In Brief: LocalMed
This article was originally published in The Gray Sheet
Executive Summary
LocalMed: Files investigational device exemption with FDA for its PerfusaSleeve device "which converts an ordinary angioplasty catheter into a perfusion balloon," the company says in a Feb. 8 release. Using the over-the-balloon technology employed in LocalMed's InfusaSleeve drug delivery catheter, cleared via 510(k) in October 1994 ("The Gray Sheet" Oct. 31, 1994, p. 3), PerfusaSleeve "aligns with the balloon and permits blood to flow during angioplasty procedures by routing it around the angioplasty balloon." The blood enters "perfusion channels upstream from the balloon and exits through ports distal to the balloon," LocalMed explains...