Transapical Access Device Facilitates Structural Heart Disease Procedures

A novel transapical access and closure device helps enter the left ventricular cavity for delivery of interventional instruments.

The Permaseal device is designed to allow surgeons to access and close the left ventricle reliably, and without suturing the myocardium, in a range of minimally invasive cardiac procedures, including transcatheter aortic valve replacement (TAVR), transcatheter mitral valve replacement (TMVR), and patent foramen ovale (PFO). The device employs PolyCor anchoring technology, which simultaneously deploys eight anchors, all connected together by a suture, into the heart tissue at high velocities, slicing open an access hole.

Once the procedure has been completed and the access hole needs to be sealed, the threaded suture loop is pulled upon, and the anchors are drawn together, like a purse string. In a clinical study to validate the device, Permaseal shortened operating time and hospital stay, reduced adverse events (including transfusion needs), and reduced 12-month mortality and stroke rates to zero. The Permaseal device and PolyCor anchoring technology are products of Micro Interventional Devices (MID; Newtown, PA, USA), and have been approved by the U.S. Food and Drug Administration (FDA).

“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 U.S. and European surgeons and their patients,” said Michael Whitman, President and CEO of MID. “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.”

Heart muscle is friable, and tends to tear along natural cleavage planes. As a result, if a slit is made in the myocardium, it begins to tear away from the edge of the incision. The transapical approach is used to safely access the interior of the heart by using a coring device to create a round access port. After the procedure, the tissues are pulled together and sewn, holding the apex together until it heals and fills with scar tissue.

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Micro Interventional Devices