DuraGraft now available in Europe through key distributors
Jupiter, FL–Somahlution announced today that its flagship product DuraGraft is available or will soon be available through key distributors in select EU countries including Germany, the UK, Spain, Austria, Switzerland, the Netherlands, Ireland, Italy and Luxembourg. DuraGraft has also recently received an Australian approval.
DuraGraft is first-in-class and the only CE marked product intended for the flushing, storage and preservation of vascular conduits, which is a pivotal step in coronary artery bypass and peripheral bypass surgeries. As the only clinically proven Endothelial Damage Inhibitor, DuraGraft is critical to successful patient outcomes.
“We are very excited that patients in Europe will now have access to this cutting-edge treatment that has been shown to increase CABG surgery success,” said Somahlution’s CEO, Satish Chandran, Ph.D.
Despite advances in medical management and surgical techniques, there has been little improvement in bypass outcomes. Vein graft failure (VGF) remains one of the leading causes of poor-in-hospital and long-term outcomes after CABG and Peripheral bypass surgeries, with 12-month VGF rates of 46%. These failures most often lead to additional surgeries, further interventions or increased medical management, resulting in increased morbidity and high healthcare costs.
DuraGraft is a simple and safe, pH and ionically balanced sterile solution containing salts, antioxidants and other components that not only prevent damage, but also 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 can also help minimize the risks and liabilities associated with unproven pharmacy-compounded mixtures that are currently in use.
“When used properly, DuraGraft does not interrupt or modify the existing surgical procedure or impact the length of the procedure,” said Chandran. “The 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.”
Five-year clinical data has shown that use of DuraGraft is associated with improved clinical outcomes that are markers of improved long-term vascular graft patency such as, improvements in mortality and MI and reductions in repeat revascularization. The clinical data is consistent with predictions based on in vitro studies with DuraGraft performed by Dr. Thatte of Harvard Medical School, which demonstrated superior preservation of the structure, function and viability of the vascular conduit and associated endothelium.
DuraGraft is currently not commercially available in the US.
About Somahlution, Inc.
Somahlution is a global leader in the development and commercialization of innovative, high value-added solutions to advance clinical performance, define standard of care and improve patient outcomes. Using patented and proprietary technologies, Somahlution is dedicated to providing medical products focused on Ischemia Reperfusion Injury (IRI) to improve healthcare delivery to patients around the world. The company’s flagship product, DuraGraft, is the first Endothelial Damage Inhibitor (EDI) developed to address the pivotal step of vascular conduit handling and storage in bypass and vascular surgeries. For more information on the company please visit www.somahlution.com or www.thesolutionmatters.com.