Aquedeon Medical has announced its receipt of US Food and Drug Administration (FDA) investigational device exemption (IDE) approval to conduct a staged pivotal clinical trial for the Duett vascular graft system in the USA. The study will be initiated in the second half of 2023, enrolling up to 20 patients at up to five clinical sites for the first stage of the trial.
A press release details that the Duett vascular graft system was uniquely designed to standardise and simplify open surgical thoracic aortic procedures with the goal of providing cardiothoracic surgeons a means to treat the target vessels effectively and efficiently. As a vascular connector, it is designed to connect native aortic arch branch vessels to the surgical graft without the need to circumferentially suture each anastomosis, thus potentially decreasing deep hypothermic circulatory arrest (DHCA) and overall procedure time.
“The introduction of the Duett vascular graft system signifies another addition to the array of tools available to surgeons in the surgical treatment of aortic arch pathology”, said Wilson Szeto, chief of Cardiovascular Surgery at Penn Presbyterian Medical Center (Philadelphia, USA), who is serving as the principal investigator for the clinical trial. Szeto also highlighted his longstanding involvement with the Duett vascular graft system’s evolution, since the company’s inception, and expressed enthusiasm about participating in the imminent clinical trial.
“The Duett vascular graft system has been developed in collaboration with leading cardiothoracic surgeons and the device is aimed at helping to address the complexities and intricacies of thoracic aortic surgeries. Reducing anastomosis time is one major step in addressing this long and complex procedure. We acknowledge [the] FDA’s dedication during the IDE review process and we will continue to work closely with the agency throughout the study with a mission to put this innovative device into the hands of surgeons”, said Tom Palermo, chief operating officer of Aquedeon Medical.