plastic and reconstructive, ENT,gynecologic, orthopedic, arthroscopic, spinal and neurological surgicalprocedures in the United States. For more information, please visithttp://www.peaksurgical.com.

SOURCE PEAK Surgical, Inc.
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