MADISON, Conn., Aug. 31, 2012 (GLOBE NEWSWIRE) -- Vascular Insights LLC announced the start of a multi center dose-finding study conducted by principal investigator Professor Cees Wittens MD, PhD and Yee Lai Lam MD Maastricht University Medical Center, Maastricht, The Netherlands.
The ClariVein® dose-finding study is a randomized controlled trial, which will be conducted in the Maastricht university hospital and 7 additional centers in the Netherlands.
The objective of the study is to identify the ideal sclerosant dosage for great saphenous vein (GSV) occlusion using the ClariVein® system.
"We are confident and excited that this study will demonstrate once again that ClariVein® is the most innovative and safe form of treatment for varicose veins and venous reflux," said John P. Marano, President of Vascular Insights.
"This study shows Vascular Insights' continuing commitment to ensuring the most effective patient outcomes when using the ClariVein® system. We continue to make significant investments in research to generate the data that once again proves the effectiveness of ClariVein®.", said Marano.
600 patients will be included in the study. Patients (CEAP classification C2-C4) who are first time treated for incompetence of the GSV, proven with duplex ultrasound examination.
Professor Wittens stated, "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."
The ClariVein® catheter is a product of Vascular Insights LLC (http://vascularinsights.com) of Madison, Connecticut USA. The company engages in the design, development, manufacture, and marketing of medical devices for the minimally invasive treatment of peripheral vascular disease.
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