BridgePoint Medical Announced 510(k) Clearance for an Expanded Indication to Treat Coronary Chronic Total OcclusionsBy Bridgepoint Medical Inc., PRNE
Sunday, May 15, 2011
MINNEAPOLIS, May 16, 2011 - BridgePoint Medical, Inc., a Minnesota-based medical device company, has
announced that they have received clearance of an expanded indication for the
CrossBoss(TM) Catheter and Stingray(TM) 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
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(TM) Catheter and
Stingray(TM) System will be greatly expanded with this new level of
indication. BridgePoint is the first interventional device company to be
granted this specific type of approval for both crossing and re-entry
technologies to be used in the treatment of coronary CTOs.
Company CEO and President Denis Harrington says, "We are excited about
the expanded indication. The FAST-CTO Trial demonstrated the safety and
effectiveness of the CrossBoss Catheter and Stingray System in treating these
most challenging lesions - CTOs. And we are poised to be the leader in
helping physicians treat these patients."
About BridgePoint Medical:
BridgePoint Medical, Inc. is a privately held company established in 2006
to design, develop and commercialize new technologies and techniques to treat
challenging coronary and peripheral artery disease. Investors include New
Enterprise Associates, Polaris Venture Partners, Foundation Medical Partners
and Michael Berman.
Denis Harrington, President and CEO of BridgePoint Medical, +1-763-225-8500
Tags: Bridgepoint Medical Inc., May 16, Minneapolis, Minnesota