Advertisement
Advertisement
February 8, 2010
CENTRAL Study of FlowCardia’s Crosser Initiated
February 9, 2010—FlowCardia, Inc. (Sunnyvale, CA) announced the initiation of enrollment for the CENTRAL (Crosser Enters the Right Arterial Lumen) study of the company's Crosser recanalization catheter for treating chronic total occlusions (CTOs). The Crosser uses a high-frequency mechanical vibration to pass through the blockage in the central lumen of the artery.
The eight-hospital, 100-patient CENTRAL study is designed as a single-arm registry that involves recanalizing the occlusion and demonstrating successful navigation of the Crosser catheter in the central lumen of the artery, as confirmed by intravascular ultrasound. The study will also measure the re-entry ratio or utilization rate of lumen re-entry devices during CTO recanalization procedures. When CTOs are crossed within the central lumen of the artery, the need for these re-entry devices is dramatically reduced, the company noted. Tom Davis, MD, is the national principal investigator of the CENTRAL study.
Advertisement
Advertisement
