STARmed has announced that it has obtained CE Mark approval for VENISTAR, an “innovatively designed” electrode that uses radiofrequency energy to treat patients with damaged veins. According to a statement, this minimally invasive electrode provides physicians with the ability to adjust the electrode’s ablation size.
In addition to obtaining the CE Mark approval, South Korea-based STARmed has obtained medical device approval from the Korean Ministry of Food and Drug Safety (MFDS).
VENISTAR includes an adjustable wheel to allow the length of the active tip to be adjusted for various ablation lengths–a first in the vein ablation market. VENISTAR comes in two different active tip sizes, 3cm and 7cm. The 3cm electrode can be adjusted from 0–3cm while the 7cm electrode can be adjusted from 3–7cm.
According to a statement, feedback from the market gave STARmed the idea to also include a LED guide light 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.
VENISTAR works in conjunction with the VVR (Varicose Vein RF) System, which includes the VVR Generator and Cooling Pump. The VVR Generator is user-friendly with a pre-programmed mode for endovenous ablation, while the Cooling Pump circulates coolant throughout the electrode to help prevent thermal damage to normal surrounding tissue–another first in the vein ablation market. STARmed has plans to release other venous ablation devices for the VVR System in the future.
Distribution of VENISTAR and the VVR System within the EU is set to begin in the fourth quarter of 2019. STARmed started their first post-market study with VENISTAR in South Korea for their initial clinical experience, and a first round of the clinical study is expected to be completed by the end of 2019.
A live case with VENISTAR will also be performed by Sang Woo Park during APECS 2019 (Advances in Peripheral EndovasCular Strategies) at Konkuk University Hospital in Seoul, South Korea on November 23-24, 2019.