Bovie Medical Receives 510K Clearance for its J-Plasma® Precise Flex Handpiece
May 08 2017 - 7:30AM
Business Wire
The Addition of the J-Plasma® Precise Flex rounds out Bovie
Medical’s J-Plasma® offering to include products designed for open
and minimally invasive surgical procedures, including laparoscopic
and robotic approaches.
Bovie Medical (NYSE MKT:BVX) announced today that it has
received 510K clearance from the FDA for a new J-Plasma® Precise
Flex handpiece. The J-Plasma® Precise Flex handpiece is designed to
be used in robotic-assisted procedures including those with
Intuitive Surgical’s da Vinci Surgical System. The J-Plasma®
Precise Flex includes Bovie Medical’s Cool-Coag™ 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.
The J-Plasma® Precise Flex handpiece has a flexible shaft that
can be controlled with graspers, forceps or grasping instruments
and was designed to be used through an accessory port. When used in
robotic-assisted procedures, the J-Plasma® Precise Flex can be
controlled entirely from a surgeon’s console using a robotic
grasper which allows a surgeon the ability to access and visualize
a wide variety of surgical planes.
“This new Precise Flex version of J-Plasma® offers surgeons the
ability to use J-Plasma® in areas of the anatomy that otherwise
couldn’t be reached with the laparoscopic version,” said Vipul
Patel, M.D., Medical Director of Global Robotics Institute at
Florida Hospital Celebration Health. “Combining this flexibility
with the Cool-Coag™ technology may also allow the surgeon to
complete all aspects of cutting, coagulating and ablating tissue
with one instrument potentially reducing the need to use other
instruments.”
“The clearance of the J-Plasma® Precise Flex is an important
milestone for our company as part of our strategy to increase
utilization of our innovative technologies in robotic surgery,”
said Robert L. Gershon, Chief Executive Officer. “This clearance
comes on the heels of the recently announced 510k clearances of
both our Cool-Coag™ generator and our new open handpiece; together,
the J-Plasma® Precise Flex handpiece and Cool-Coag™ technology
allows surgeons to benefit from using a single device that offers
greater control of tissue effect while being able to switch to a
monopolar or helium spray coagulation mode from the robotic
console. We look forward to a commercial launch of this innovative
technology for use in both open and minimally invasive surgical
procedures, including laparoscopic and robotic approaches in the
second half of 2017.”
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 website www.boviemed.com.
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version on businesswire.com: http://www.businesswire.com/news/home/20170508005374/en/
Investors:Westwicke Partners on behalf of Bovie Medical
CorporationMike Piccinino, CFA,
443-213-0500investor.relations@boviemed.com
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