Last month, the company also secured CE mark approval for the device, which will enable surgeons to access and close the left-ventricle instantaneously and without suturing the myocardium.

Permaseal, which features PolyCor anchor technology, was validated in the secure transapical access and closure study (STATIS) carried out at five European sites.

According to the company, the results indicated that Permaseal decreased operating time and hospital stay, as well as reduced adverse events such as the need for transfusion.

The technology is said to provide access and closure site for emerging complex structural heart disease procedures such as TAVR, TMVR, PFO, and other minimally invasive cardiac procedures.

MID president and CEO Michael Whitman said: “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.”

Permaseal is claimed to be the only transapical access and closure device available for commercial use in the US and EU.

MID is engaged in the development and manufacturing of minimally invasive and catheter-based technologies, which can be used in cardiac surgery and interventional cardiology.

Image: Permaseal transapical access and closure device. Photo: courtesy of PRNewsFoto / Micro Interventional Devices, Inc.