HeartLight System animation highlighting titratable laser energy, direct tissue visualization and compliant balloon technology in atypical left atrial anatomy. ©2017 CardioFocus.
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of physician. The HeartLight® Endoscopic Ablation System is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation.
Contraindications: The HeartLight System should not be used:
1.In patients who have had a ventriculotomy or atriotomy within the preceding four weeks as the recent surgery may increase the risk of perforation;
2.In patients with prosthetic valves as the catheter may damage the prosthesis;
3.In patients with an active systemic infection as this may increase the risk for cardiac infection;
4.In patients with unstable angina;
5.In patients with an interatrial baffle or patch because the opening could persist and produce an iatrogenic atrial shunt following transseptal puncture;
6.In the ventricle because of the danger of catheter entrapment in the chordae tendineae;
7.In patients with conditions where the manipulation of the catheter within the heart would be unsafe (for example, presence of intracardiac thrombus and myxoma);
8.In patients with one or more pulmonary vein stents
Only adequately trained personnel in a fully equipped electrophysiology laboratory should perform cardiac ablation procedures. This device should be used only by physicians fully trained in cardiac electrophysiology procedures. Prospective physician operators of the HeartLight Endoscopic Ablation System must complete specific training provided by CardioFocus prior to the first clinical procedure.
Operation Manual / Instructions for Use – Do not attempt to use the HeartLight System before reading and completely understanding the HeartLight Endoscopic Ablation System Operation and Maintenance Manual.