MADISON, Conn., July 31, 2012 (GLOBE NEWSWIRE) -- Vascular Insights LLC. announced the start of the Maradona clinical trial conducted by principal investigators Michel Reijnen, MD, PhD Vascular Surgeon Rijnstate Hospital, Arnhem, The Netherlands and Jean-Paul de Vries, MD, PhD Vascular Surgeon St. Antonius Hospital Nieuwegein, The Netherlands.
The clinical trial compares ClariVein® in the MOCA™ procedure to radio frequency ablation (RFA) in the treatment of the great saphenous vein. This will be a multicentre randomized clinical trial with a group of over 800 patients.
"We are very excited to start the trial, as we are confident that it will demonstrate once again that ClariVein® is a game changer in the treatment of varicose veins and venous reflux," said John P. Marano, President of Vascular Insights.
"For patients and physicians who demand greater patient comfort and a faster recovery time, this study will be very impactful; we believe the final analysis will prove that ClariVein also represents a more cost effective total solution to venous insufficiency," said Marano.
Dr. Michel Reijnen, principal investigator said, "Varicose veins are a widespread problem and the treatment has evolved to minimal invasive modalities such as laser (EVLA) and radio frequency ablation (RFA). Both thermal modalities, however, are related to pain and complications. The newest modality is Mechanochemical ablation (MOCA™) using the ClariVein® device. Initial results are promising with a low complication rate, less pain and earlier recovery."
Dr. Reijnen added, "The MARADONA trial aims to show that MOCA™ is associated with: 1. Less postoperative pain in the first 14 days; 2. A comparable complication rate; 3. A comparable short and long term occlusion rate compared with RFA. For that purpose, 840 patients will be included in a large randomized trial in the Netherlands."
Data will be collected at 4 weeks, 1 year, 2 years and 5 years as patients are seen on the outpatient clinic to observe the clinical success after treatment objectively.
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.
The investigators anticipate presenting data in early 2013.
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