AngioDynamics (ANGO) Granted 510(k) Clearance From FDA for Xcela Plus Port Family
6/27/2013 7:28:24 AM
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AngioDynamics Announces FDA Clearance for Xcela Plus Port Family With PASV Technology
ALBANY, N.Y., June 27, 2013 (GLOBE NEWSWIRE) -- AngioDynamics (ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced it has received two key port product clearances. The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Xcela Plus Port family, with Pressure Activated Safety Valve (PASV) technology to Navilyst Medical, an AngioDynamics company. Additionally, AngioDynamics has received the Medical Device License from Health Canada to market and sell the Smart Port CT family of power-injectable ports, featuring Vortex port technology.
The Xcela Plus Port with PASV Valve Technology is the first proximally-valved CT port in the market and is expected to be available commercially during the Company's Fiscal Year 2014 first quarter. The PASV valve technology has more than 10 years of clinical experience with ports and PICCs. In a randomized, prospective clinical study, ports with PASV valve technology were associated with significantly less nursing time and fewer instances of poor blood return as compared to non-valved ports.i The bi-directional PASV valve is designed specifically to reduce blood reflux on the inside of the catheter and may reduce the need for heparin based care and maintenance, providing less patient risk and greater economic efficiency to the hospital.
"With Xcela Plus Ports, we bolster our significant portfolio of vascular access products while meeting a large un-met need for a better valved port system," said Chuck Greiner, Vice President of AngioDynamics' Vascular Access Business. "This clearance builds on our promise to leverage differentiating technologies, and we look forward to further innovations such as the integration of our BioFlo technology into our port and dialysis product lines."
Smart Port is now officially available in Canada, and the launch supports an existing contract with HealthPRO, Canada's national healthcare group purchasing organization (GPO). HealthPRO is invested in Canada's public healthcare system by representing the purchasing interests of hospitals, provincial authorities and Shared Service Organizations (SSOs).
Vortex port technology is designed to achieve better patient outcomes, fewer complications, more efficient use of nursing time and lower expenses. The port's round chamber allows fluid to reach all surfaces in the chamber, helping eliminate dead spaces and resisting sludge build-up, while a tangential outlet creates an efficient flushing action to thoroughly cleanse the entire reservoir. The most common complications associated with the use of vascular access ports are occlusions and thrombus formations. An average 73% reduction in occlusion rates has been shown with the use of Vortex technology, compared to conventional ports.ii
Implantable ports are medical devices implanted under the skin that facilitate long-term delivery of medication and access to a patient's vascular system. The Smart Port CT family of power-injectable ports includes standard, low-profile and mini model options for repeated treatments such as chemotherapy, as well as for use with computed tomography (CT). Each model features a light-weight, titanium design and a CT-engraved port body for better identification. These ports, which also have U.S. Food and Drug Administration 510(k) clearance and are CE Marked for Europe, are clinically indicated for power-injections up to 5mL/sec and a 300 psi pressure limit setting.
"We are excited to be able to build upon our international successes with BioFlo PICC in the Canadian market with the introduction of Smart Port," said Stephen McGill, Senior Vice President and General Manager, International of AngioDynamics. "We are striving to make our technologies available to patients globally and this brings us one step closer to fulfilling that mission."
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, Navilyst, BioFlo, PASV, Smart Port, Xcela, Xcela Plus and Vortex 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, 2012. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
i Carlo JT, Lamont JP, McCarty TM, Livingston S, Kuhn JA. A Prospective Randomized Trial Demonstrating Valved Implantable Ports Have Fewer Complications and Lower Overall Cost than Non-valved Implantable Ports. Am J Surg 2004;188:722-727.
ii Stevens B, Barton SE, Brechbill M, et. al. A Randomized, Prospective Trial of Conventional Vascular Ports vs. The Vortex "Clear-Flow" Reservoir Port in Adult Oncology Patients. JVAD 2000; (Summer).
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