Micro Interventional Devices has received FDA market clearance for its Permaseal transapical access and closure device—just seven weeks after the device was CE mark approved. The Permaseal device allows surgeons to access and close the left-ventricle instantaneously, reliably and without suturing the myocardium. It is the world’s first device using compliant soft-tissue PolyCor anchor technology.
A press release reports that 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 transcatheter aortic valve implantation and other minimally invasive cardiac procedures.
Michael Whitman, president and chief executive officer of Micro Interventional Devices, comments: “The FDA market clearance of Permaseal is another tremendous achievement for Micro Interventional Devices. This exciting development comes fast on the heels of our recent European approval. Sales in Europe are exceeding our early expectations. With the US approval, coming earlier than expected, Micro Interventional Devices will be initiating its US commercialisation ahead of schedule.”
Permaseal is currently the only transapical access and closure device available for commercial use in the USA. Permaseal is also available in the EU.