MID's Permaseal transapical access and closure device receives FDA Market clearance

Micro Interventional Devices, Inc.™ (MID), the world leader in minimally invasive and catheter-based compliant fixation technologies addressing structural heart disease announced today that it received FDA Market clearance for the Company's first product: Permaseal™ transapical access and closure device. This comes just seven weeks after the CE Mark approval. The Permaseal device allows surgeons to access and close the left-ventricle instantaneously, reliably and without suturing the myocardium. Permaseal is the world's first device using compliant soft-tissue PolyCor^TM anchor technology.

Permaseal was validated in the STASIS Clinical Study (Secure Transapical Access and Closure 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%. The technology provides a direct, safe and simple, access and closure site for emerging complex structural heart disease procedures including TAVR, TMVR, PFO, and other minimally invasive cardiac procedures.

Permaseal is currently the only transapical access and closure device available for commercial use in the United States. Permaseal is also available in the EU.