MEDICAL DEVICE INNOVATION - Medical Device Daily

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PEAK gets FDA clearance,
initiates PRECISE studies
By AMANDA PEDERSEN
Medical Device Daily Staff Writer
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 2008 for general
surgery.
CEO John Tighe told Medical Device Daily 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
MEDICAL DEVICE INNOVATION 2010
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 postoperative
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
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