Permaseal, a transapical access and closure device used in heart surgery has received CE mark approval
Micro Interventional Devices (MID), a creator of minimally invasive and catheter-based compliant fixation technology announced that it received CE Mark approval for Permaseal, which is currently the only transapical access and closure device available for commercial use in the EU.
Permaseal allows surgeons to access and close the left-ventricle instantaneously, reliably and without suturing the myocardium and according to MID, is the world's first device using compliant soft-tissue PolyCor anchor technology.
Permaseal was validated in the STASIS clinical study that was 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%, according to MID.
The company said that Permaseal provides a direct, safe and simple, access and closure site for emerging complex structural heart disease procedures including transcatheter aortic valve replacement (TAVR), transcatheter mitral valve repair (TMVR), patent foramen ovale (PFO), and other minimally invasive cardiac procedures.
Michael Whitman, MID's founder, president and CEO, 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."
"In the near future, PolyCor and MyoLast technologies will be used 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."