ClariVein(R) Announces 800 Patient Randomized Trial

7/31/2012 6:00 PM EST

Vascular Insights LLC
Press release

ClariVein(R) Announces 800 Patient Randomized Trial

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® 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.

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
          
         203 446 5709