Spectranetics Receives FDA 510(k) Clearance for Bridge™ Occlusion Balloon for Lead Extraction Procedures

The Spectranetics Corporation announced U.S. Food and Drug Administration (FDA) Premarket Notification 510(k) clearance of the Bridge Occlusion Balloon for temporary vessel occlusion in cardiac lead extraction procedures. The Bridge Occlusion Balloon builds on the longstanding clinical success and proven procedural safety of cardiac lead extraction. The device is designed to dramatically reduce blood loss in the rare event of a tear, including in the superior vena cava (SVC), providing a “bridge” to surgical intervention.

Clearance of the Bridge Occlusion Balloon initiates a controlled market release with full market launch at the Heart Rhythm Society’s 37^th Annual Scientific Sessions (HRS) in San Francisco, May 4-7, 2016.

“The Bridge Occlusion Balloon represents the biggest breakthrough in lead management in the past 20 years,” said Jude Clancy, MD, Director of the Lead Management Program at Yale Medical Group, New Haven, Conn., and Lead Physician Investigator who will present clinical data on the Bridge Occlusion Balloon at HRS.  “I believe Bridge will have a major impact on the field. It is imperative to have the right tools and techniques to support procedural safety. Bridge empowers extractors to take life-saving action while transitioning to surgical repair, driving positive patient outcomes.”

An SVC tear occurs in less than one half of 1% of lead extraction procedures. When it does, the Bridge Occlusion Balloon is intended to provide temporary occlusion prior to a critical surgical intervention by deploying in under two minutes, occluding the SVC tear and stemming 90% of blood loss for at least 30 minutes.

“The Bridge Occlusion Balloon is a game changer for extractors as well as the cardiac surgeons who support them,” said Roger Carrillo, MD, FHRS, Chief of Surgical Electrophysiology, University of Miami Hospital, Miami, Fla. “With Bridge in place, the surgeon has a clear field of view of the repair site and can quickly take the most appropriate steps for the patient.”

“Spectranetics was founded on a commitment to safe, predictable, responsible, life-saving medical procedures, and Bridge further affirms that commitment,” said Donna Ford-Serbu, Senior Vice President of Sales and Marketing, Lead Management, Spectranetics. “We constantly innovate for safety, through research and development of new tools and techniques and the most comprehensive physician training programs available. Bridge represents another step in Spectranetics’ mission to improve patient care through proactive lead management.”

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.

About Spectranetics

Spectranetics 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.