Marizyme, Inc.
Model Duragraft - Intraoperative Vascular Graft Treatment
FromMarizyme, Inc.
DuraGraft®- Marizyme’ s flagship product is a first-in-class product used during Coronary Artery Bypass Grafting (CABG surgery) to help prevent vein graft failure and its complications. DuraGraft® is a biocompatible intraoperative vascular graft storage and flushing solution that maintains the graft’s endothelial function and structure by preventing ischemic injury.
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intraoperative
- Intraoperative Graft Damage is the principal cause of Vein Graft Failure (VGF). The durability and patency of vein grafts are significantly compromised by Vein Graft Disease (VGD):
- The VGD process begins with endothelial damage that occurs during the grafting surgery itself.
- VGD encompasses the pathophysiological changes that occur in vein grafts following their use in surgical grafting.
- Endothelial Damage, manifested within minutes as pro-inflammatory and pro-thrombogenic changes within the graft, leads to VGD and VGF.
- As VGD progresses, vein grafts lose their ability to adapt to the post-grafting environment, leading to:
- Thrombus formation
- Intimal hyperplasia
- Atherosclerosis
- These may result in:
- Graft stenosis
- Occlusion
- Loss of graft patency
- VGD that progresses to VGF may result in myocardial infarction and the need for repeat revascularization. The success rate of revascularization or re-intervention of a failed graft is very poor. Therefore, addressing early vein graft disease in the primary graft is crucial.
- DuraGraft® is an intraoperative vascular graft treatment that maintains endothelial cell function and structure, reducing the incidence and complications associated with graft failure, thereby improving clinical outcomes.
- DuraGraft improves clinical outcomes by providing a pH balanced and buffered environment which protects against intraoperative Ischemic Reperfusion Injury (IRI).
- DuraGraft is:
- pH balanced – Heparinized saline and autologous blood are not pH balanced.
- Ionically balanced – Critical in maintaining cell osmolarity and membrane integrity.
- Formulated to support the viability and health of the graft post-grafting – L-Arginine is included to support synthesis of nitric oxide during the ischemic period.
- DuraGraft also protects against the two main causes of IRI – oxidative damage and metabolic stress.
- Stabilized antioxidants – Two potent antioxidants (glutathione and ascorbic acid) neutralize the reactive oxygen species that cause oxidative damage during ischemia.
- Supports anaerobic metabolism – Contains components (glucose and high energy phosphates) that support anaerobic metabolism during ischemia, thereby preventing the generation of metabolic stress lesions,
- DuraGraft is clinically tested and approved for use, outside the U.S., for maintaining free arterial and venous vascular grafts.
- DuraGraft has been proven to reduce clinical complications (MI, Repeat Revascularization and MACE) associated with VGF, with statistical significance.
- DuraGraft has been evaluated extensively in clinical studies/registries and is approved for use in Europe and indicated for use during the harvesting and grafting interval of vascular surgery as a treatment to maintain structural and functional integrity of vascular conduits. DuraGraft reduces the incidence of complications associated with graft failure by maintaining normal graft function.
DuraGraft is CE approved for use in the EU and in ex-US countries. DuraGraft is not yet FDA approved in the US.