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FlowCardia Begins Enrollment In CENTRAL Study

FlowCardia, a developer of endovascular devices for the treatment of chronic total occlusions (CTOs), has reported that the Christ Hospital in Cincinnati, Ohio, has enrolled the first patient in its CENTRAL (Crosser ENters The Right Arterial Lumen) study.

The CENTRAL study is designed as a single arm registry that involves recanalizing the occlusion and demonstrating navigation of the Crosser Catheter in the central lumen of the artery, as confirmed by Intravascular Ultrasound (IVUS).

The Crosser CTO Recanalization Catheter is a minimally-invasive endovascular device that is delivered to the blockage within the artery using standard guidewire techniques. The doctor then activates the Crosser Catheter which utilises high-frequency, mechanical vibration to pass through the blockage in the central lumen of the artery. Once the Crosser Catheter passes through the occlusion, physicians can then perform standard procedures to optimize the longer term outcomes.

Tom Davis, national principal investigator of the CENTRAL study at St John Hospital and Medical Center in Detroit, Michigan, said: “This study will validate the Crosser Catheter’s ability to provide treatment while staying within the central lumen of the artery to a greater degree than the currently available recanalization devices and techniques.”

John Paul Runyon, an interventional cardiologist at the Christ Hospital in Cincinnati, Ohio, said: “The acute benefits of staying within the central lumen and not causing trauma to the artery wall are well documented and we are excited to be involved in this study. Most treatment options for peripheral artery disease require staying in the central lumen to be most effective. Using the Crosser Catheter as a front line therapy allows us to use further treatment options resulting in increased long term benefits to the patient.”