Bovie Medical Receives 510K Clearance for Its Cool-Coag™ Generator and Open Handpiece
March 27 2017 - 8:00AM
Business Wire
Only Handpiece to Combine J-Plasma® Precision
with Full Power Coagulation Capabilities
Commercial Launch Scheduled in Second Half of
2017
Bovie Medical (NYSE:BVX) announced today that it has received
510K clearance from the FDA for a new J-Plasma® generator and
handpiece that incorporate Cool-Coag™ technology.
Cool-Coag™ is a new technology that combines the unique benefits
of J-Plasma®, namely increased precision with minimal thermal
spread, with standard monopolar coagulation and helium spray
coagulation capabilities, all in one handpiece. This allows the
surgeon to benefit from using a single device that offers the
greater control of tissue effect that J-Plasma® delivers, while
being able to switch to a monopolar or helium spray coagulation
mode with just the push of a button.
“The development of Bovie’s Cool-Coag™ technology is a direct
result of feedback from surgeons who have used our J-Plasma®
product for procedures that require greater coagulation capability,
specifically in the areas of gynecologic oncology and surgical
oncology,” said Robert L. Gershon, Chief Executive Officer. “The
unique flexibility of Cool-Coag™ enables the surgeon to use
J-Plasma® to perform the most delicate procedures, where precision
and low risk of injury to surrounding tissue are paramount and also
have the full power of monopolar coagulation to control, pinpoint
and diffuse bleeding as needed.”
“This new Cool-Coag™ technology has the potential to increase
usage of the J-Plasma® device in many of our most complex cancer
procedures. It combines J-Plasma®’s ability to be used close to
vital structures with minimal collateral damage and standard full
monopolar coagulation capability, all in one hand-held instrument.
Cool-Coag™ may also expand the use of J-Plasma® in additional
procedures and specialties,” said Dr. Dennis Chi, head of the
Ovarian Cancer Surgery at Memorial Sloan Kettering Cancer Center in
New York City.
“We are pleased with our ability to continue to provide
innovation that meets the needs of surgeons and are confident in
the substantial growth opportunity for J-Plasma® as we continue to
penetrate the market,” Mr. Gershon noted.
About Bovie Medical Corporation
Bovie Medical Corporation is a leading maker of medical devices
and supplies as well as the developer of J-Plasma®, a patented new
plasma-based surgical product for cutting and coagulation.
J-Plasma® utilizes a helium ionization process to produce a stable,
focused beam of ionized gas that provides surgeons with greater
precision, minimal invasiveness and an absence of conductive
currents through the patient during surgery. Bovie Medical
Corporation is also a leader in the manufacture of a range of
electrosurgical products and technologies, marketed through both
private labels and the Company’s own well-respected brands (Bovie®,
Aaron®, IDS™ and ICON™) to distributors worldwide. The Company also
leverages its expertise through original equipment manufacturing
(OEM) agreements with other medical device manufacturers. For
further information about the Company’s current and new products,
please refer to the Investor Relations section of Bovie Medical
Corporation’s www.boviemed.com.
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version on businesswire.com: http://www.businesswire.com/news/home/20170327005309/en/
Investor Relations:MBS Value PartnersLynn Morgen / Jane
Searle, 212-750-5800investor.relations@boviemed.com
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