COLORADO SPRINGS, Colo., Dec. 8, 2015 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (NASDAQ:SPNC) today announced U.S. Food and Drug Administration (FDA) Premarket Notification 510(k) submission of the Bridge Occlusion Balloon. Building on the long-standing clinical success and proven procedural safety of cardiac lead extraction, the Bridge Occlusion Balloon is designed to dramatically reduce blood loss in the rare event of a tear in the superior vena cava (SVC) during a lead extraction procedure, providing a "bridge" to surgical intervention.
The Bridge Occlusion Balloon deploys in less than one minute, conforming to the vessel, stemming blood flow and providing acceptable occlusion for at least 30 minutes. The device is designed to give the physician adequate time to safely transition the patient for surgical repair and to give the surgeon the benefit of a clear field of view for the repair procedure.
"Upon a clearance to enter the U.S. market, the Bridge Occlusion Balloon will be the most significant innovation in lead management since the laser was introduced by Spectranetics 20 years ago," said Jude Clancy, MD, Electrophysiologist, Assistant Professor of Medicine and Director, Lead Management Program at Yale Medical Group, New Haven, Conn. "The device can add the critical element of time to minimally invasive lead removal protocols and help alleviate an extracting physician's primary concern of gaining control during an SVC tear. The device provides physicians a sense of confidence so more indicated patients can have their leads removed safely."
"Spectranetics is committed to safe, predictable and responsible lead management that saves lives and improves quality of life for patients. Our FDA submission advances our commitment to innovation and safety in cardiac lead removal," said Donna Ford-Serbu, Senior Vice President of Sales and Marketing, Lead Management, Spectranetics. "Even though SVC tears during minimally invasive lead removal are rare, occurring in less than 0.5% of procedures, we aim for zero mortalities."
About Lead Management
There are more than 7 million pacemakers and implantable cardiac defibrillators (ICDs) implanted worldwide, 700,000 new devices implanted each year and 1.5 million new leads implanted annually. These devices and the leads that connect them to the heart need ongoing management and maintenance. Sometimes this includes removal due to lead damage, lead or device infection, or manufacturer advisory. Laser lead extraction has been a treatment option for more than 20 years. Multiple studies show a procedural success rate of more than 97% demonstrating safety, effectiveness and efficiency of laser lead removal. In 2014, Spectranetics introduced mechanical tools into its comprehensive portfolio of lead management solutions.
SPNC develops, manufactures, markets and distributes medical devices used in minimally invasive procedures within the cardiovascular system. The Company's products are sold in over 65 countries and are used to treat arterial blockages in the heart and legs and in the removal of pacemaker and defibrillator leads.
The Company's Vascular Intervention (VI) products include a range of laser catheters for ablation of blockages in arteries above and below the knee, the AngioSculpt® scoring balloon used in both peripheral and coronary procedures and Stellarex™ drug-coated balloon peripheral angioplasty platform, which received European CE mark approval in December 2014. The Company also markets support catheters to facilitate crossing of peripheral and coronary arterial blockages, and retrograde access and guidewire retrieval devices used in the treatment of peripheral arterial blockages, including chronic total occlusions. The Company markets aspiration and cardiac laser catheters to treat blockages in the heart.
The Lead Management product line includes excimer laser sheaths, dilator sheaths, mechanical sheaths and accessories for the removal of pacemaker and defibrillator cardiac leads.
For more information, visit www.spectranetics.com.
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