MINNEAPOLIS, Nov. 23 /PRNewswire/ -- BridgePoint Medical announced today that it received European CE Mark (Conformite Europeene) for its coronary and peripheral Chronic Total Occlusion (CTO) Crossing System comprised of the CrossBoss(TM) CTO Crossing Catheter and the Stingray® CTO Re-Entry System. The BridgePoint System is a series of interventional catheters that are designed to navigate highly diseased arteries in preparation for blood flow restoration via angioplasty and stenting.
The National Heart, Lung and Blood Institute (NHLBI) estimates that Chronic Total Occlusions (CTOs) are common and are found in approximately one-third of patients who undergo angiography, which equates to a world wide annual incidence of 1.3 million patients. Interventional cardiologists are currently unable to broadly treat patients with chronic total occlusions due to the procedurally challenging and advanced nature of the disease. For these patients, alternatives include bypass surgery or pharmacologic therapy. For the millions of people with living with a coronary CTO, chest pain, shortness of breath and fatigue are part of every day life.
"We have seen many attempts to implement new tools for the treatment of chronic coronary occlusions over the years, but until now none of them have provided any advantage over the current treatment of using specialty guidewires," said Gerald Werner M.D. Ph.D., Professor at the Klinikum Darmstadt in Darmstadt, Germany. "This system is the first to provide a new option for the frequent situation when our guidewires do not reach the vessel beyond the occlusion. The BridgePoint system makes it possible to find the true vessel lumen and conclude the treatment successfully."
The disposable BridgePoint Catheter System does not require the use of expensive and cumbersome capital equipment and uses techniques that are common in interventional medicine.
"The CrossBoss and Stingray devices provide interventionalists in the E.U. with new opportunities to treat patients with highly diseased arteries. We believe that these devices represent an important new advance in interventional cardiology," said Chad Kugler, Co-Founder, President and General Manager, BridgePoint Medical. "This technology exemplifies BridgePoint's innovative approach to CTO treatment and our commitment to further reduce the need for invasive bypass surgery."
The BridgePoint Medical CrossBoss and Stingray are indicated in the European Union for adults with coronary or peripheral artery disease, age 18 and older. The devices are contraindicated for use in cerebral vasculature.
Clinical Trial Summary
In a prospective clinical trial conducted in the European Union and a post-market registry conducted primarily in South America the BridgePoint System was 67%-85% successful in placing an interventional guidewire beyond a chronic total coronary occlusion. Complications with the system were similar to general PCI and stenting.
The BridgePoint devices are currently under clinical investigation in the U.S. and are not commercially available for treating CTO in the U.S.
About Chronic Total Coronary Occlusions
The National Heart, Lung and Blood Institute (NHLBI) estimates that Chronic Total Occlusions (CTOs) are common and are found in approximately one-third of patients who undergo angiography. Patients surviving with a CTO commonly suffer from poor blood circulation to the heart muscle that induces symptoms such as chest pain (angina), shortness of breath and fatigue. Studies also show that the patients living with an untreated coronary CTO are at higher risk of death.
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 artery disease. Investors include New Enterprise Associates, Polaris Venture Partners, Foundation Medical Partners and Michael Berman.
SOURCE BridgePoint Medical, Inc.
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