Micro Interventional Devices said today it won CE Mark approval in the European Union for its Permaseal transapical closure device.
The Permaseal closure device is designed to allow surgeons to access and close the left-ventricle instantaneously without suturing the myocardium, the Newtown, Penn.-based company 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. We are excited that this technology is now available to our European surgeons and their patients,” CEO Michael Whitman said in prepared remarks.
The newly cleared Permaseal is the 1st product from Micro Interventional Devices, and features Polycor soft-tissue anchor technology. The company touted results from a clinical study of the Permaseal device, saying the device resulted in shortened operating time, hospital stay and a reduced number of adverse events.
“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. MID’s technology platform enables open-surgical procedures to be performed percutaneously,” Whitman said in a prepared statement.
Micro Interventional Devices said it is currently pursuing FDA clearance for the device.
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