Micro Interventional Devices' Permaseal Receives CE Mark Approval

June 7, 2016—Micro Interventional Devices, Inc. announced it has received CE Mark approval for the company's first product, the Permaseal transapical access and closure device. The Permaseal device allows surgeons to access and close the left ventricle instantaneously, reliably, and without suturing the myocardium. Permaseal uses the company’s compliant soft-tissue PolyCor anchor technology. US Food and Drug Administration clearance to market Permaseal in the United States is pending.

According to the company, Permaseal was validated in the STASIS (Secure Transapical Access and Closure Study) clinical trial, which was conducted at five European sites. Results indicated that Permaseal shortened operating time and hospital stay, reduced adverse events, including the need for transfusion, and reduced 12-month mortality and stroke rates of 0%. The technology provides a direct, safe, and simple access and closure site for emerging complex structural heart disease procedures, including transcatheter aortic valve replacement, transcatheter mitral valve replacement, patent foramen ovale closure, and other minimally invasive cardiac procedures, advised Micro Interventional Devices, Inc.