AngioDynamics has announced the U.S. Food and Drug Administration (FDA) rejected its distribution partner, Medcomp's 510(k) application for the Celerity tip location system.
AngioDynamics has determined the Agency’s decision resulted from the execution of a human factors study rather than the device itself.
Following discussions with the Agency, AngioDynamics believes it can fully address these issues in a subsequent filing, which it expects to be submitted in early April.
As a result of these developments, AngioDynamics executed an agreement with Medcomp and Medcomp’s development partner to acquire regulatory control over the Celerity platform and exclusive rights to a next generation system that includes navigation capabilities.
AngioDynamics president and chief executive officer Joseph M DeVivo said based on company’s review and discussions with the Agency, it has established a clear regulatory path to bring Celerity to the US market by mid-summer.
"With this new agreement, we have established a clear plan to build a strong tip-location portfolio that includes next-generation product introductions.
"Our Vascular Access Business has been strengthening over the last several quarters with building clinical evidence of our BioFlo thrombus-resistant catheters," DeVivo added.
AngioDynamics continues to sell Celerity in Canada, where the market response to the combined offering of the system with the Company’s thromboresistant BioFlo PICC has been positive.