Marizyme, Inc. (OTCQB: MRZM), a global biotechnology company developing products to reduce the burden of ischemia-reperfusion injury in tissue grafting, organ transplant, and other surgical indications, has announced as of August 2020 the Vienna Heart Center North Floridsdorf of Vienna, Austria was the first clinic worldwide to use the company’s flagship product, DuraGraft® as the standard-of-care for flushing and storage of the saphenous vein grafts from harvesting through grafting in Coronary Artery Bypass Grafting (CABG) patients.
Vienna Heart Center North Floridsdorf, an internationally recognized leader, is Austria’s latest super-specialty center. Opening in 2019, it is one of Europe’s most modern Centers. The hospital has a Heart and Vascular Center with a focus on aortic procedures and minimally invasive cardiovascular procedures and all techniques of CABG. The center performs approximately 500 CABG surgeries per year and is part of the ongoing DuraGraft EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits with DuraGraft to Evaluate the Safety and Performance of DuraGraft (VASC). Based on the performance of DuraGraft in improving patient outcomes, the Cardiac Surgery Center at Vienna Heart Center North Floridsdorf in August 2020 recognized DuraGraft as thestandard-of-care for CABG surgeries.
“We have seen encouraging evidence that reinforces the importance of appropriate graft treatment during surgery and the role of DuraGraft in significantly improving outcomes in all patients. Additionally, we have observed significant myocardial protection utilizing DuraGraft during CABG, where we have implemented a recent study,” said Associate Professor Priv. Doz. Dr. Bernhard Winkler at Vienna Heart Center North Floridsdorf.
The Chief of Cardiac Surgery at the hospital, Prof. Dr. Martin Grabwenwöger, said, “Saline, blood and buffered solutions have long been considered the standard-of-care for CABG surgery; however, studies have shown that DuraGraft outperforms its predecessors. We are thrilled to have DuraGraft as our new standard-of-care for graft treatments during CABG Surgery.”
“The endothelial damage inhibitor, DuraGraft, has shown promising results in several preclinical studies and large-scale clinical investigations to adequately protect and preserve vascular conduits and in improving clinical outcomes. Therefore, its use as standard-of-care for vascular conduit storage and prevention of ischemic injury is not surprising,” said Prof. Dr. Maximilian Emmert from the German Heart Center Berlin, Germany and PI of the VASC Registry.
Dr. Neil J. Campbell, Chief Executive Officer of Marizyme, stated, “Clinical evidence generated by independent researchers around the world have shown that DuraGraft improves CABG clinical outcomes resulting in DuraGraft providing a value proposition to patients, cardiac centers and healthcare systems worldwide. We at Marizyme are extremely excited to offer this product to CABG patients.”
About CABG and DuraGraft
When patients with heart disease undergo CABG surgery, free vein or arterial grafts harvested from the leg, arm or chest are frequently used to bypass occluded coronary arteries; about 90% of CABG surgeries use at least one free vein graft. In most cases, in the time between harvesting and bypass grafting, the free graft is stored in saline or autologous blood which do not protect the graft from ischemic injury thereby increasing the risk of ischemia-reperfusion injury and graft disease and ultimate failure leading to post-CABG myocardial infarction and the need for repeat revascularization procedure.
DuraGraft is a CE-marked product that protects vascular grafts against ischemic injury and is the only product approved for graft protection and preservation during bypass and other vascular surgeries. DuraGraft protects graft tissue from harvesting through anastomosis and is used during vascular surgery (including CABG) as a treatment to maintain the structural and functional integrity of isolated vascular grafts. The use of DuraGraft is associated with the reduction of post-CABG complications associated with graft disease and failure: Myocardial Infarction, Repeat Revascularization, and MACE.
Clinical studies in more than 3,000 patients support the long-term safety and efficacy of DuraGraft. The use of DuraGraft in CABG surgery is associated with statistically significant lower risks for clinical complications following CABG; 45% reduction in non-fatal myocardial infarction (MI) (p <.0001), 35% reduction in repeat revascularization (p=0.037), and 19% reduction of MACE (a composite of all major adverse cardiac events) (p=0.005) (Haime et al. 2018).