US-based medical technology company Micro Interventional Devices (MID) has secured the CE mark approval for its transapical access and closure device, Permaseal.
Permaseal is a high-speed delivery system that operates on compliant soft-tissue PolyCor anchor technology, which places an implant on the myocardium via a mini-thoracotomy.
The implant is made from eight PolyCor anchors and one coated, non-absorbable, green braided polyester surgical suture enabling surgeons closer access to the left-ventricle without having to suture the myocardium.
Following the delivery of the implant, Permaseal closes the access site. The access and closure process is quick, reduces blood loss and simplifies the complex structural heart repair processes.
Permaseal facilitates a minimally-invasive procedure which can be repeated multiple times, independent of the operator.
MID founder president and CEO Michael Whitman said: "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."
The secure transapical access and closure study (STASIS) conducted at five European Sites has validated Permaseal after it was observed that it led to reduced opening time, duration of hospital stay, need of transfusion and 12-month mortality, as well as reducing stroke rates to 0%.
Image: A view of MID’s Permaseal. Photo: PRNewsFoto / Micro Interventional Devices.