AngioDynamics Announces FDA Clearance for The Solero Microwave Tissue Ablation System
June 07 2017 - 6:00AM
AngioDynamics (Nasdaq:ANGO), a leading provider of innovative,
minimally invasive medical devices for vascular access, peripheral
vascular disease and oncology/surgery, today announced the U.S.
Food and Drug Administration (FDA) has granted 510(k) clearance for
the Solero Microwave Tissue Ablation (MTA) System. The Solero MTA
System and Accessories are indicated for the ablation of soft
tissue during open procedures. The Solero MTA System is not
intended for cardiac use.
“The U.S. market has been asking AngioDynamics for a solid
state, simple, fast, portable and scalable single applicator
microwave system,” said Rick Stark, Senior Vice President and
General Manager of the Oncology/Surgery division of AngioDynamics.
“The launch of the Solero in the U.S. will fulfill our commitment
to physicians and provide them the innovative tools they have been
asking for in the ablation of soft tissue.”
The Solero MTA System features the Solero Microwave (MW)
Generator and the specially designed Solero MW Applicators. The
solid state Solero MW Generator with a 2.45 GHz operating frequency
can power up to 140 W for optimized power delivery and fast
ablations. The Solero MW Applicator’s optimized ceramic tip
diffuses MW energy nearly spherically, and its patented cooling
channel with thermocouple provides real-time monitoring to help
protect non-targeted tissue ablation. In addition, the Solero MTA
System offers physicians scalability with a single applicator
designed for multiple, predictable ablation volumes by varying time
and wattage.
About AngioDynamicsAngioDynamics Inc. is a
leading provider of innovative, minimally invasive medical devices
used by professional healthcare providers for vascular access,
surgery, peripheral vascular disease, and
oncology. AngioDynamics' diverse product lines include
market-leading ablation systems, fluid management systems, vascular
access products, angiographic products and accessories, drainage
products, thrombolytic products and venous products. More
information is available at www.AngioDynamics.com.
TrademarksAngioDynamics, the AngioDynamics logo
and Solero are trademarks and/or registered trademarks of
AngioDynamics Inc., an affiliate or a subsidiary.
Safe HarborThis release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements
regarding AngioDynamics' expected future financial
position, results of operations, cash flows, business strategy,
budgets, projected costs, capital expenditures, products,
competitive positions, growth opportunities, plans and objectives
of management for future operations, as well as statements that
include words such as "expects," "reaffirms," "intends,"
"anticipates," "plans," "believes," "seeks," "estimates,"
"optimistic," or variations of such words and similar expressions,
are forward-looking statements. These forward-looking statements
are not guarantees of future performance and are subject to risks
and uncertainties. Investors are cautioned that actual events or
results may differ from AngioDynamics' expectations.
Factors that may affect the actual results achieved
by AngioDynamics include, without limitation, the ability
of AngioDynamics to develop its existing and new
products, technological advances and patents attained by
competitors, infringement of AngioDynamics' technology or
assertions that AngioDynamics' technology infringes the
technology of third parties, the ability
of AngioDynamics to effectively compete against
competitors that have substantially greater resources, future
actions by the FDA or other regulatory agencies, domestic
and foreign health care reforms and government regulations, results
of pending or future clinical trials, overall economic conditions,
the results of on-going litigation, challenges with respect to
third-party distributors or joint venture partners or
collaborators, the results of sales efforts, the effects of product
recalls and product liability claims, changes in key personnel, the
ability of AngioDynamics to execute on strategic
initiatives, the effects of economic, credit and capital market
conditions, general market conditions, market acceptance, foreign
currency exchange rate fluctuations, the effects on pricing from
group purchasing organizations and competition, the ability
of AngioDynamics to integrate purchased businesses, as
well as the risk factors listed from time to time
in AngioDynamics' SEC filings, including but not
limited to its Annual Report on Form 10-K for the year
ended May 31, 2016 and its quarterly report on Form 10-Q
for the fiscal periods ended August 31, 2016, November
30, 2016 and February 28, 2017. AngioDynamics does not
assume any obligation to publicly update or revise any
forward-looking statements for any reason.
Contact Information:
Caitlin Stefanik
518-795-1418
cstefanik@angiodynamics.com
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