MINNEAPOLIS, Aug. 3, 2011 /PRNewswire/ — BridgePoint Medical,
Inc., a Minnesota-based medical device company, has announced that
they have enrolled their first patient in the Peripheral
Facilitated Antegrade Steering
Technique in Chronic Total Occlusions
(PFAST-CTOs) study. The company received approval from the
FDA in July, 2011 to move forward with the US based IDE for the
peripheral devices and is now actively enrolling patients.
The 10 center, 100 patient U.S. PFAST-CTOs study is designed
to assess the safety and effectiveness of the BridgePoint devices
in chronically occluded arteries located in the lower
extremities.
Dr. Subhash Banerjee of the VA North Texas Health Care System
and UT Southwestern Medical Center, the first physician to enroll a
patient in the PFAST-CTOs study, stated, “Predicated by the success
of the BridgePoint coronary CTO system, we are very optimistic
about the Peripheral device’s performance possibilities and we are
looking forward to a robust and successful study.”
The BridgePoint peripheral products are similar to the coronary
system in concept, but have been specifically designed and adapted
for use in peripheral vasculature and will expand the company’s
reach into the fast growing peripheral market.
Company CEO and President Denis Harrington reflected, “This is a
very important milestone for BridgePoint Medical. With the IDE
approval and the first case enrolled, we are now officially started
in our quest to build a strong Peripheral CTO franchise to
complement our market leading Coronary CTO franchise.”
About Peripheral Artery Disease and Chronic Total
Occlusions:
Atherosclerotic peripheral artery disease (PAD) is a widely
prevalent disorder that affects millions world-wide and is
associated with significant morbidity and mortality. A CTO,
which represents a complete artery blockage, typically
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