AngioDynamics Receives Expanded "No Chest X-Ray" FDA Clearance for Celerity Tip Location System
Sunday, February 1, 2015
Source: Angio Dynamics
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."