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First Patient Enrolled in Aquedeon Medical's IDE Study for Duett™ Vascular Graft System

Monday, March 18, 2024

Aquedeon Medical, a prominent medical device company based in Silicon Valley, is thrilled to announce a major achievement as it begins its investigational device exemption (IDE) clinical trial for the Duett™ Vascular Graft System. The procedure for aortic arch surgical reconstruction typically involves replacing a diseased aortic segment with a synthetic surgical aortic vascular graft, often made of materials like polyester.

Traditionally, surgeons would painstakingly reattach the three vessels supplying blood to the brain and left arm using time-consuming hand-sewn circumferential surgical anastomoses, with each connection taking approximately 15 minutes per vessel. However, the Duett Vascular Graft System shows promise in significantly reducing the time required for vessel connection. This surgical procedure is performed under hypothermic circulatory arrest (HCA), where the patient's body temperature is lowered from 37°C to 28°C, the heart is temporarily stopped, and the body is supported by a cardiopulmonary bypass machine. Prolonged durations of HCA pose an increased risk of neurological complications due to temporary decreases in blood flow to the brain and lower body.

Developed in collaboration with leading cardiothoracic surgeons, the patented Duett Vascular Graft System aims to simplify the complexities of thoracic aortic surgeries. By reducing anastomosis time, it represents a significant advancement in streamlining this intricate and lengthy procedure.




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