Vascular Insights, a manufacturer of peripheral vascular devices, has started a multi-center dose-finding study of its non-thermal vein ablation ClariVein system, designed to treat venous reflux diseases.
The ClariVein system uses endovascular technique to eliminate the risk of nerve or skin damage or parathesia from thermal energy and to remove the need for catheter or guide wire exchanges.
The controlled, randomized trial, which will enroll 600 patients, is designed to identify the ideal sclerosant dosage for great saphenous vein occlusion using the ClariVein system.
The company said study will be conducted in the Maastricht university hospital and 7 additional centers in the Netherlands.
Vascular Insights president John Marano said the company is confident that the study will demonstrate that ClariVein is the safe form of treatment for varicose veins and venous reflux.
"This study shows Vascular Insights’ continuing commitment to ensuring the most effective patient outcomes when using the ClariVein system," Marano added.
"We continue to make significant investments in research to generate the data that once again proves the effectiveness of ClariVein."
Maastricht University Medical Center spokesperson and study principal investigator professor Cees Wittens said, "Because the ClariVein method allows safe treatment of venous segments along nerves, we may significantly improve the optimal treatment of GSV and small saphenous vein (SSV) incompetence by extending the treatment length beyond the traditional approach."