AngioDynamics Receives Expanded "No Chest X-Ray" FDA Clearance for Celerity Tip Location System


ALBANY, N.Y., Jan. 29, 2015 (GLOBE NEWSWIRE) -- AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced the U.S. Food and Drug Administration (FDA) cleared an expanded indication for the Celerity tip location system.

The new clearance allows for the elimination of a follow-up X-ray when the Celerity system is used to aid in positioning Peripherally Inserted Central Catheters (PICCs) in adults. The system works by utilizing the patient's cardiac electrical activity to provide real time catheter tip location, offering accuracy on par with similar devices currently marketed, at or above 97% as compared to chest X-ray.1

"I am very pleased we achieved this essential milestone for our Vascular Access business" said Joseph M. DeVivo, AngioDynamics' President and Chief Executive Officer. "This new indication will provide more efficient use for patients and clinicians, and unlock the potential of BioFlo PICCs for customers who rely on a tip location device exclusively."

According to recent early data collected by Nurse Pro Plus, a third-party PICC placement contractor used by hospital systems throughout the U.S., the Celerity system is showing extremely favorable results for both patients and hospitals.

"Since we started using the Celerity tip location system, we have been seeing very successful results with our patients," said Nurse Pro Plus Owner Dan Estel. "As a service provider, we know that price plays a big factor, and the Celerity system matches well with BioFlo PICCs, which themselves are providing a favorable economic model for our business and the hospitals we serve. With our BioFlo PICC placements, we have seen decreased Alteplase use, as well as a reduction in DVTs."

"The cost savings associated with using the Celerity system to aid in PICC placements has created a strong demand from our clients," added Chuck Greiner, Senior Vice President of AngioDynamics' Vascular Access Business. "This expanded indication promises to reduce supply and labor cost for our customers, as well as optimize patient care by decreasing delays in treatment. Coupled with its ease of use with our thromboresistant BioFlo PICCs, the Celerity system will improve patient outcomes while reducing healthcare costs to many more hospitals and patients across the U.S."

                                             
1 Celerity Beta Site Experience, Nurse Pro Plus AVA Presentation on initial Celerity Experience, Sept. 3, 2014.

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, 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.

Trademarks

AngioDynamics, the AngioDynamics logo and BioFlo are trademarks and/or registered trademarks of AngioDynamics Inc., an affiliate or a subsidiary. Celerity is trademarks and/or registered trademarks of Medical Components Inc.

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, 2014, its Annual Report on Form 10-K/A for the fiscal year ended May 31, 2014, and its quarterly report on form 10-Q for the fiscal quarter ended August 31, 2014, and the current reports on Form 8-K, filed with the SEC on October 9, 2014, Oct. 31, 2014, and November 14, 2014. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.



            

Tags


Contact Data