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Medical Device Start-Up News, August 2012

Executive Summary

This month we profile CoolSpine and its catheter-based hypothermia device, Inseal Medical and its large-bore vascular closure device, and MitrAssist Medical, which is developing a valve-in-valve approach to treating mitral regurgitation.

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New Access Devices Create Gateway To Interventional Structural Heart Disease

Now that transcatheter heart valves have been implanted in thousands of humans, it’s becoming clear where the problems lie. Vascular and bleeding complications, stroke and paravalvular leaks are the most troubling consequences. Most of the focus has been on improving the valves and the delivery systems, but now innovators are looking at the issue of access – the particular ways by which therapeutic devices enter the heart – and how it can be changed to improve outcomes. In this issue we profile Apica Cardiovascular, Entourage Medical and Inseal Medical.

Apica Cardiovascular Ltd.

Apica Cardiovascular is leading the field of transapical access and closure for structural heart disease. Its first product is a titanium coil that stabilizes the surgical access site in the apex of the heart to prevent bleeding during and after therapeutic interventions and provides for reaccess in the future. Also in the works are a large closure device for transfemoral access closure and a connector that aids in the delivery and implantation of newer, smaller, left ventricular assist devices through the Apica coil.

Entourage Medical Technologies Inc.

Cardiologist and serial entrepreneur Frank Litvack, best known for founding Conor Medsystems, has picked his first opportunity in interventional structural heart disease. Litvack has co-founded Entourage Medical Technologies Inc. to develop products that support transcatheter interventions for the heart. Entourage is beginning with a transapical access and closure device with the goal of advancing transcatheter aortic valve implantation (TAVI), enabling minimally invasive mitral valve replacement and repairs, and other minimally invasive treatments for patients with structural heart disease.

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