FDA clears Spire's "innovative" catheter insertion kit:
This article was originally published in Clinica
Executive Summary
Spire Biomedical has received US FDA 510(k) clearance to market a kit that it claims provides an innovative method for inserting the company's haemodialysis catheters - Pourchez XpressO and Pourchez RetrO. The SafeTrac dual wire insertion kit, which uses an over-the-wire insertion method, eliminates potential complications associated with the traditional method for inserting tunnelled haemodialysis catheters, says the Bedford, Massachusetts firm. The conventional insertion method, the firm notes, involves using a sheath/dilator to help guide the catheter into the vascular system.