[ 메디채널 김갑성 기자 ] CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.

SUNNYVALE, Calif., Aug. 12, 2025 -- Aquedeon Medical Inc. (AMI) is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the expansion of its Investigational Device Exemption (IDE) clinical trial evaluating the Duett Vascular Graft System (Duett System), a novel device designed to facilitate open surgical repair of aortic arch aneurysms and dissections, including hybrid procedures.

AMI is developing the Duett System to address a critical need in open surgical thoracic aortic arch reconstruction, a complex and high-risk procedure typically performed during deep hypothermic circulatory arrest (DHCA) while the patient is on cardiopulmonary bypass. DHCA duration is a critical factor that directly impacts patient outcomes.

During arch reconstruction, the diseased portion of the aorta is excised and replaced with a prosthetic polyester graft. This graft is sutured to the native aorta, and each of its branches is connected to the three major arch vessels supplying blood to the brain and upper body. This portion of the surgery—suturing the graft branches to native vessels—is technically demanding and time-consuming, contributing to prolonged DHCA, which is associated with increased neurological and cardiac risks.

The Duett System is engineered to simplify and accelerate the vascular anastomosis process, with the goal of reducing DHCA duration and re-establishing cerebral perfusion more rapidly.

AMI launched its two-stage IDE clinical trial in 2024 to evaluate the safety and effectiveness of the Duett System. With the recent FDA approval, the study will now expand to enroll up to 90 patients across additional clinical sites in the United States. This expansion aims to further validate the system's clinical benefits and procedural efficiency.

"It is exciting that Aquedeon has received FDA approval to expand the Duett IDE study to 90 patients. Open aortic arch surgery is complex and technically demanding. The Duett technology has the potential to transform the field by providing aortic surgeons with an innovative tool to facilitate arch reconstruction and enhance care for patients with aortic disease. We look forward to continued investigation with this novel technology," said Dr. Wilson Szeto, University of Pennsylvania, Principal Investigator.

"This milestone brings us one step closer to improving outcomes for patients undergoing complex aortic arch reconstruction," said Tom Palermo, Chief Operating Officer of Aquedeon Medical. "We are grateful for the continued support of our clinical partners and the FDA as we advance the Duett System through the next stage of evaluation."

For more information about Aquedeon Medical and the Duett Vascular Graft System, please visit www.aquedeonmedical.com.

Media Contact: Thomas Palermo, Email: tom.palermo@aquedeonmedical.com.