Sapheon Inc. announced today that it submitted the first module of the
pre-market approval (PMA) application for the VenaSeal® Sapheon Closure
System to the U.S. Food and Drug Administration (FDA). The submission
places Sapheon on track for timely FDA review and expected product
launch in the first half of 2015. VenaSeal is a minimally invasive,
single use kit intended for the treatment of venous reflux (varicose
veins) disease. The device is currently under clinical investigation in
a 1:1 randomized pivotal study (the VeClose Study) to determine its
safety and effectiveness compared to radio frequency thermal ablation.
"VenaSeal represents a novel approach to the treatment of venous reflux
disease," said Monte Madsen, Vice President, Clinical Affairs for
Sapheon. "It is designed to eliminate the need for tumescent anesthesia
by using our proprietary medical adhesive to close the great saphenous
vein instead of heat to burn and destroy the vein."
The VeClose Study is authorized under an investigational device
exemption (IDE) approved by the FDA in December 2012. Clinical
investigators at 10 sites in the U.S. have treated 242 patients in the
study. In addition to the VeClose Study, Sapheon is sponsoring two other
VenaSeal studies: a 70-patient European post-market evaluation at seven
sites within Germany, the UK, The Netherlands and Denmark that completed
enrollment in September 2012; and a 38-patient feasibility study
conducted in the Dominican Republic that completed enrollment in July
2011. The clinical data collected in these studies will be used to
support the PMA application as well as to support product reimbursement
activities in markets outside the United States.
The VenaSeal Sapheon Closure System received CE Mark approval in
September 2011. Since that time, VenaSeal has been used to treat over
1,000 veins in patients in Europe and Hong Kong without tumescent
anesthesia or the need for post-procedure compression hose therapy.
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. VenaSeal® uses a proprietary
medical adhesive to close the saphenous vein, eliminating the need for
surgery, ablation, sedatives, anesthesia, and the use of harsh
chemicals. The VenaSeal Sapheon Closure System is not commercially
available in the United States. Please visit www.sapheoninc.com
to learn more about Sapheon.
Harry Phillips, 919-948-3987