Chinese MedTech company Zylox-Tonbridge has received marketing approvals for five of its devices from the UAE’s Ministry of Health and Prevention. The company also plans to expand its presence in the Middle East.
The Zylox-Tonbridge devices that received approval are the ZENFluxion drug-coated PTA balloon catheter; ZENFlow HP PTA balloon catheter; ZENFlow PTA balloon catheter; ZENFlex peripheral stent system; and ZENFLEX Pro peripheral drug-eluting stent system.
PTA balloon catheters and peripheral stents are used to perform percutaneous transluminal angioplasty (PTA). The procedure is indicated to treat peripheral vascular disease, which is a narrowing of the blood vessels. If untreated the disease can cause chronic wounds on the limbs and increase the risk of heart attack or stroke. The risk of developing peripheral vascular disease increases with age, with its prevalence being around 20–30% in adults aged 80 years and older, according to the US CDC.
As part of the procedure, a PTA balloon catheter is inserted into the peripheral vessels and is then inflated at the narrowed area to open the artery and restore blood flow. The peripheral stent is inserted, in many cases, into the newly opened area of the artery to help keep the artery from narrowing or closing again.
The fast-growing UAE market for medical devices is expected to be worth $2.8bn (Dh10.28bn) by 2030, according to GlobalData’s market model. The PTA balloon catheters market segment is expected to generate $1.7m in sales in 2030.
Recent advancements in PTA procedures include Alucent Biomedical’s light-activated, drug-coated balloon catheter technology. The device was approved by the US Food and Drug Administration in August 2023. In January 2024, Summa Therapeutics performed the first injectable angioplasty with its Finesse Injectable balloon catheter. The device can perform both diagnostic and therapeutic functions by serving as a crossing catheter, diagnostic angiography catheter and angioplasty catheter.
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By GlobalData
Zylox-Tonbridge has taken steps to expand into other emerging markets in recent months. In August 2023, the company’s ZENFlow Tiger LD PTA dilatation catheter was approved by the Brazilian Health Regulatory Agency. The company also expanded access to its vascular guidewire products by forming a strategic partnership with Guangdong Hicicare Science and marketed them under a co-branded label in China.
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- Source: https://www.medicaldevice-network.com/news/chinas-zylox-tonbridge-looks-to-expand-into-the-gulf-region/
