ClariVein(R) Dose Finding Trial
8/31/2012 3:00 AM EST
Vascular Insights LLC
Press release
ClariVein(R) Dose Finding Trial
MADISON, Conn., 2012-08-31 09:00 CEST (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.
The Vascular Insights LLC logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=13814
CONTACT: Joseph Mullally
Director of International Sales
Vascular Insights LLC
203 446 5709