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 PolyCorTM 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.
"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. Sales in Europe are exceeding our early expectations. With the US approval, coming earlier than expected, MID will be initiating its US commercialization ahead of schedule. As I recently commented, Permaseal is the first in a series of products designed to replace the need for suturing in structural heart procedures. We are excited that this technology is now available to our US and European surgeons and their patients. In the near future, PolyCor and MyoLastTM technologies will be utilized in a broad range of proprietary, catheter-based products addressing unmet needs in tricuspid repair, mitral repair and mitral valve fixation. MID's technology platform enables open-surgical procedures to be performed percutaneously."
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.
Source : finance.yahoo.com