Medeon announced yesterday (March 19) that its Duett Vascular Graft System, a chest aorta repair device, successfully completed its first human clinical trial (IDE) in the United States in February this year.
Medeon stated that the trial took place at the renowned Penn Presbyterian Medical Center, led by the distinguished vascular surgeon, Dr. Wilson Szeto.
Dr. Wilson Szeto is currently a professor of surgery at the University of Pennsylvania School of Medicine and chief of cardiovascular surgery at Presbyterian Hospital, serving as the principal investigator for this IDE clinical trial.
The patient involved in the clinical trial underwent aortic arch reconstruction surgery due to a rupture in the aortic blood vessel wall, which required excision of the lesioned vessel and replacement with an artificial blood vessel.
Mr. Tom Palermo, Chief Operating Officer of Aquedeon Medical, Inc., a subsidiary of Medeon responsible for this project, stated that Duett, as a key step in improving the complexity of aortic repair surgery, achieved a significant milestone in the development of this innovative product by successfully using it in humans during this clinical trial.
Medeon's Chairman and General Manager, Mr. Yu-te Chang, mentioned that two important innovative projects under Medeon have reached critical stages this year. With Duett crossing the threshold of human use in this first clinical trial, and Urocross, a medical device for the treatment of benign prostatic hyperplasia, entering the late stage of pivotal trials, both moments mark a significant increase in the value of these products.
In addition, the establishment of the Taiwan Production Center for Contract Development and Manufacturing Organization (CDMO) has been completed smoothly, and its key technologies and services have been increasingly favored by international medical device giants, securing orders.
Through this period of establishment, the group has laid a solid foundation for Medeon 2.0, aiming to move forward steadily with a focus on maintaining stable cash flow.
Resource (Mandarin): 益安醫材 在美跨大步
