Medeon Biodesign announced on 27 September that the Cross-Seal, a large-bore vascular closure device developed in collaboration with its authorised partner, Terumo, has been notified by the US FDA of its PMA Approval, making Medeon the first company in Taiwan with PMA for Class III medical devices, and will be able to recognise a milestone payment of US$1 million.

Medeon said that the the Cross-Seal device had gone through animal tests, the first human trial, and the EMA approval for clinical trials, Medeon has cooperated with Terumo to start the U.S. pivotal trial, and then filed an application to the U.S. FDA for pre-market review by the Modular PMA.

In addition, the company further submitted the documents of preclinical testing, manufacturing methods, engineering testing, and clinical trials to the U.S. FDA, and completed the cGMP on-site inspection and follow-up review before obtaining the PMA Approval, which now enters the U.S. market.

In recent years, percutaneous catheterization procedures (such as Transcatheter Aortic Valve Implantation, or TAVI) have become more mature and popular, and the indications have gradually expanded from a small number of high-risk patients to low and medium-risk patients, with the overall market exceeding US$5 billion, and the compound annual growth rate reaching double digits.

Cross-Seal, a large-bore closure device, is an indispensable part of such surgeries, and the market has grown accordingly. It provides a revolutionary solution for interventional surgeries with large arterial incisions, with the significant advantages of suture-based device, and an innovative design that completes the suture through a simple three-step process, which greatly improves the stability of the operation and the effect of haemostasis.

Chairman and CEO of Medeon, Dr. Yue-Teh Jang, said that Cross-Seal's achievement of Class III PMA not only proves the product development strength of the company's team, but is also a demonstration of the capacity of Taiwan's medical device R&D.

After 10 years of testing and trials, the product has reached international standards. With the continuous support of the industrial ecosystem, Medeon expects that more medical device R&D projects will reach this milestone in the future, and be able to launch in different markets.