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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The company will now focus on implementing its plans for the commercialisation of the device in the US.

Marizyme CEO David Barthel said: “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.”

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.