Medeon Biodesign announced yesterday that its subsidiary, Aquedeon Medical, Inc., has received approval from the U.S. Food and Drug Administration (FDA) to initiate a pivotal Phase II clinical trial for Duett, its aortic arch repair device. Building on the 35 cases previously approved, the expanded study will now enroll between 72 and 90 patients. The trial aims to validate Duett’s clinical value at scale, marking another critical step toward securing FDA market clearance.
Currently, open surgical repair remains the gold standard for treating aortic dissection and aneurysms, with cases involving the ascending aorta accounting for around 70% of all procedures. However, the surgery is highly complex and time-sensitive. Surgeons must manually suture a synthetic graft to three vital arteries supplying blood to the brain while the heart is arrested under deep hypothermic circulatory arrest (DHCA). Even for highly experienced surgeons, this procedure typically requires 30 to 45 minutes. Clinical data show that when DHCA exceeds 40 minutes, the risk of postoperative stroke and neurological deficits rises sharply, severely impacting patients’ quality of life. By introducing its proprietary vascular anastomosis technology, Duett reduces the suturing time by more than 90%, significantly alleviating the burden on both surgeons and patients.
Dr. Wilson Szeto, a renowned vascular surgeon, Chair of Cardiovascular Surgery at Penn Presbyterian Medical Center, and principal investigator of this IDE clinical trial, commented: “We are pleased that the Phase II study has received FDA approval. Aortic arch repair surgery is complex and technically demanding, and Duett has the potential to transform this field. By simplifying arch reconstruction with innovative technology, Duett can help surgeons and deliver better outcomes for patients. We look forward to advancing its clinical development.”
Aquedeon Medical’s Chief Operating Officer, Tom Palermo, added: “This milestone brings us closer to improving outcomes for aortic arch reconstruction. We are grateful for the continued support of our clinical partners and the FDA, which has enabled us to advance Duett into the next stage of development.”
Dr. Yu-De Chang, Chairman and CEO of Medeon Biodesign, stated: “We are delighted that the FDA, after reviewing Phase I data, has approved Duett to expand into Phase II. This not only validates the research progress we have achieved but also strongly affirms Duett’s clinical value. Patient enrollment and partnership discussions are proceeding as planned. At the same time, our minimally invasive BPH device, Urocross, continues to collect positive clinical data in line with expectations and is on track for regulatory submission, marking a critical step toward commercialization. In addition, our CDMO business is strengthening collaborations with international medical device partners, reflecting in revenue growth. While monthly fluctuations align with clients’ product development cycles, we remain focused on deepening core technologies and services to steadily advance our corporate vision of Medeon 2.0.”
Resource: 益安旗下胸主動脈修復醫材Duett獲美國FDA核准第二階段臨床試驗
