PEAK Surgical, Inc. announced the first use of its PEAK Surgery System by surgeons in the European Union, where the innovative tissue dissection system received its CE Mark in January.
Dr. Raul Pellini and Prof. Giuseppe Spriano, ear, nose and throat (ENT) surgeons at Istituti Fisioterapici Ospitalieri (National Cancer Institute) in Rome, performed head and neck surgeries in cancer patients using the PEAK PlasmaBlades. Additionally, Prof. Spriano hosted a head and neck surgical international course on May 20-21 that also included a live surgery using the PlasmaBlade.
The PlasmaBlades worked beautifully in the partial laryngectomy and parotid dissection we conducted, producing nearly bloodless procedures, said Dr. Pellini. We are very keen for our ENT colleagues to evaluate these innovative devices as we expect that their patients will experience similar positive outcomes.
Like their colleagues in the US, surgeons in Europe are providing positive feedback that the PlasmaBlade allows them to precisely cut tissue and control bleeding during a wide variety of surgical procedures without causing extensive collateral thermal damage to tissues, said John Tighe, president and chief executive officer of PEAK Surgical. We expect to see continued uptake of the PEAK Surgery System in Europe, where we believe the PlasmaBlade could eventually be used in more than one million surgical procedures annually.
The PEAK PlasmaBlade 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. The PlasmaBlade is part of the PEAK Surgery System, which also includes the PULSAR Generator. The generator provides pulsed plasma radiofrequency energy to the PlasmaBlade to incise tissue and control bleeding. In the US, 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 US in July 2008 and has been used by US surgeons on more than 1,000 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, gynecologic and oncologic surgery. Initial study results are expected later this year.
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. In addition, preclinical results have demonstrated that the PlasmaBlade is associated with improved fascia incision healing in