Sapheon Inc. announced one year data in its European multicenter
clinical study of the VenaSeal® Sapheon Closure System. VenaSeal is an
advanced approach to the treatment of venous reflux (varicose veins)
disease based on a proprietary medical adhesive and delivery system. The
single-arm, multi-center post-market study involves nine physicians at
seven sites treating 70 patients from the UK, Germany, Demark and The
Netherlands. All patients were treated without tumescent anesthesia or
post-procedure compression stockings, and will be followed for 2 years.
All treatments were successful and a closure rate of 94.3% was observed
at six months. No additional recanalization was observed at one year
According to the study's co-principal investigator, Prof. Dr. Thomas
Proebstle of Mainz University, Germany, "Cyanoacrylate embolization is
proving to be an effective and durable solution to the problem of
incompetent great saphenous veins. Long-term effectiveness is high. The
elimination of the need for perivenous tumescent anesthesia and
post-interventional compression stockigs, along with the associated
side effects, results in significantly improved treatment."
Don Crawford, President and CEO of Sapheon, stated, "We are pleased that
the one year results of the European study are consistent with and
confirmatory of the one year results in our feasibility trial. This
evidence of durability enables us to move forward with the planned 2015
introduction of VenaSeal in the U.S. with the confidence that we have
developed an alternative to thermal ablation that results in greater
VenaSeal is currently under clinical investigation in the United States
in a 1:1 randomized pivotal study (the VeClose Study) to determine its
safety and effectiveness compared to radiofrequency thermal ablation.
The VeClose Study, authorized under an FDA-approved investigational
device exemption (IDE), has clinical investigators at 10 sites in the
U.S. for the treatment of 242 study patients. The study was fully
enrolled in September 2013.
The VenaSeal Sapheon Closure System received CE Mark approval in
September 2011. Since that time, VenaSeal has been used to treat over
1,700 veins in patients in Europe and Hong Kong without tumescent
anesthesia or post-procedure compression hose therapy. At this time, the
VenaSeal Sapheon Closure System is limited to investigational use within
the United States.
Sapheon Inc. is a privately held medical device company whose mission is
to develop new approaches and disruptive technologies for the treatment
of vascular disease. The Company's current focus is on an advanced
treatment for venous reflux disease, a condition requiring over 550,000
surgical procedures worldwide in 2012. The VenaSeal Sapheon Closure
System is not commercially available in the United States. Please visit www.sapheoninc.com
to learn more about Sapheon.
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