Somahlution Announces Study Results Showing DuraGraft® Vascular Graft Treatment Improves Long-Term Outcomes in Coronary Artery Bypass Grafting Surgery
JUPITER, Fla., Oct. 4, 2016 /PRNewswire/ -- Somahlution, a global biotechnology company leading the development of products to reduce the burden of ischemia reperfusion injury in tissue grafting, organ transplant and other surgical indications, today announced presentation of new data showing the company's DuraGraft® vascular graft treatment significantly improves long-term outcomes in coronary artery bypass grafting (CABG) surgery. Results were presented today at the European Association for Cardio-Thoracic Surgery (EACTS) annual meeting in Barcelona, Spain.
The retrospective, non-randomized study conducted at VA Boston Healthcare System (MAVERIC) evaluated the Real World Evidence of DuraGraft use in a total of 2,436 consecutive patients who underwent CABG surgery with at least one saphenous vein graft. DuraGraft vascular graft treatment was associated with statistically significant lower risks for non-fatal myocardial infarction, repeat revascularization, and a composite of all major adverse cardiac events (MACE) over 12+ years of patient follow up. The risk of myocardial infarction beginning as early as 30 days following surgery was reduced by 36% (p=0.0003). This treatment effect on myocardial infarction rate was even more pronounced beginning at three years following surgery, with an adjusted risk reduction of 50% (p=0.0001). DuraGraft treatment also provided 38% long-term reductions in the need for repeat revascularization (p=0.03) and a 29% reduction in the occurrence of all MACEs (p=0.02).
"These new findings highlight that the protective effects of DuraGraft treatment present significant advantages in long-term clinical follow up post-CABG surgery," said Miguel Haime, MD, the lead investigator of the study. "These results provide further supporting evidence indicating the importance of graft treatment during surgery and its potentially significant role in reducing graft failure for thousands of CABG patients each year."
In CABG, the standard of care for coronary heart disease, saphenous vein grafts are commonly used as bypass conduits for surgical revascularization. Pathophysiological changes that occur in vein grafts within minutes during the surgical procedure can compromise the durability and patency of the graft and increase the risk of vein graft disease. DuraGraft is a first-in-class vascular graft treatment designed to prevent vein graft failure post-CABG by effectively treating the graft during surgery.
"DuraGraft represents a pivotal innovation in CABG that has significantly improved clinical outcomes and has the potential to change the bypass surgery landscape," said Satish Chandran CEO of Somahlution.
DuraGraft is the first commercial product based on the GALA technology platform that is licensed by Somahlution from the U.S. Department of Veterans Affairs. DuraGraft treatment was launched in Europe and other global markets in 2015 for CABG and peripheral bypass indications, and is currently not commercially available in the U.S.
About Somahlution
Somahlution is a global leader in the development and commercialization of graft treatments based on the GALA technology platform to reduce the burden of ischemia reperfusion injury in tissue grafting, organ transplant and other surgical indications. The company's flagship product, DuraGraft, is a vascular graft treatment that improves clinical outcomes by reducing the incidence and complications of graft failure. DuraGraft enhances CABG outcomes by significantly reducing major cardiac events such as repeat revascularization and myocardial infarction.