Aquedeon Nets IDE Approval for Duett Vascular Graft

Aquedeon Medical, a Silicon Valley device company specializing in novel cardiothoracic colutions, has received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to begin a stage pivotal trial for its Duett vascular graft system in the U.S.
 
The company said the study will start in the second half of 2023, enrolling up to 20 patients at five clinical sites for the trial’s first stage.
 
Duett was designed to standardize and simplify open surgical thoracic aortic procedures, when can take several hours. The goal of Duett is to provide cardiothoracic surgeons  a means to treat the target vessels effectively and efficiently.
 
The vascular connector connects native aortic arch branch vessels to the surgical graft without needing to circumferentially suture each anastomosis, potentially decreasing deep hypothermic circulatory arrest (DHCA) time 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”, Dr. Wilson Szeto, Chief of Cardiovascular Surgery at Penn Presbyterian Medical Center and Professor of Surgery at the University of Pennsylvania School of Medicine, who is serving as the Principal Investigator for the clinical trial, told the press.
 
“The Duett Vascular Graft System has been developed in collaboration with leading cardiothoracic surgeon 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 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, COO of Aquedeon Medical.