CardioFocus® HeartLight® Endoscopic Ablation System
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:
- In patients who have had a ventriculotomy or atriotomy within the preceding four weeks as the recent surgery may increase the risk of perforation;
- In patients with prosthetic valves as the catheter may damage the prosthesis;
- In patients with an active systemic infection as this may increase the risk for cardiac infection;
- In patients with unstable angina;
- In patients with an interatrial baffle or patch because the opening could persist and produce an iatrogenic atrial shunt following transseptal puncture;
- In the ventricle because of the danger of catheter entrapment in the chordae tendineae;
- In patients with conditions where the manipulation of the catheter within the heart would be unsafe (for example, presence of intracardiac thrombus and myxoma);
- 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.
Adverse reaction to anesthesia, air embolism, anemia, anxiety, aspiration pneumonia, atrio-esophageal fistula, esophageal ulceration, esophageal tear, arteriovenous (AV) fistula, back pain, bleeding from puncture site, blood clot/thromboembolic event/deep vein thrombosis, blurred vision or vision changes, bradycardia, bronchitis, bruise, cardiac perforation/tamponade/tear, cardiopulmonary arrest, chest pain/ discomfort/pressure, complete heart block, coronary artery spasm, dissection thrombosis, cough, death, diarrhea, dizziness/vertigo, dysphagia, esophago-mediastinal fistula, fatigue, fever, headache, hematoma, hemothorax, hemorrhage, hemoptysis, hypertension/ hypotension, incision site pain/tenderness, infection, major bleeding, myocardial infarction, nausea/vomiting, nerve injury, neurological deficits, pain or severe coughing during energy delivery, pericardial effusion, pericarditis, phrenic nerve damage leading to diaphragmatic paralysis, phrenic nerve palsy, pneumothorax, pleural effusion, pseudo-aneurysms, pulmonary edema, pulmonary vein stenosis/ occlusion, pyrogenic reaction, scarring, sepsis, shortness of breath, stroke / transient ischemic attack (TIA) / cerebrovascular accident, tachyarrhythmia, ulceration, urinary infection, wound healing difficulties, valvular damage, vascular complication requiring surgery, vascular damage / tear, vasovagal reactions
Refer to the device operating manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events and other important information. For further information, please call CardioFocus at 844-527-3723.
Federal Law (USA) restricts this device to sale by or on the order of a physician.
500 Nickerson Road
Marlborough, MA 01752