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August 6, 2019
StarMed's VeniStar Obtains CE Mark for Endovenous Radiofrequency Ablation
August 7, 2019—StarMed Co., Ltd. announced that it has obtained European CE Mark approval for its VeniStar device, a minimally invasive electrode that uses radiofrequency (RF) energy to treat damaged veins. Additionally, the company has obtained medical device approval from the Korean Ministry of Food and Drug Safety.
According to StarMed, the VeniStar allows physicians to adjust the electrode’s ablation size with an adjustable wheel to move the active tip to provide various ablation lengths. The device is available in active tip sizes of 3 cm (adjustable from 0–3 cm) and 7 cm (adjustable from 3–7 cm). It includes an LED guidelight at the electrode’s tip for visibility to the treatment site as well as a spiral active tip that provides flexibility to help navigate through tortuous veins. The VeniStar works with the company's varicose vein RF (VVR) system, which includes the VVR generator and cooling pump.
Distribution of VeniStar and the VVR System within the European Union will begin in the fourth quarter of 2019. StarMed initiated the first postmarket study with VeniStar in South Korea for their initial clinical experience. The first round of the clinical study is expected to be completed by the end of 2019.
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