Zylox Medical Device Co.

Zylox Medical's ZENFluxion™ and ZENFLEX Pro™ Received CE Certificate


Zylox Medical announced that its ZENFluxion™ Drug Coated PTA Balloon Catheter and ZENFLEX Pro™ Peripheral Drug eluting Stent System have received CE Certificate on October 28 (2020).

 

ZENFluxion™ DCB is indicated for Percutaneous Transluminal Angioplasty (PTA) of stenosis or occlusion lesions in iliac, femoral or popliteal arteries. It contains 3 different series respectively compatible with the guidewires 0.014”, 0.018”, 0.035”. The ZENFLEX Pro™ DES is indicated for improving luminal diameter in the treatment of de novo or re-stenotic symptomatic lesion(s) in native vascular disease of the above-the-knee femoropopliteal arteries. Both of the balloon and the stent are coated with the antiproliferative drug paclitaxel on its outer surface to help prevent the arteries from narrowing again. Zylox's proprietary drug coating technology can effectively control paclitaxel crystallization and obtain a uniform and stable coating layer on the device surface. The dense and integrated paclitaxel microcrystal layer can prevent the early drug flaking during the preparation and handling of the device and maximizes drug transfer efficiency to the vessel wall.


According to Caradu, Caroline et al., (2019)1, Peripheral Artery Disease (PAD) affects more than 200 million people worldwide, most of them over age 50. The drug-coated balloons market by revenue is expected to grow at a CAGR of 15% during the period 2019-2025,The market is growing significantly due to the surge in incidence/prevalence of cardiovascular diseases, especially peripheral artery and coronary artery diseases across the globe2. Based on this, Zylox Medical is expecting to develop more advanced technology and provide high-quality products to healthcare consumers and providers around the world.

 

In addition, Zylox's DCB also has obtained National Medical Products Administration (NMPA) approval on November 10 (2020), which enables Zylox Medical to offer more products and services in Chinese market.


 

References:

 

1. Caradu, Caroline et al. Systematic review and updated meta-analysis of the use of drug-coated balloon angioplasty versus plain old balloon angioplasty for femoropopliteal arterial disease. Journal of Vascular Surgery. Volume 70, Issue 3, 981-995.e10.

 

2. Research and Markets. 2020. Drug-Coated Balloons Market - Global Outlook and Forecast 2020. Accessed November 17, 2020. https://www.researchandmarkets.com/reports/5182940/drug-coated-balloons-market-global-outlook-and?w=12.