Second paragraph, first sentence of release should read: The
additional indications clear the OARtrac System for use with
patient-specific, pre-calibrated Plastic Scintillating Detector
(PSD) sensors used during cancer treatments to measure photon and
electron radiation therapy as an adjunct to treatment
planning (instead of: The additional indications clear the
OARtrac System for use with patient-specific, pre-calibrated peak
skin dose (PSD) sensors used during cancer treatments to measure
photon and electron radiation therapy as an adjunct to treatment
planning).
The corrected release reads:
OARtrac® RADIATION DOSE
MONITORING SYSTEM RECEIVES EXPANDED FDA CLEARANCE FOR ELECTRON
RADIATION THERAPY
AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of
innovative, minimally invasive medical devices for vascular access,
peripheral vascular disease and oncology, today announced that the
United States Food and Drug Administration (FDA) granted an
expanded 510(k) clearance for the OARtrac Radiation Dose Monitoring
System.
The additional indications clear the OARtrac System for use with
patient-specific, pre-calibrated Plastic Scintillating Detector
(PSD) sensors used during cancer treatments to measure photon and
electron radiation therapy as an adjunct to treatment planning. The
OARtrac System allows clinicians to measure and validate radiation
doses targeted to a specific area of a patient’s body, allowing for
more accurate and informed dosing.
The OARtrac System was previously cleared for use in the
real-time monitoring and measurement of photon radiation and high
dose rate (HDR) brachytherapy during cancer treatments on both the
skin surface and with endorectal balloon (ERB) applications. The
expanded Indication for Use now provides radiation oncologists and
medical physicists with a tool to monitor and measure radiation
doses in patients who receive electron radiation therapy, one of
the most common radiotherapy treatments.
The system is also indicated for use with photon and electron
energy when adhered to the skin or inserted into the rectum,
allowing physicians to utilize a specifically designed OARtrac
endorectal balloon device to take measurements at the rectal wall
during cancer treatment.
“This expanded clearance provides us the opportunity to address
an unmet need for patients in three of the most common types of
radiation therapy, allowing for significantly improved outcomes,”
said Brent Boucher, Senior Vice President for Oncology at
AngioDynamics. “OARtrac is the type of disruptive technology that
our customers value, and our team will continue to focus on
creating additional pathways to help clinicians deliver the best
possible treatment for their patients.”
AngioDynamics added the OARtrac System to its growing Oncology
portfolio in 2018 when it acquired RadiaDyne and its market-leading
balloon stabilizing technologies. The OARtrac System is a
first-of-its-kind, patented, radiation dose monitoring technology
that provides precise, real-time measurement via a proprietary
intracavitary device. The system delivers critical dose feedback to
medical and radiation oncologists, providing customized adaptive
radiotherapy, reduced side effects, and improved clinical outcomes
across the three most common types of radiation therapy: photon,
electron, and HDR brachytherapy.
About AngioDynamics, Inc.
AngioDynamics, Inc. is a leading provider of innovative,
minimally invasive medical devices used by professional healthcare
providers for vascular access, 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. For more information,
visit www.angiodynamics.com.
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,"
"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 fourth 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
fourth-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 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,
2018. AngioDynamics does not assume any obligation to
publicly update or revise any forward-looking statements for any
reason.
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version on businesswire.com: https://www.businesswire.com/news/home/20190328005660/en/
Investor Relations Contact:AngioDynamics, Inc.Michael
Greiner518-795-1821mgreiner@angiodynamics.com
Media Contact:AngioDynamics, Inc.Saleem
Cheeks518-795-1174scheeks@angiodynamics.com
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