MINNEAPOLIS, May 16, 2011 /PRNewswire/ — BridgePoint Medical,
Inc., a Minnesota-based medical device company, has announced that
they have received clearance of an expanded indication for the
CrossBoss™ Catheter and Stingray™ System from the FDA.
The expanded indication includes the intraluminal placement
of conventional guidewires beyond stenotic coronary lesions
[including chronic total occlusions (CTOs)] prior to PTCA or stent
intervention. CTOs are chronically stenosed lesions that
completely block a coronary artery – typically for 3 months
or longer – and prevent blood circulation to critical areas of the
heart.
Company Founder & COO Chad Kugler reflected, “This is the
culmination of 5 years of development, clinical and regulatory
work. We are grateful for the opportunity to market these
products for the specific challenge they were developed for and
confident that we have created a great solution for treating
CTOs.”
This expanded indication is the result of data generated from
the 147-patient FAST-CTOs clinical trial in which the safety and
effectiveness of the system in coronary chronic total occlusions
was demonstrated.
Dr. William Lombardi of St. Joseph’s Hospital in Bellingham, WA
and a leading enroller in the clinical trial states, “The
BridgePoint system is the first set of devices designed
specifically for treating coronary Chronic Total Occlusions that
has shown real improvements in safety, procedural efficiency, and
clinical success rates. The clinical trial has proven that
these arteries can be opened effectively with these products and
now with the expanded indication from the FDA there will be a new
level of awareness among physicians and patients.”
BridgePoint’s ability to commercialize its CrossBoss™
Catheter and Stingray™ System will be greatly expanded with
this new level of indication. BridgePoint is the first
interventional device company t
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