DuraGraft works by reducing oxidative damage which maintains the structural and functional integrity of vascular conduits, and is indicated for adults undergoing CABG surgeries, for flushing and storage of the saphenous vein grafts during the surgery
Marizyme secures FDA approval for DuraGraft solution. (Credit: Piron Guillaume on Unsplash)
US-based medical technology company Marizyme has received the US Food and Drug Administration (FDA) de novo approval for its vascular conduit solution, DuraGraft.
DuraGraft is indicated for adults undergoing Coronary Artery Bypass Grafting (CABG) surgeries, for flushing and storage of the saphenous vein grafts during the surgery.
It works by reducing oxidative damage which maintains the structural and functional integrity of vascular conduits.
In the clinical studies, saphenous vein grafts treated with DuraGraft showed to reduce graft wall thickening compared to standard-of-care, at 12 months post-CABG surgery.
The use of DuraGraft is also linked to a reduction in long-term mortality through three years post-CABG surgery, said the medical technology company.
Marizyme CEO David Barthel said: “DuraGraft has the potential to change the landscape of cardiac care. With this significant milestone reached, our company, Marizyme, can now present this breakthrough to cardiac surgeons and their CABG patients.
“This is a rapidly growing market that provides Marizyme the opportunity to meet its mission statement and completely change the landscape of cardiac care.”
Marizyme said that DuraGraft is the first and only medical product to receive FDA approval for use as an intra-operative vascular conduit storage and flushing during CABG surgeries.
It is the only approved product available for this indication in Europe and other countries and is the only patented product for this indication in CABG and other surgeries.
The patent portfolio of DuraGraft includes granted patents and pending applications in more than 30 countries, including the US, Europe, Australia, India, Argentina, South Africa, Mexico, and several Asian countries.
With the FDA de novo approval, the US medical device maker plans to commercialise DuraGraft in the US, focusing on hospital-integrated networks using its own direct sales force.