Bovie Medical Receives FDA 510(k) Clearance for Its ‘PlazXact™’ Ablator
August 16 2016 - 8:00AM
Business Wire
– New bipolar ablator offers precision and
safety for arthroscopic procedures using lower power settings –
– Compatible with standard electrosurgical
generators –
– Aligned with Bovie’s strategy to develop
advanced energy products through focused R&D activities –
Bovie Medical Corporation (NYSEMKT: BVX), a maker of
medical devices and supplies and the developer of J-Plasma®, a
patented new surgical product, announced today that it has received
510(k) clearance from the Food and Drug Administration for its new
bipolar ablator, branded ‘PlazXact™’, an innovative tool
that offers surgeons precision and safety when performing
arthroscopic procedures.
The PlazXact™ received clearance for the cutting,
vaporization and coagulation of soft tissue during arthroscopic
surgical procedures, and will operate with a standard saline
irrigation solution. The device’s efficient tip design results in
lower saline temperatures, and it has the advantage of being
compatible with standard electrosurgical generators found in
ambulatory surgical centers and hospital operating rooms.
“This new product launch demonstrates our R&D capabilities
around advanced energy products, and PlazXact™, like other
Bovie products, features a high level of precision combined with
the additional safety of lower power requirements,” said Robert L.
Gershon, Chief Executive Officer. “We see an important market
opportunity among orthopedic surgeons treating sports injuries and
age-related joint damage, and we are confident that the
PlazXact™ has the potential to become an important tool in a
broad range of arthroscopic procedures. Currently, we are
evaluating options for full commercialization of the product,
including the potential for sales channel partnerships.”
“Over the course of the last two years, we have invested in
further developing Bovie’s R&D capabilities to take advantage
of opportunities within our existing product portfolio as well as
to leverage our deep domain experience in the manufacture of
advanced energy products. The PlazXact™ is our first entry
into the arthroscopic surgery market, and we expect to launch
additional growth products in 2017 and beyond,” Mr. Gershon
concluded.
The PlazXact™ will be available with shaft diameters of
3.3mm, 2.4mm and 1.8mm, which will operate with electrode face
angles of 90°, 50° and 60° respectively. The 3.3mm models will be
available in both aspirating and non-aspirating versions, while all
others will be available as non-aspirating versions only. For
further information on the product, please visit the Bovie Medical
website at www.boviemed.com.
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.
Cautionary Statement on Forward-Looking Statements
Certain matters discussed in this release and oral statements
made from time to time by representatives of the Company may
constitute forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 and the Federal
securities laws. Although the Company believes that the
expectations reflected in such forward-looking statements are based
upon reasonable assumptions, it can give no assurance that its
expectations will be achieved.
Forward-looking information is subject to certain risks, trends
and uncertainties that could cause actual results to differ
materially from those projected. Many of these factors are beyond
the Company’s ability to control or predict. Important factors that
may cause actual results to differ materially and that could impact
the Company and the statements contained in this release can be
found in the Company’s filing with the Securities and Exchange
Commission including the Company’s Report on Form 10-K for the year
ended December 31, 2015 and subsequent 10-Q filings. For
forward-looking statements in this release, the Company claims the
protection of the safe harbor for forward-looking statements
contained in the Private Securities Litigation Reform Act of 1995.
The Company assumes no obligation to update or supplement any
forward-looking statements whether as a result of new information,
future events or otherwise.
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version on businesswire.com: http://www.businesswire.com/news/home/20160816005098/en/
Investor Relations:MBS Value PartnersHugh Collins,
212-223-4632investor.relations@boviemed.com
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