Philips Laser System — Nexcimer
Laser system for coronary and peripheral atherectomy and lead management
Philips Laser System — Nexcimer
Laser system for coronary and peripheral atherectomy and lead management
Philips Laser System —Nexcimer— photoablates a wide spectrum of morphologies. Philips laser catheters are indicated in many vessel types and is the only laser system available for lead removal. Powered by a common 100-240V electrical outlet, the system warms up in less than 30 seconds for an easy and fast set-up.
Features
Indicated treatments
Philips Laser System — Nexcimer—supports catheters with coronary vascular, peripheral vascular and lead management indications.
Proven excimer technology
Cool, ultraviolet laser with over 20 years of clinical experience. More than 600,000 procedures performed with excimer laser.¹ Only system compatible with catheters with Level I clinical data for ISR laser atherectomy.²
Versatile: more vessels, more indications
For use in any lab, on any floor. The system supports seven coronary indications, is the only device proven for peripheral ISR², and is the only laser system available for lead management. Puts the control in physician's hands to adjust both fluence and rates for individualized treatment for each patient.
Specifications
- System specifications
- Active medium
- XeCl
- Weight
- 480 lbs / 217 kg
- Wavelength
- 308 nm
- Length
- 52 in / 132 cm
- Catheter output fluence
- 30-80 mJ/mm2
- Height
- 42 in / 107 cm
- Repetition rate
- 25-80 Hz
- Width
- 19 in / 48 cm
- Pulse width
- 125-200 ns, FWHM
- Power requirements
- 100 – 240 VAC (single phase), 50/60 Hz, 16 amp
- Product number
- LAS-100
Related products
- The Turbo-Power laser atherectomy catheter debulks the lesion in a single step and offers remote automatic rotation for precise directional control. Turbo-Power is the only atherectomy device proven and approved for the treat of ISR.
- Safely and efficiently removing leads depends on tools that give you versatility and control. GlideLight laser sheath offers the unprecedented ability to customize the laser’s repetition rate throughout a procedure. At 80Hz, the GlideLight laser sheath requires up to 55% less advancement force,¹ and advance up to 62% more efficiently through tough binding sites than SLS II.²
- Turbo-Elite laser atherectomy catheter captures the power of ultraviolet light to provide a versatile and reliable tool for treating multiple lesion morphologies within PAD lesions. Utilizing laser's unique mechanism of action, Turbo-Elite is capable of powering through the most challenging restenoses and occlusions.
- ELCA coronary laser atherectomy catheters are designed to cross, prepare and treat the most complex coronary lesions. This non-mechanical atherectomy catheter can be delivered over any .014” wire and can de-bulk and modify plaque of multiple morphologies and is approved for the broadest range of coronary indications in atherectomy.
Disclaimer
1. Internal Sales data on file.
2. Dippel et al. Randomized Controlled Study of Excimer Laser Atherectomy for Treatment of Femoropopliteal In-stent Restenosis: Initial ISR Results (2015). JACC 8(1): 92-101.
Product availability is subject to country regulatory clearance. Please contact your local sales representative to check the availability in your country.
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 Laser System Important Safety Information
The Philips Laser system is used in minimally invasive interventional procedures within the cardiovascular system and for the removal of problematic pacemaker and defibrillator cardiac leads. The Philips Laser System produces pulsed excimer radiation, which is delivered to the target site with proprietary fiber optic catheter technology, or other approved instruments or accessories, to complete the system.
For information on indications, contraindications, adverse events, and other important safety information, refer to the individual instructions for use that accompanies the Philips fiber-optic catheters.
Important
Read the Operator's Manual thoroughly before operating the system. Pay particular attention to the notes, cautions, and warnings throughout the manual to ensure safe operating conditions at all times. Also, refer to the Instructions for Use that accompanies the Philips fiber-optic catheters. Indications and contraindications are included in the individual instructions for use for the catheters.
Warnings
• The Philips Laser System contains a Class IV laser that produces an invisible beam of high-energy ultraviolet radiation. Improper use of the system could result in serious personal injury. Observe all safety precautions for use of Class IV laser equipment.
• The system contains high voltages, which are potentially lethal. To avoid electrical shock, do not open the system cabinet. external maintenance must be performed solely by a certified field service engineer.
• The system is not intended to be used during a defibrillation event.
• Skin exposure to excimer radiation should be avoided
• Possible explosion hazard if used in the presence of flammable anesthetics.
Notice
• The system is intended for use only by licensed physicians. All persons who operate and service the system must be properly trained.
• The system contains a gas mixture that is 0.05% HCl, a respiratory irritant. To avoid injury, only a trained and certified field service engineer should handle the laser gas.
Safety Precautions
• The laser system must be operated only by trained personnel.
• Always wear safety glasses with an Optical Density ≥9 @ 308nM for eye protection against laser radiation.
• Establish a controlled-access laser operating area to limit access to persons Instructed in the safe operation of lasers.
• Post "Laser in operation" warning signs at all entries to the laser operating area.
• Persons in the laser operating area including doctors, nurses, observers and the patient must wear the appropriate protective eyewear and protective gloves.
• Never look directly into the laser beam.
• Avoid uncontrolled reflections of the laser beam.
• Skin exposure to excimer laser radiation should be avoided.
• Do not allow direct or reflected laser radiation to go beyond the laser operating area.
• When not in use, the laser system should be protected against unauthorized use by removing the key.
• Special precautions are required regarding the Electromagnetic Compatibility (EMC) of the Philips Laser System. Refer to the user manual for details.
• Caution: Federal law restricts this device to sale by or on the order of a physician.
ELCA Important Safety Information
The Laser Catheters used in conjunction with the Philips CVX-300 Excimer Laser System are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery. Adjunctive balloon angioplasty was performed, at the clinical investigator’s discretion, for 85% of the lesions treated. The following Indications for Use, Contraindications and Warnings have been established through multicenter clinical trials. Clinical experience has provided reasonable assurance that the Philips CVX-300 Excimer Laser System and the multifiber 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 stenoses (Heavily calcified stenoses are those lesions that demonstrate complete calcification when identified under fluoroscopy by angiography prior to the procedure. Moderately and slightly calcified stenoses are all others.)
• Total occlusions traversable by a guidewire
• Lesions which previously failed balloon angioplasty (This includes those lesions that were treated unsuccessfully by PTCA. Lesions that have undergone a complicated PTCA procedure are not included in this category.)
• Restenosis in 316L stainless steel stents, prior to the administration of intravascular brachytherapy. (not indicated for X-80 models)
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
Contraindictations
• 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
• Patient has acute thrombosis (applicable to X-80 models only)
• Patient has experienced an acute myocardial infarction (applicable to X-80 models only)
• Patient has ejection fraction of less than 30% (applicable to X-80 models only) See complete IFU for more information before attempting use of ELCA.
Potential adverse events
• Use of ELCA 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.
GlideLight Important 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.
Caution: Federal law restricts this device to sale by or on the order of a physician.