CVX-300

1. Wilkoff, Bruce L., et al. (May 1999). Pacemaker Lead Extraction with the Laser Sheath: Results of the Pacing Lead Extraction with Excimer Sheath (PLEXES) Trial. Journal of the American College of Cardiology, 33, 6.

2. Byrd, Charles, et al. (May 2002). Clinical Study of the Laser Sheath for Lead Extraction: The Total Experience in the United States. Journal of Pacing and Electrophysiology, 125, 5.

3. Wilkoff, B.L., Love, C.J., Byrd, C.L., Bongiorni, M.G., Carrillo, R.G., Crossley, G.H.,et al. (2009). Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications, and Patient Management.

4. Philips data on file. D014953-10. June 2017.

5. Wazni, O et. al. Lead Extraction in the Contemporary Setting: The LExICon Study: A Multicenter. Observational Retrospective Study of Consecutive Laser Lead Extractions, J Am Coll Cardiol, 55:579-586.

CVX-300 safety information The CVX-300 is an excimer laser system approved for use in minimally invasive interventional procedures within the cardiovascular system and for the removal of problematic pacemaker and defibrillator cardiac leads. Potential adverse events associated with procedures used to treat PAD may include: a sudden, temporary or ongoing re-closure of the treated artery; blood clot or obstruction of the artery by plaque debris; a tear, rupture or damage to the artery (or nearby vein or nerve); minor bleeding or bruising at the entry site. Other complications may occur.

Potential adverse events associated with procedures used to treat coronary artery disease may include: a tear, rupture, damage to the artery; a sudden, temporary or ongoing re-closure of the treated artery; blood clot or obstruction of the artery by plaque debris. Other complications may occur. Potential minor adverse events associated with lead extraction procedures that may or may not require medical or surgical treatment include: a tear or damage to the blood vessels, the heart or its structures; bleeding at the surgical site; or collapsed lung. Rare but serious adverse events that require emergency medical or surgical procedures may include: a tear or damage to the blood vessels, the heart, lungs or their structures; blood clot or obstruction of the blood vessels or lungs by debris or lead fragments. Other serious complications may include: irregular heartbeat, weakened heart muscle, infection, respiratory failure or complications associated with anesthesia, stroke or death. This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

GlideLight safety information Indications for use: The Laser Sheath is intended for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation. Contraindications: Use of the Laser Sheath is contraindicated: When emergency thoracotomy with cardiopulmonary bypass cannot be performed immediately in the event of a life threatening complication; • When fluoroscopy is not available; • In patients in whom superior venous approach cannot be used; • When the proximal end of the pacing lead is not accessible to the operator; • When the lead will not fit into the inner lumen of the Laser Sheath. • Potential Adverse Events

The following adverse events or conditions may also occur during lead extraction with the Laser Sheath, but were not observed during the clinical study (listed in alphabetical order): bacteremia, low cardiac output, migration of lead fragments, migration of vegetation, myocardial avulsion/perforation, premature ventricular contractions, pulmonary embolism, stroke, venous avulsion/perforation, ventricular tachycardia. Risks: No clinical data has been collected using the GlideLight Laser Sheath, which operates using a maximum repetition rate of 80Hz. Therefore, complication rates are reflective of the complication rates observed with the use of the 40Hz Laser Sheath model (SLS). Adverse events observed in clinical studies are: perioperative death, hemopericardium tamponade, hemothorax, death, any complications, pain at cut-down site, arm swelling, infection, SVC thrombosis, tricuspid regurgitation, perforation, phlebitis, and other.

ELCA important safety information Indications: The laser catheters are intended for use either as a stand-alone modality or in conjunction with percutaneous transluminal coronary balloon angioplasty (PTCA) in patients who are acceptable candidates for coronary artery bypass graft (CABG) surgery. The following indications for use, contraindications and warnings have been established through multicenter clinical trials. The Philips CVX-300 Excimer laser system and the multi-fiber laser catheter models are safe and effective for the following indications: occluded saphenous vein bypass grafts, ostial lesions, long lesions (greater than 20mm in length), moderately calcified stenosis, total occlusions traversable by a guidewire, lesions which previously failed balloon angioplasty, restenosis in 316L stainless steel stents, prior to the administration of intravascular brachytherapy. These lesions must be traversable by a guidewire and composed of atherosclerotic plaque and/or calcified material. The lesions should be well defined by angiography. Contraindications: Lesion is in an unprotected left main artery. Lesion is beyond acute bends or is in a location within the coronary anatomy where the catheter cannot traverse. Guidewire cannot be passed through the lesion. Lesion is located within a bifurcation. Patient is not an acceptable candidate for bypass graft surgery.

Potential adverse events: Use of the Philips CVX-300 Excimer laser system may contribute to the following complications: dissection of the arterial wall, perforation, acute reclosure, embolization, aneurysm formation, spasm, coronary artery bypass graft surgery, thrombus, myocardial infarction, arrhythmia, filling defects, death. No long term adverse effects of ELCA are known at this time. Risks: The primary endpoint defined in the laser angioplasty of restenosis stents (LARS) randomized trial was the absence of major adverse cardiac events (MACE) at 6 months: Death; myocardial infarction; coronary artery bypass surgery. Procedural complications include: any dissection, acute thrombus, haziness, no reflow, arrhythmia, acute vessel closure, occlusion of side branch, occlusion non-target, coronary spasm, coronary embolism, coronary perforation, laser/stent damage, balloon/stent damage, and other serious. Caution: Federal law restricts this device to sale by or on the order of a physician

Product availability is subject to country regulatory clearance. Please contact your local sales representative to check the availability in your country.

CVX-300 is distributed by LifeSystems in Australia.

Always read the label and follow the directions for use.

Philips medical devices should only be used by physicians and teams trained in interventional techniques, including training in the use of this device.

Philips reserves the right to change product specifications without prior notification.