Micro Interventional Devices, Inc. (MID) has 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 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 percent. 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.
“The FDA market clearance of Permaseal is another tremendous achievement for MID,” said Michael Whitman, MID’s President & CEO. “This exciting development comes fast on the heels of our recent European approval. With the US approval, coming earlier than expected, MID will be initiating its US commercialization ahead of schedule. We are excited that this technology is now available to our US and European surgeons and their patients.”
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.