Latest news with #vascularintervention
Yahoo
27-05-2025
- Business
- Yahoo
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. 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. According 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. "Zylox-Tonbridge's Unicorn VCD gains clearance in Indonesia" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Associated Press
27-05-2025
- Business
- Associated Press
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 Device's first international market clearance and the Company's first market authorization in Southeast Asia—representing a significant step forward in its international expansion strategy. As China's first domestically developed vascular closure device, the ZYLOX Unicorn™ VCD offers an extended closure range from 5F to 22F and is compatible with large-bore access sites (≥8F), enabling broader clinical applications and addressing previously unmet needs in vascular intervention. Designed to meet global standards, the ZYLOX Unicorn™ VCD has demonstrated strong safety and efficacy in premarket clinical trials. The system facilitates effective vascular closure, shortens patient immobilization time, and reduces the risk of puncture-site complications—delivering high-quality, affordable care to a wider patient population. The product was granted marketing authorization in China in June 2024. Indonesia, the world's fourth most populous country, represents a major opportunity for expanding access to advanced vascular intervention solutions. The approval of the ZYLOX Unicorn™ VCD in this key market will provide local physicians and patients with greater access to comprehensive vascular intervention solutions and support Zylox-Tonbridge's continued expansion across Southeast Asia. Zylox-Tonbridge's overseas business has grown rapidly in recent years, generating approximately USD 3.1 million in revenue in 2024, with a four-year compound annual growth rate (CAGR) of 87%. The Company's business footprint spans Europe, the Americas, the Middle East, and Africa, covering countries such as France, Germany, Italy, Spain, Turkey, Saudi Arabia, Argentina, Brazil, and South Africa. In 2025, Zylox-Tonbridge showcased key products at major global congresses including LINC, PAIRS, CICE, and ESOC, boosting its international brand visibility. Looking ahead, Zylox-Tonbridge remains committed to its mission of 'Innovation for Quality Life' and will continue expanding global access to high-quality, affordable treatment solutions through enhanced localization and strategic market entry. View original content: SOURCE ZYLOX-TONBRIDGE
Yahoo
27-05-2025
- Business
- Yahoo
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 Device's first international market clearance and the Company's first market authorization in Southeast Asia—representing a significant step forward in its international expansion strategy. As China's first domestically developed vascular closure device, the ZYLOX Unicorn™ VCD offers an extended closure range from 5F to 22F and is compatible with large-bore access sites (≥8F), enabling broader clinical applications and addressing previously unmet needs in vascular intervention. Designed to meet global standards, the ZYLOX Unicorn™ VCD has demonstrated strong safety and efficacy in premarket clinical trials. The system facilitates effective vascular closure, shortens patient immobilization time, and reduces the risk of puncture-site complications—delivering high-quality, affordable care to a wider patient population. The product was granted marketing authorization in China in June 2024. Indonesia, the world's fourth most populous country, represents a major opportunity for expanding access to advanced vascular intervention solutions. The approval of the ZYLOX Unicorn™ VCD in this key market will provide local physicians and patients with greater access to comprehensive vascular intervention solutions and support Zylox-Tonbridge's continued expansion across Southeast Asia. Zylox-Tonbridge's overseas business has grown rapidly in recent years, generating approximately USD 3.1 million in revenue in 2024, with a four-year compound annual growth rate (CAGR) of 87%. The Company's business footprint spans Europe, the Americas, the Middle East, and Africa, covering countries such as France, Germany, Italy, Spain, Turkey, Saudi Arabia, Argentina, Brazil, and South Africa. In 2025, Zylox-Tonbridge showcased key products at major global congresses including LINC, PAIRS, CICE, and ESOC, boosting its international brand visibility. Looking ahead, Zylox-Tonbridge remains committed to its mission of "Innovation for Quality Life" and will continue expanding global access to high-quality, affordable treatment solutions through enhanced localization and strategic market entry. View original content: SOURCE ZYLOX-TONBRIDGE Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
