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BridgePoint Medical Announced 510(k) Clearance for an Expanded Indication to Treat Coronary Chronic Total Occlusions


5/16/2011 9:55:13 AM

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 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.

SOURCE BridgePoint Medical, Inc.



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