Medical Device Daily
In the world of medical technology the most unique product ideas are often born in the university setting. Such was the case for PEAK Surgical (Palo Alto, California), which just received FDA clearance of expanded surgical indications for its PEAK Surgery System.
The technology, designed to cut as precisely as a scalpel and control bleeding at a much lower temperature than traditional electrosurgical devices — therefore doing significantly less damage to surrounding tissues — was originally developed at the Hansen Experimental Physics Laboratory and department of ophthalmology at Stanford University (Stanford, California). The company was founded in 2006.
The company yesterday reported receiving FDA 510(k) clearance to market its PEAK 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 FDA cleared the system in July for general surgery (Medical Device Daily, July 25, 2008).
CEO John Tighe told MDD that the FDA clearance the company received in July for general surgery was a "somewhat limited indication." The expanded indications for the system — which includes the company's PlasmaBlade family of disposable surgical cutting and coagulation devices — significantly broadens the company's ability to market for specific indications.
With the expanded indications, Tighe said PEAK is targeting more than 2 million procedures in the U.S. alone.
"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," Tighe said. "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."
He added, "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."
The system includes the PEAK PlasmaBlade family of disposable surgical cutting and coagulation devices. The PlasmaBlade tissue dissection devices are used in conjunction with PEAK's Pulsar Generator, which is designed to provide 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, according to PEAK. Since FDA clearance, surgeons in the U.S. have used the PlasmaBlade in nearly 350 surgical procedures, including in general, gynecologic, cardiothoracic and plastic and reconstructive surgeries, the company noted.
"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 Howard Rosenberg, MD, former chief of surgery at El Camino Hospital (Mountain View, California), and co-primary investigator of an ongoing clinical study evaluating the PlasmaBlade in abdominoplasty (tummy tucks). "We expect that the clinical study under way 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 Fermin Barrueto, MD, chief of endoscopy and pelvic reconstruction at Mercy Medical Center (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," he said.
The company also said 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 system in plastic, gynecologic and oncologic surgery. It 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.
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, PEAK noted. 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. PEAK said its PlasmaBlade offers the best of both worlds — 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. PEAK said the PlasmaBlade also is able to dissect tissue in a wet or dry surgical field.