ALBANY, N.Y., Aug. 13, 2015 (GLOBE NEWSWIRE) -- AngioDynamics (NASDAQ:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced today the publication of clinical data from STAR (Soft Tissue Ablation Registry) utilizing NanoKnife®, in the Annals of Surgery.
The published paper entitled: Treatment of 200 Locally Advanced (Stage III) Pancreatic Adenocarcinoma Patients With Irreversible Electroporation, Safety and Efficacy appears in the September 2015 online edition of the peer-reviewed journal. STAR was first presented at the American Surgical Association annual meeting in San Diego earlier this year as an analysis of Irreversible Electroporation (IRE) performed on 200 consecutive patients diagnosed with locally advanced pancreatic cancer (LAPC).
The authors of the paper, led by Robert Martin, M.D., Ph.D., F.A.C.S., director of the Division of Surgical Oncology, and Professor, Department of Surgery, University of Louisville, James Graham Brown Cancer Center, stated in the paper's conclusion that they believe, "IRE results in substantially prolonged survival of patients with LAPC compared with historical controls."
The paper states that the goal of the study was to evaluate the effectiveness of IRE as a consolidative therapy in combination with chemotherapy and/or chemoradiation therapy in the management of LAPC.
Pancreatic cancer has one of the highest mortality rates of all cancers and is expected to climb from the fourth leading cause of cancer-related death in the U.S. to the second by 2020. Ninety-four percent of pancreatic cancer patients will die within five years of diagnosis, and 74 percent of patients die within the first year of diagnosis.
The study was partially funded by a grant provided by AngioDynamics.
From July 2010 to October 2014, patients with radiographic stage III LAPC were treated with IRE and monitored under a multicenter, prospective institutional review board-approved registry. STAR recorded perioperative 90-day outcomes, local failure, and overall survival in six centers in the U.S. The centers that collaborated on the study included University of Louisville, Louisville, Ky.; Henry Ford Hospital, Detroit, Mich.; Cleveland Clinic, Cleveland, Ohio; Piedmont Hospital, Atlanta, Ga.; Swedish Medical Center, Denver, Colo.; and Cancer Treatment Centers of America, Atlanta, Ga.
A total of 200 patients with LAPC underwent IRE alone (n = 150) or pancreatic resection plus IRE for margin enhancements (n = 50). All patients underwent induction chemotherapy with 52 percent receiving chemo-radiation, for a median of seven months (range, 5-13) prior to IRE. IRE was successfully administered to all patients. Thirty-seven percent of patients sustained complications with a median grade of 2 (range 1-5). Median length of stay was six days (range, 4-36 days) with a median follow-up of 29 months. Six patients (3%) experienced local recurrence. Median overall survival in both groups was 24.9 months (range: 4.9 – 85 months).
The NanoKnife® System is designed for the ablation of soft tissue and is the first ablation system to use a series of high-voltage, but low-energy electrical pulses which are believed to permanently open pores in cell membranes. The NanoKnife® system is approved by the U.S. Food and Drug Administration for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.
AngioDynamics 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, angioplasty products, drainage products, thrombolytic products and venous products. More information is available at www.AngioDynamics.com.
AngioDynamics, the AngioDynamics logo, and NanoKnife, are trademarks and/or registered trademarks of AngioDynamics Inc., an affiliate or a subsidiary.
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, 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, 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, including Navilyst Medical and its products, R&D capabilities, infrastructure and employees 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, 2015. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
In the United States, the NanoKnife System has received a 510(k) clearance by the Food and Drug Administration for use in the surgical ablation of soft tissue, and is similarly approved for commercialization in Canada, the European Union and Australia. In the United States, the NanoKnife System has not received clearance for the therapy or treatment of any specific disease or condition.
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