Healthcare Industry News: vascular access
News Release - October 3, 2013
AngioDynamics Announces First Patient Enrolled in PICC Related Obstruction of Flow (PROOF) StudyMulti-Center Study Investigates Whether BioFlo PICCs Are Associated With Reduced Catheter-Related Thrombosis
ALBANY, N.Y., Oct. 3, 2013 -- (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 enrollment of the first patient at University of Miami Hospital in a randomized multi-center study investigating whether the BioFlo PICC will be associated with a reduced incidence of catheter-related venous thrombosis, including both symptomatic and asymptomatic, compared to another commercially available PICC, the Bard PowerPICC SOLO2.
BioFlo PICCs are manufactured with Endexo technology, a permanent and non-eluting integral polymer blended into the catheter shaft's polymer for long-term durability. The study, "PICC Related Obstruction of Flow" (PROOF), will enroll 354 patients at a maximum of five sites, including University of Miami Hospital, NorthShore University HealthSystem of Chicago and Ottawa Hospital Research Institute, Canada. The primary objective is to investigate the incidence of catheter-related venous thrombosis, with a secondary objective to investigate the incidence of catheter-related complications. In addition, detailed medical resource utilization data will be captured to allow for cost comparisons between the treatment groups demonstrating the likely savings to medical facilities associated with the observed reduction in thrombosis and other relevant catheter-related complications.
"Finding a solution to the risks and high cost of catheter-related thrombosis has made the long term effectiveness of a catheter a top concern for healthcare providers," Dr. David Hahn, Chief in the Section of Interventional Radiology at NorthShore University HealthSystem and lead investigator said. "I look forward to examining the BioFlo PICC and submitting data for peer review, along with reviewing other researcher's findings."
In vitro blood loop model test results show the BioFlo PICC has 87% less thrombus accumulation on its surface on average compared to commonly used PICCs based on platelet count. In addition, side-by-side in vivo test results demonstrate substantially equivalent thromboresistant characteristics as a heparin coated vascular access catheter.*
"BioFlo PICCs show promise in decreasing the accumulation of catheter-related thrombus without incorporation of antibiotics or antimicrobials, agents potentially associated with bacterial resistance, or any other transient materials typically associated with coated or impregnated technologies," said Chuck Greiner, Sr. Vice President of AngioDynamics' vascular access Business. "At AngioDynamics, we share our customers' commitment to patient safety and comfort. PROOF not only reflects our mission to provide the best products available, but proven clinical and economic data that illustrates their value."
*Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
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, BioFlo and Navilyst are trademarks and/or registered trademarks of AngioDynamics Inc., an affiliate or a subsidiary. Endexo is a registered trademark of Interface Biologics. Bard and Power PICC SOLO are trademarks and/or registered trademarks of C.R. Bard Inc.
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, 2013. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
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