PEAK Surgical Introduces PEAK PlasmaBlade(TM) TnA

Main Category: Ear, Nose and Throat
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 05 Aug 2009 - 0:00 PDT


PEAK Surgical, Inc. announced the launch of the PEAK((R)) PlasmaBlade TnA (Tonsil and Adenoid) tissue dissection device following 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new product is indicated for cutting and coagulation of soft tissue during otolaryngology (ear, nose and throat [ENT]) surgery, including removal of the tonsils and adenoids.

"Having tried all of the energy-based device options on the market for tonsillectomy and adenoidectomy, I have found the PlasmaBlade TnA to be the first device that can effectively address both procedures," said Brian H. Weeks, M.D., otolaryngologist at Alvarado Hospital and Director of Minimally Invasive Head & Neck Surgery at SENTA clinic in San Diego. "The PlasmaBlade TnA not only cuts and cauterizes tissue precisely but the reduced thermal damage to surrounding healthy tissue has translated into clinical benefits for my patients."

"I have found the PlasmaBlade TnA to be an excellent precision dissection instrument that was specifically designed with the surgeon who does a lot of tonsillectomy and adenoidectomy in mind," said Kay Chang, M.D., associate professor of otolaryngology at Stanford University School of Medicine. "To date, my patients have experienced excellent post-operative recoveries, which I believe is due to the reduced thermal injury profile of this device."

The PEAK PlasmaBlade((TM)) is a family of disposable, low-temperature surgical cutting and coagulation devices that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without the extensive collateral damage to surrounding tissue. The PlasmaBlade is part of the PEAK(R) Surgery System, which also includes the PULSAR((R)) Generator. The generator provides pulsed plasma radiofrequency energy to the PlasmaBlade to incise tissue and control bleeding. In the United States, the PEAK Surgery System is cleared for use in general, plastic and reconstructive, ENT, gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures. It was launched in the United States in July 2008 and has been used by U.S. surgeons on more than 2,000 patients, including general, gynecologic, and plastic and reconstructive surgeries.

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 evaluate the use of the PEAK Surgery System in plastic and reconstructive, ENT and oncologic surgery. Initial study results are expected later this year.

"An estimated 600,000 tonsillectomies are performed in the United States each year, many of which are accompanied by an adenoidectomy. Given the clinical benefits of the PlasmaBlade TnA, we expect to quickly capture a significant share of this market," said John Tighe, president and chief executive officer of PEAK Surgical. "We have already seen significant adoption of the PlasmaBlade for the existing indications by U.S. surgeons, and more recently by European surgeons, and are confident in the potential of this new market."

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(R) 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.

Source: PEAK Surgical, Inc

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