Marizyme has received de novo clearance from the US Food and Drug Administration (FDA) for its medical device, DuraGraft.
Duragraft has been approved as an intra-operative vascular conduit solution for adult patients undergoing coronary artery bypass grafting (CABG) surgeries.
The device is suitable for the flushing and storing of the saphenous vein grafts that are used in these surgeries.
Its action mechanism involves the reduction of oxidative damage that helps maintain vascular conduits’ structural and functional integrity.
Duragraft has been evaluated in clinical trials, including imaging studies, which demonstrated that saphenous vein grafts treated with this device have lowered graft wall thickening against standard-of-care, saline-treated grafts at 12 months after CABG surgery.
The device is also associated with lower long-term mortality through three years post-CABG surgery.
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The company will now focus on implementing its plans for the commercialisation of the device in the US.
“This is a rapidly growing market that provides Marizyme the opportunity to meet its mission statement and completely change the landscape of cardiac care.”
CABG is said to be the most common type of open-heart surgery in the US and more than 500,000 surgeries are performed every year.
With a diverse pipeline of products, Marizyme is involved in the development and commercialisation of medical technologies for cardiac care.