FlowCardia's VP wire and sheath:
This article was originally published in Clinica
Representing its US market debut, FlowCardia has received US FDA 510(k) clearance for its VP wire and VP sheath products for facilitating the introduction and navigation of balloon catheters and other interventional devices in angioplasty procedures. The Sunnyvale, California firm also said that it was making progress in a US trial of its Crosser device for recanalising vessels with a chronic total occlusion (CTO). Over 80 of the required 125 patients have been enrolled in the pivotal phase of the study, called FACTOR. FlowCardia said it hoped to obtain FDA clearance for the product before the end of 2006.