Orthovita's Cellpaker plasma collector
This article was originally published in Clinica
Executive Summary
The US FDA has sanctioned Orthovita's premarket approval (PMA) supplement to sell Cellpaker plasma collection systems that are manufactured at its subcontractor's facility. The system is used with the firm's surgical haemostat Vitagel. Cellpaker collects the patient's own plasma, which is then mixed with the haemostat before use in surgery. Malvern, Pennsylvania-based Orthovita has been distributing Vitagel and Cellpaker since January 2005 under a deal with Angiotech BioMaterials. Pursuant to a March 2006 licence pact with its partner's affiliate, Angiotech Pharmaceuticals, manufacturing obligations for both products shifted to Orthovita. Orthovita started manufacturing Vitagel in July 2006 and said it would immediately start sales of Cellpaker manufactured on its behalf.