Aquedeon Medical, Inc. Attains FDA IDE Greenlight for the Duett Vascular Graft System
Thursday, August 24, 2023
Aquedeon Medical, a trailblazing medical device enterprise headquartered in Silicon Valley and renowned for its innovative cardiothoracic solutions, is delighted to announce a momentous achievement. The company has been granted the sought-after FDA Investigational Device Exemption (IDE) authorization, paving the way for a staged pivotal clinical trial of its revolutionary Duett Vascular Graft System within the confines of the United States.
Set to kick off in the latter part of 2023, this trial will encompass a maximum of 20 patients and span across potentially 5 clinical sites during its initial phase. The Duett Vascular Graft System aims to redefine the landscape of open surgical thoracic aortic repair—a procedure of immense complexity that traditionally consumes hours in the treatment of conditions like thoracic aortic aneurysms and dissections.
Traditionally, this intricate procedure demands a considerable span of time, approximately 30 to 45 minutes for each surgical event, dedicated to painstakingly suturing each native branch vessel to the surgical graft. This protracted suturing ritual not only extends the durations of cardiopulmonary bypass and deep hypothermic circulatory arrest (DHCA), but also amplifies the overall risk profile for patients undergoing this intervention.
The ingenious architecture of the Duett Vascular Graft System is primed to streamline and standardize open surgical thoracic aortic procedures. Its fundamental objective is to equip cardiothoracic surgeons with a mode that is more effective and efficient in addressing targeted vessels. Operating as a vascular connector, the system is astutely engineered to seamlessly link native aortic arch branch vessels to the surgical graft without necessitating the complete circumferential suturing of each anastomosis. This groundbreaking approach has the potential to curtail DHCA durations and overall procedural timelines.
The introduction of the Duett Vascular Graft System signifies a noteworthy augmentation to the arsenal available to surgeons engaged in the intricate realm of aortic arch pathology treatment. The collaborative endeavor involving preeminent cardiothoracic surgeons in the development of this system underscores its focal point on grappling with the intricacies intrinsic to thoracic aortic surgeries. A pivotal stride in simplifying this intricate procedure lies in mitigating anastomosis time, highlighting Aquedeon Medical's unwavering dedication to elevating the landscape of medical interventions.