Vascular Insights LLC
ClariVein(R) Announces 800 Patient Randomized Trial
Vascular Insights LLC 01.08.2012 00:00 --------------------------------------------------------------------------- RFA vs. MOCA(TM) for GSV Insufficiency MADISON, Conn., 2012-08-01 00:00 CEST (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(r) in the MOCA(tm) 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(r) 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(tm)) using the ClariVein(r) 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(tm) 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(r) 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. The Vascular Insights LLC logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13814 Joseph Mullally Director of International Sales Vascular Insights LLC j.mullally@vascularinsights.com 203 446 5709 News Source: NASDAQ OMX 01.08.2012 Dissemination of a Corporate News, transmitted by DGAP - a company of EquityStory AG. The issuer is solely responsible for the content of this announcement. DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------------- Language: English Company: Vascular Insights LLC United States Phone: Fax: E-mail: Internet: ISIN: US9901942279 WKN: End of Announcement DGAP News-Service ---------------------------------------------------------------------------
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