PEAK Surgical Receives 510(k) Clearance To Market PEAK(R) Surgery System For Use In General Surgery

PEAK Surgical, Inc., a
medical device company that has developed a new tissue dissection system
based on a proprietary technology, announced that the U.S. Food and
Drug Administration has granted the company 510(k) clearance to market its
PEAK(R) Surgery System for use in general surgery. The PEAK Surgery System
combines the PULSAR(TM) Generator, which supplies pulsed plasma
radiofrequency energy, with the PEAK PlasmaBlade(TM) 4.0, a low-temperature
surgical cutting and coagulation tool. This tissue dissection system will
be commercially available next month.



"With the introduction of the PlasmaBlade, general surgeons now have
access to a single surgical tool that cuts tissue as precisely as a scalpel
and controls bleeding as effectively as traditional electrosurgery without
causing extensive collateral thermal damage to tissues," said John Tighe,
chief executive officer of PEAK Surgical.



In preparation for the commercialization of the PEAK Surgery System,
the company launched a redesigned corporate Web site, which can be accessed
at peaksurgical. The Web site provides detailed information
about all of the components of the PEAK Surgery System, including a cart
and wireless foot switch, as well as video, a brochure, fact sheets,
product images, scientific literature and surgeon testimonials, among other
information.



Benefits of the PlasmaBlade and PULSAR Generator



For decades, surgeons have relied on scalpels to cut skin and delicate
tissues and 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 can 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 electrosurgery
device for coagulation. The PlasmaBlade combines into a single surgical
tool the precision of a scalpel and the bleeding control of a traditional
electrosurgery 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 is provided in short on-and-off pulses and the blade
contains highly insulated electrodes, the PlasmaBlade cuts tissue 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 reduced heat transfer and half the damage to
surrounding tissues compared with traditional electrosurgical devices. The
PlasmaBlade also can dissect tissue in a wet or dry surgical field.



The pulsed plasma-mediated discharges and electrode insulation
techniques were originally developed at the Hansen Experimental Physics
Laboratory and Department of Ophthalmology at Stanford University.
















"Surgeons typically must switch between a scalpel and a traditional
electrosurgery device depending on the surgical field and type of tissue
they are cutting," said Dr. Thomas M. Krummel, professor and chair of
surgery at Stanford University School of Medicine. "I believe the
PlasmaBlade has the potential to revolutionize the way surgery is performed
because it eliminates the need to change from one surgical tool to another
as a surgeon cuts through all types of soft tissue, including skin, fat and
muscle. It also has the ability to cut in a wet or dry surgical field, an
advancement over most electrosurgical tools in use today."



PlasmaBlade Study Results



Results of a preclinical surgical incision healing study of the
PlasmaBlade presented in an oral presentation at the American College of
Surgeons' Annual Clinical Congress in October 2007 demonstrated that it
efficiently cut tissue with effective bleeding control and minimal thermal
damage compared with standard surgical techniques. The PlasmaBlade reduced
bleeding by 60 percent compared with a scalpel, while providing the same
positive wound healing profile of minimal scarring and inflammation. In
addition, surgical incision healing and strength were significantly
improved with the PlasmaBlade compared with traditional electrosurgical
devices.



Additional preclinical studies of the PEAK Surgery System are underway.
PEAK Surgical is exploring the applicability of its technology across
numerous surgical fields beyond general surgery, including cardiothoracic,
gynecologic, plastic and reconstructive and neurosurgery. The company
believes the technology may have applications in more than 2 million
surgical procedures each year.



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 evolutionary leap in the
advancement of radiofrequency surgical technologies. The PEAK Surgery
System consists of the PEAK PlasmaBlade(TM) 4.0, a disposable cutting tool
that offers the exacting control of a scalpel and the bleeding control of
traditional electrosurgery without the extensive collateral damage, and the
PULSAR(TM) Generator, which supplies pulsed plasma radiofrequency energy to
the PlasmaBlade. The PEAK Surgery System is cleared for use in general
surgery in the United States. The company is exploring the applicability of
this technology across additional surgical fields, including
cardiothoracic, gynecologic, plastic and reconstructive, and neurosurgery.
For more information, please visit peaksurgical.


PEAK Surgical, Inc.

peaksurgical

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