The change to the labeled storage temperature for US marketed product, cleared by the FDA through a 510(k) premarket notification pathway, presents significant advantages; the primary being that DuraGraft no longer requires storage in hospital pharmacy refrigerators. Pharmacy products are not readily available to the surgeon and must be ordered prior to surgery, presenting not only an inconvenience to the surgeon but also an additional step that may cause delays in initiating time-critical surgical procedures. For these reasons, a surgeon may not always opt to use DuraGraft. By making DuraGraft readily available in the operating suite, it can more easily and quickly be integrated into surgical procedures thereby driving adoption and increasing utilization.
Controlled room temperature storage of product also provides substantial logistics and cost saving advantages related to product warehousing and distribution as the product no longer requires cold warehouse storage and shipping, providing significant cost savings that are passed off to distributors and end users. Additionally, product can now be sold directly through hospital procurement channels as opposed to the more challenging hospital pharmacy pathway.
"We believe this FDA 510(k) clearance provides substantial advantages to the surgeon, patient and supply chain of the product and supports our commitment to improving patient outcomes in cardiac surgery," said
About DuraGraft
DuraGraft is the first and only FDA authorized product intended for flushing and storage of the saphenous vein grafts from harvesting through grafting for up to 4 hours in adult patients undergoing Coronary Artery Bypass Grafting (CABG), surgeries. The labelled mechanism of action is the reduction of oxidative damage to maintain the structural and functional integrity of vascular conduits.CABG is the most common type of open-heart surgery in
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