Healthcare Industry News:  vascular access 

Devices Surgery Oncology

 News Release - July 2, 2012

Journal of the American College of Surgeons Publishes Study on Using the NanoKnife(R) System to Treat Liver Tumors Adjacent to Blood Vessels

ALBANY, N.Y., July 2, 2012 -- (Healthcare Sales & Marketing Network) -- AngioDynamics (ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced the publication of a study in the Journal of the American College of Surgeons, titled, "Ablation of Perivascular Hepatic Malignant Tumors with Irreversible Electroporation." The study's authors -- all physicians at Memorial Sloan Kettering Cancer Center -- included Doctors Peter Kingham, Yuman Fong, Ami Karkar, Michael D'Angelica, Peter Allen, Ronald DeMatteo, George Getrajdman, Constantinos Sofocleous, Stephen Solomon, and William Jarnagin.

The study is a retrospective review of patients treated with the NanoKnife(R) System between January 1 and November 2, 2011. Twenty-eight patients had 65 tumors treated that were near blood vessels. Median tumor size was 1 cm.

Post-operative imaging was used to assess the state of blood vessels adjacent to tumors treated with the NanoKnife System. All blood vessels were judged healthy. A single post-procedure vessel occlusion occurred in one of the tumors. This patient had a history of metastatic colorectal cancer and multiple liver resections previously.

At an average follow-up of six months, 96% of patients were without persistent disease and 95% of tumors had not recurred locally.

Before having a procedure, all patients had locally advanced pain with a median pain score of five on a scale of three to nine and were taking a median dose of 75 mcg of a narcotic per day. At 90-days follow-up the average narcotic use was 25 mcg per day, with an average pain score of three. Complications included one intra-operative arrhythmia and one post-operative portal vein thrombosis. Overall morbidity was 3%. There were no treatment-associated mortalities.

The authors concluded that their early analysis of the NanoKnife(R) System demonstrated safety for treating liver malignancies adjacent to blood vessels, potentially expanding therapeutic options for physicians in previously challenging areas. They further concluded that larger studies and longer follow-ups are necessary to determine long-term efficacy.

Another study regarding the NanoKnife System was published in the journal, titled, "Irreversible Electroporation Therapy in the Management of Locally Advanced Pancreatic Adenocarcinoma." The authors include Doctors Robert Martin and Susan Ellis at the University of Louisville School of Medicine, Louisville, Ky.; and Doctors Kelli McFarland and Vic Velanovich at Henry Ford Hospital, Detroit, Mich. The study concerned data presented at the Society of Surgical Oncology (SSO) 2012 conference that took place March 21-24, 2012, in Orlando, Fla.

In the United States, the NanoKnife System has been cleared by the FDA for use in the surgical ablation of soft tissue. The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition. Dr. Solomon is the principal investigator on research grants funded by AngioDynamics. Dr. Martin is a paid consultant for AngioDynamics. Partial support of the Soft Tissue Ablation Registry has come from grants funded by AngioDynamics.

About AngioDynamics

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, vascular access products, angiographic products and accessories, angioplasty products, drainage products, thrombolytic products and venous products. More information is available at 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, 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, 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, 2011, and AngioDynamics' Forms 10-Q for the quarterly periods ended November 30, 2011, and February 29, 2012. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.


Source: AngioDynamics

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