PEAK Surgical, Inc., a medical device company that has developed a new tissue dissection system based on a proprietary technology, announced that it has received European CE Mark approval for its PEAK® Surgery System for use in general surgery. The PEAK Surgery System includes the PULSAR™ Generator and the PEAK PlasmaBlade™ family of disposable, low-temperature surgical cutting and coagulation devices. The generator provides pulsed plasma radiofrequency energy to the PlasmaBlade to incise tissue and control bleeding.
PEAK Surgical received 510(k) clearance from U.S. Food and Drug Administration (FDA) in July 2008 for the PEAK Surgery System for use in general surgery and in December 2008 for cutting and coagulation of soft tissue during plastic and reconstructive, ENT (ear, nose and throat), gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures. To date, surgeons in the United States have used the PlasmaBlade in more than 500 surgical procedures, including in general, gynecologic, cardiothoracic and plastic and reconstructive surgeries.
“We are pleased that the European authorities have approved the use of the PEAK Surgery System. We continue to receive positive feedback from surgeons in the United States. They not only find the PlasmaBlade to be intuitive and easy to use, but also to precisely cut tissue and control bleeding without extensive collateral thermal damage to tissues,” said John Tighe, president and chief executive officer of PEAK Surgical. “We look forward to commercializing this innovative device in Europe, where we believe the PlasmaBlade could eventually be used in more than 1 million surgical procedures each year.”
PEAK Surgical recently 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, gynecologic and oncologic surgery.
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.
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 device. 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- 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.
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.