AngioDynamics (NSDQ:ANGO) said today that it won approval from Health Canada for its Celerity with Navigation tip location system for peripherally inserted central catheters.
Latham, N.Y.-based AngioDynamics won approval north of the border for the 1st Celerity iteration back in September 2013.
The new version is designed to allow real-time catheter tracking, the company said.
“This is an important milestone as it is the first clearance for Celerity with Navigation,” president & CEO Joseph DeVivo said in prepared remarks. “We have a very strong PICC business in Canada and we are pleased to bring this technology to PICC teams throughout the country. Also, we filed for U.S. FDA 510(k) clearance in November, and are hoping to receive that approval before the end of our fiscal year.”
The fiscal year ends in November for AngioDynamics.
“The approval of Celerity with Navigation by Health Canada is a tremendous opportunity for the AngioDynamics sales team, our customers and patients,” added vascular access SVP Chuck Greiner. “This technology allows more clinicians and patients to experience the clinical benefits of BioFlo. Many of our customers are dependent upon Navigation for PICC placement, but have a desire to use BioFlo. The launch of Celerity with Navigation will allow those customers to access the anti-thrombogenic benefits that BioFlo offers along with the increased ease-of-use that the technology offers. We are now better positioned than ever to compete in the global PICC market.”