US EditionZYLOX Unicorn™ Vascular Closure Device Receives Regulatory Approval in Indonesia
- Zylox-Tonbridge announced on May 26, 2025, in Hangzhou, China, that its ZYLOX Unicorn Vascular Closure Device received regulatory approval in Indonesia.
- Following its regulatory clearance in China in mid-2024, Zylox-Tonbridge has now achieved its inaugural market approval in Southeast Asia with the product's authorization in Indonesia.
- The ZYLOX Unicorn VCD is the first vascular closure device created within China, featuring a closure capability spanning 5F to 22F and designed to accommodate large-bore access sites.
- Premarket clinical trials demonstrated the device’s strong safety, effective vascular closure, reduced puncture-site complications, and shortened patient immobilization time.
- The approval will enhance the availability of advanced vascular intervention technologies in Indonesia and contribute to Zylox-Tonbridge’s ongoing growth throughout the Southeast Asian region.
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77 Articles
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ZYLOX Unicorn™ Vascular Closure Device Receives Regulatory Approval in Indonesia
HANGZHOU, China, May 26, 2025 /PRNewswire/ -- Zylox-Tonbridge Medical Technology Co., Ltd. ("Zylox-Tonbridge" or the "Company") today announced that its proprietary ZYLOX Unicorn™ Vascular Closure Device (VCD) has received regulatory approval in Indonesia. This marks the ZYLOX Unicorn™ Vascular Closure…
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May 27, 2025—Terumo Interventional Systems, a division of Terumo Corporation, announced the early commercial availability of its FDA-approved Roadsaver carotid stent system. According to Terumo Interventional Systems, a limited market release of the Roadsaver carotid stent system is planned for summer 2025, and a full market release is anticipated in fall 2025. As noted in the company’s press release, the Roadsaver carotid stent system, when use…
Zylox-Tonbridge's Unicorn VCD gains clearance in Indonesia
Zylox-Tonbridge Medical Technology has received regulatory approval for its ZYLOX Unicorn vascular closure device (VCD) in Indonesia.The post Zylox-Tonbridge’s Unicorn VCD gains clearance in Indonesia appeared first on Medical Device Network.
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