Possis Medical answers FDA questions
This article was originally published in Clinica
Executive Summary
Possis Medical says it has submitted supplementary data on its AngioJet thrombectomy catheter to the US FDA. Possis submitted a 510(k) for peripheral artery applications in March, but only used data from the first 86 patients out of a full cohort of 130. However, the FDA insisted that it should receive either the full data set or proof that 86 patients were sufficient to demonstrate the safety of AngioJet (see Clinica No 712, p 19). Possis spokesman Robert Dutcher says the company now has clinical data (which compares AngioJet to the Fogarty embolectomy catheter) for all 130 patients and has submitted it to the agency.