Micro Interventional Devices Receives FDA Clearance for Permaseal Closure Device

July 29, 2016—Micro Interventional Devices, Inc. announced that it received US Food and Drug Administration marketing clearance for the Permaseal transapical access and closure device, which is the company’s first product. The Permaseal device allows interventionists to access and close the left ventricle instantaneously without suturing the myocardium. In June, the company announced European CE Mark approval for the Permaseal.

Permaseal was validated in the STASIS clinical study 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 to 0%. 

According to the company, Permaseal uses compliant soft-tissue PolyCor anchor technology. The Permaseal device provides a direct, safe, and simple access and closure site for complex structural heart disease procedures including transcatheter aortic valve replacement, transcatheter mitral valve replacement, patent foramen ovale closure, and other minimally invasive cardiac procedures.