Zylox-Tonbridge Medical Technology announced that its ZYLOX Unicorn Vascular Closure Device (VCD) has received regulatory approval in Indonesia.
It is the first international regulatory approval for the ZYLOX Unicorn VCD, and the company’s first market authorisation in Southeast Asia.
ZYLOX Unicorn VCD represents China’s first domestically developed vascular closure device, providing an extended closure range.
The device provides a closure range between 5F and 22F and is compatible with large-bore access sites (≥8F).
Its compatibility allows for broader clinical applications, addressing previously unmet needs in vascular intervention.
The device has shown strong safety and efficacy in premarket clinical trials.
The system facilitates effective vascular closure, shortens patient immobilisation time, and reduces the risk of puncture-site complications.
This enables the delivery of high-quality, affordable care to a wider patient population.
The product was granted marketing authorisation in China in June 2024.
Indonesia, being the world’s fourth most populous country, presents a significant opportunity for expanding access to advanced vascular intervention solutions.
The approval of the ZYLOX Unicorn VCD will provide local physicians and patients with greater access to comprehensive vascular intervention solutions.
Also, the system will support Zylox-Tonbridge’s continued expansion across Southeast Asia.
Zylox-Tonbridge’s overseas business has experienced rapid growth, generating around $3.1m in revenue in 2024, with a four-year compound annual growth rate (CAGR) of 87%.
The company’s footprint spans Europe, the Americas, the Middle East, and Africa, covering Argentina, Brazil, France, Germany, Italy, Saudi Arabia, South Africa, Spain, and Turkey.
This year, Zylox-Tonbridge showcased key products at major global congresses, including CICE, ESOC, LINC, and PAIRS, boosting its international brand visibility.
Zylox-Tonbridge said it will continue expanding global access to high-quality, affordable treatment solutions through enhanced localisation and strategic market entry.
