CORRECTING and REPLACING OARtrac® Radiation Dose Monitoring System Receives Expanded FDA Clearance for Electron Radiation Therapy
LATHAM, N.Y.--(BUSINESS WIRE)--Mar 28, 2019--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.
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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SOURCE: AngioDynamics, Inc.
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PUB: 03/28/2019 06:48 PM/DISC: 03/28/2019 06:48 PM