In Brief: Possis Medical
This article was originally published in The Gray Sheet
Executive Summary
Possis Medical: Submission of premarket approval application expected this summer for use of the AngioJet rapid thrombectomy system to remove blood clots in coronary arteries and bypass grafts. Possis makes the prediction following a meeting with FDA in which results from a 300-patient study randomizing patients to urokinase were discussed. Per the agency's request, Possis is developing and expects to file by the end of April an investigational device exemption supplement seeking to halt blinding and randomization. The Angiojet currently is approved for treatment of dialysis access graft thrombosis...