Micro Interventional Devices (MID) has secured CE mark approval for its Permaseal transapical access and closure device.
The Permaseal device has been developed for surgeons to access and close the left-ventricle instantaneously and without suturing the myocardium.
Featuring soft-tissue PolyCor anchor technology, the Permaseal was validated in the secure transapical access and closure study (STATIS) conducted at five European sites.
The technology offers access and closure site for emerging complex structural heart disease procedures such as TAVR, TMVR, PFO, as well as other minimally invasive cardiac procedures.
According to the company, Permaseal is currently the only transapical access and closure device available for commercial use in the EU.
The device yet to receive approval from the US Food and Drug Administration.
MID founder and CEO Michael Whitmam said: "The CE Mark approval of Permaseal is a tremendous achievement for MID.
"Permaseal is the first in a series of products designed to replace the need for suturing in structural heart procedures.
"In the near future, PolyCor and MyoLast 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."
Image: Permaseal transapical access and closure device. Photo: courtesy of PRNewsFoto / Micro Interventional Devices, Inc.