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