Pivotal Milestone Accelerates Pathway to
Specific Indication
AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative
medical technology company focused on restoring healthy blood flow
in the body’s vascular system, expanding cancer treatment options
and improving quality of life for patients, today announced that
the U.S. Food and Drug Administration (FDA) has granted
Breakthrough Device designation for the Company’s AngioVac System
for the proposed indications for use to include the non-surgical
removal of vegetation from the right heart.
The FDA Breakthrough Device designation is designed to help
patients gain timely access to medical devices that may provide
more effective treatment or diagnosis of life-threatening or
irreversibly debilitating diseases or conditions for which no
approved or cleared alternatives exist.
“The FDA’s recognition of the AngioVac System and its potential
to provide a novel and innovative treatment pathway for the
non-surgical removal of vegetation from the right heart represents
a significant step in our journey to advance patient care,” said
Jim Clemmer, AngioDynamics’ President and Chief Executive Officer.
“The support of our physician partners continues to lead us in the
development, study and application of this innovative technology to
treat and manage critical medical conditions for a patient
population with an unmet need.”
The AngioVac System is an on-circuit aspiration system that uses
a venous drainage cannula to remove thrombi or emboli during
extracorporeal bypass for up to six hours. The system allows for
the removal of thrombus and embolic material while minimizing blood
loss via a recirculation of blood through the AngioVac
extracorporeal (venovenous) bypass circuit. Target vessels for the
thrombus/embolus extraction include, but are not limited to, the
iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava
(SVC) and Right Heart.
Under the Breakthrough Device designation, AngioDynamics will
engage with the FDA to achieve this new expanded indication for the
non-surgical removal of vegetation from the right heart. The
accelerated pathway expedites assessment and review processes of
the AngioVac System and allows for more interactive and timely
communication with the FDA, efficient and flexible clinical study
design, FDA review team support, Agency senior management
engagement and priority review.
Learn more about the AngioVac System at AngioVac.com.
About AngioDynamics, Inc.
AngioDynamics is a leading and transformative medical technology
company focused on restoring healthy blood flow in the body’s
vascular system, expanding cancer treatment options and improving
quality of life for patients.
The Company’s innovative technologies and devices are chosen by
talented physicians in fast-growing healthcare markets to treat
unmet patient needs. For more information, visit
www.angiodynamics.com.
*Indications for Use: The AngioVac C20 and C180 is indicated for
use as a venous drainage cannula and for removal of fresh, soft
thrombi or emboli during extracorporeal bypass for up to 6 hours.
The AngioVac F1885 is indicated as a venous drainage cannula for
the non-surgical removal of thrombi or emboli during extracorporeal
bypass for up to 6 hours.
The AngioVac Circuit is indicated for use in procedures
requiring extracorporeal circulatory support for periods of up to
six hours.
CAUTION: Federal law (USA) restricts this device to sale by or
on the order of a physician.
For important AngioVac Cannula and Circuit risk information,
visit:
AngioVac Cannula C20 and C180
https://www.angiodynamics.com/about-us/risk-information/#bangiovaccann
AngioVac Cannula F1885
https://www.angiodynamics.com/about-us/risk-information/#cangiovaccann1885
AngioVac Circuit
https://www.angiodynamics.com/about-us/risk-information/#cangiovac
Safe Harbor
This 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 the words such as “expects,” “reaffirms,” “intends,”
“anticipates,” “plans,” “believes,” “seeks,” “estimates,”
“projects”, “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 materially from AngioDynamics’
expectations, expressed or implied. Factors that may affect the
actual results achieved by AngioDynamics include, without
limitation, the scale and scope of the COVID-19 global pandemic,
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 (including inflation, labor shortages and
supply chain challenges including the cost and availability of raw
materials), 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
obtain regulatory clearances or approval of its products, or to
integrate acquired 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, 2023. AngioDynamics does not assume any obligation to publicly
update or revise any forward-looking statements for any reason.
AngioDynamics, the AngioDynamics logo and AngioVac are
trademarks and/or registered trademarks of AngioDynamics, Inc., an
affiliate or subsidiary. All other trademarks are property of their
respective owners.
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version on businesswire.com: https://www.businesswire.com/news/home/20230815110351/en/
Investor Relations: Stephen Trowbridge 518-795-1408
strowbridge@angiodynamics.com
Media: Saleem Cheeks 518-795-1174
scheeks@angiodynamics.com
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