The number of implanted leads has grown dramatically with the growth of implanted cardiac systems. In about 5% of cases the leads of implanted pacemakers and defibrillators become nonfunctional or infected and, in many cases, must be removed. In 2010 there were approximately 5 million installed leads in the U.S. alone, about half of which were installed during the past five years. Industry experts forecast that the LE market will grow at about 15% per year, in part because laser-based tools are making the procedure faster and safer, and in part because it is anticipated that regulators will continue to issue recalls of implanted cardiac devices from time to time.
Currently attempts are made to remove problematic leads in only about 50% of the cases, largely due to inadequate extraction tools. Dedicated tools have been developed for performing these procedures and are commercially available. However, each such tool has its own set of drawbacks related to efficacy, efficiency, cost, and in some cases, safety.
Eximo's proprietary, single-use catheter, B-Laser™ combines laser and mechanics allowing precise and safe material removal.