DuraGraft vascular conduit solution receives the CE mark


Somahlution announced on 22 September 2014 that it has received CE mark approval for DuraGraft, the first-in-class endothelial damage inhibitor (EDI) that uniquely protects vascular endothelium function and its associated architecture. DuraGraft, used as a vascular conduit solution, is a pivotal step in successful coronary artery bypass graft and peripheral bypass surgeries.

“Despite advances in medical management and surgical techniques, there has been little improvement in bypass outcomes. Vein graft failure remains one of the leading causes of poor-in-hospital and long-term outcomes after coronary artery bypass graft and peripheral bypass surgeries. Recent studies show that the 12-month coronary artery bypass vein graft failure and peripheral bypass vein graft failure rates are 46% and 61% respectively. These failures most often lead to additional surgeries, further interventions or increased medical management, resulting in increased morbidity and high healthcare costs,” says Satish Chandran, Somahlution’s chief executive officer.

Leading experts have shown that preserving the structure and function of vascular endothelium is critical for reducing vein graft failure rates and for improving long-term outcomes in both coronary artery bypass graft and peripheral bypass surgeries. Researchers from Duke Clinical Research Institute evaluated the impact of vascular conduit storage solutions on vein graft failure rates and clinical outcomes through a sub-analysis of data from the prospective, randomised Prevent-IV trial, one of the largest studies conducted to date evaluating vein graft failure following coronary artery bypass graft surgery. The results demonstrated that the single variable, graft preservation solution, significantly affected both vein graft failure rates and clinical outcomes; standard of care solutions that are not approved for vascular conduit preservation such as, saline and blood-based solutions, performed poorly and were associated with statistically higher vein graft failure rates and poorer clinical outcomes compared to patients whose grafts were stored in a “buffered-type solution” such as DuraGraft.

Data from a Somahlution-sponsored clinical study that tested DuraGraft head-to-head against a saline-based solution, demonstrated that DuraGraft used in coronary artery bypass graft surgery was associated with significantly improved clinical outcomes relative to patients whose vascular conduits were stored in a standard of care solution (heparin-dosed saline). The 600 patient study evaluated the Impact of DuraGraft in both short-term and long-term clinical outcomes in patients undergoing first-time coronary artery bypass graft surgery. DuraGraft, when compared to the saline group, demonstrated improved clinical outcomes and was shown to reduce myocardial infarction rates by 53%, repeat revascularisation by 48% and mortality by 18%. “Improvements associated with the use of DuraGraft will likely result in improved vein graft failure rates and quality of life for patients,” says Chandran.

Chandran said that DuraGraft is a simple-to-use, pH and osmotically balanced sterile solution containing salts, antioxidants and other components that are pro-endothelial conditioning and pro-vasomotor function preserving. DuraGraft is intended for the preservation, storage and flushing of vascular conduits prior to grafting in vascular surgeries. It is a premeasured, ready-to-use solution that is manufactured under cGMP conditions that may help to minimise the risks associated with the use of pharmacy compounded solutions that are not subjected to rigorous manufacturing controls of a cGMP process.

“When used properly, DuraGraft does not interrupt or modify the existing surgical procedure or impact the length of the procedure,” says Chandran. “DuraGraft solution is manufactured using USP/EP grade materials, in a controlled environment under cGMP in an ISO 13485 certified facility for maximum quality control to ensure patient safety.”

Somahlution’s chairman Vithalbhai Dhaduk, a practising physician adds, “There is a significant unmet need for new technologies designed specifically to improve vein graft performance. The future success of coronary artery bypass surgery in managing cardiovascular diseases and improving patient outcomes is dependent on it. Despite over 50 years of coronary artery bypass graft surgery, this pivotal step in the process of maintaining vascular conduit health had gone unnoticed until now. As the data now indicates, DuraGraft’s role in bypass surgery is a critical one, cementing the gaps and in delivering better outcomes to patients.”

DuraGraft, Invented by Hemant Thatte of Harvard, was licensed to Somahlution by the Veteran’s Administration. Somahlution officially launched DuraGraft in Europe at the European Association of Cardio-Thoracic Surgery (EACTS) 28th Annual Meeting in Milan, Italy. DuraGraft is currently not commercially available in the US.