Zylox-Tonbridge Medical Technology has received regulatory approval for its ZYLOX Unicorn vascular closure device (VCD) in Indonesia.
This approval represents the first international market clearance for the device, a product tailored to address unmet needs in vascular intervention.
The device is China’s first domestically developed VCD, providing an extended closure range from 5 French (Fr) to 22Fr.
It is compatible with large-bore access sites equal to 8Fr and above, widening its clinical applications.
The pre-close technique and at least two devices are necessary for sheath sizes less than 8Fr.
The device showed efficacy and safety in premarket trials and was authorised for marketing in China last June.
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By GlobalDataAccording to the company, this VCD is intended for the percutaneous suture delivery to close the common femoral artery access area in individuals who have received interventional or diagnostic catheterisation procedures.
With the system’s approval in Indonesia, local physicians and their patients gain access to comprehensive vascular intervention solutions.
Zylox-Tonbridge noted that its overseas business has seen rapid growth, with a revenue of nearly $3.1m last year and a four-year compound annual growth rate (CAGR) of 87%.
This year, the company increased its international brand visibility by showcasing key products at various worldwide congresses.
Zylox-Tonbridge plans to improve localisation and market entry as part of its ongoing growth strategy.
