The FDA granted Spectranetics 510(k) clearance on Feb. 8 for its bridge occlusion balloon for temporary vessel occlusion in cardiac lead extraction procedures.
Spectranetics said in a news release that it plans on making the balloon immediately available on a limited basis and making it available throughout the U.S. after the Heart Rhythm Society’s annual scientific sessions in San Francisco on May 4 to 7. The device is intended to reduce blood loss during a tear, including in the superior vena cava (SVC), which occurs in fewer than one-half of one percent of lead extraction procedures.
If an SVC tear occurs, the bridge occlusion balloon deploys in less than two minutes, occludes the tear and stems 90 percent of the blood loss for at least 30 minutes, according to Spectranetics.
The company cited data showing there are more than 1.5 million leads implanted each year. Spectranetics’s lead management products include excimer laser sheaths, dilator sheaths, mechanical sheaths and accessories for the removal of pacemaker and defibrillator cardiac leads.