FDA asks Possis for AngioJet trial details:
This article was originally published in Clinica
Executive Summary
The FDA has asked Possis Medical to supply more details on the statistical methods used in the clinical trials of its AngioJet Rapid Thrombectomy System. The system was submitted for a 510(k) clearance in July and is designed to removed blood clots from vessels throughout the body. Possis is expecting to provide this extra information by mid-November and hopes the FDA will respond within 90 days of its submission.