CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.
Rotablator Rotalink Plus/Rotawire/Console INTENDED USE/INDICATIONS FOR USE:
Percutaneous rotational coronary angioplasty with the Rotablator Rotational Atherectomy System, as a sole therapy or with adjunctive balloon angioplasty, is indicated in patients with coronary artery disease who are acceptable candidates for coronary artery bypass graft surgery and who meet one of the following selection criteria:
- Single vessel atherosclerotic coronary artery disease with a stenosis that can be passed with a guidewire;
- Multiple vessel coronary artery disease that in the physician’s judgment does not pose undue risk to the patient;
- Certain patients who have had prior percutaneous transluminal coronary angioplasty (PTCA), and who have a restenosis of the native vessel; or,
- Native vessel atherosclerotic coronary artery disease that is less than 25 mm in length.
Rotablator Rotaglide INTENDED USE/INDICATIONS FOR USE:
Rotaglide lubricant is intended for use with the Rotablator atherectomy system, for the purpose of increasing the lubricity of the system.
Rotablator Rotalink Plus/Rotawire/Console CONTRAINDICATIONS
- Occlusions through which a guidewire will not pass.
- Last remaining vessel with compromised left ventricular function.
- Saphenous vein grafts.
- Angiographic evidence of thrombus prior to treatment with the Rotablator System. Such patients may be treated with thrombolytics (e.g., Urokinase). When the thrombus has been resolved for two to four weeks, the lesion may be treated with the Rotablator System.
- Angiographic evidence of significant dissection at the treatment site. The patient may be treated conservatively for approximately four weeks to permit the dissection to heal before treating the lesion with the Rotablator System.
Rotablator Rotaglide CONTRAINDICATIONS:
Rotaglide lubricant is contraindicated in patients with known allergies to the lubricant ingredients: olive oil, egg yolk phospholipids, glycerin, sodium deoxycholate, L-histidine, disodium EDTA, sodium hydroxide, and water.
Rotablator Rotalink Plus WARNINGS
- The risks of Rotational Atherectomy can be reduced if the device and associated accessories are used in the appropriate patient population by a physician who has had adequate training.
- Never operate the Rotablator advancer without saline infusion.
- Never operate the Rotablator advancer in Dynaglide mode or operate the guidewire brake defeat button unless you have a firm grip on the guidewire using the wireClip torquer.
- The burr at the distal tip of the RotaLink catheter is capable of rotating at very high speeds. Do NOT allow parts of the body or clothing to come in contact with the burr. Contact may result in physical injury or entanglement.
- Never advance the rotating burr to the point of contact with the guidewire spring tip. Such contact could result in distal detachment and embolization of the tip.
- If the Rotablator advancer stops and the red STALL light on the console illuminates, retract the burr and immediately discontinue treatment. Never force the system when rotational or translational resistance occurs, as vessel perforation may occur.
- Always advance the rotating burr by using the advancer knob.
- If resistance is encountered, retract the burr and stop treatment immediately. Use fluoroscopy to analyze the situation. Never force the Rotablator advancer when rotational or translational resistance occurs, as vessel perforation, vessel trauma or embolism due to burr detachment or fractured wire may occur and in rare instances may result in surgical intervention and death.
- The use of Rotablator for in-stent restenosis might lead to damage of stent components and/or Rotablator System, which may lead to patient injury.
- Always keep the burr advancing or retracting while it is rotating. It is best to advance and retreat the burr no more than 3 cm at a time in a smooth pecking motion, being careful to engage the lesion only minimally when resistance is met. Short individual runs of less than 30 seconds
Rotablator Rotawire WARNINGS
- Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated.
- Exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking, or coil separation. Resulting guidewire fractures might require additional percutaneous intervention or surgery.
- Do not allow the individual burr run time to exceed 30 seconds as this may lead to wire fracture/tip separation that may result in perforation, dissection, embolism, myocardial infarction and in rare cases, death.
- Care needs to be taken to maintain coaxial alignment of the guide catheter and RotaWire Guidewire/burr assembly during ablation. Failure to do so may cause a transected RotaWire Guidewire that may result in embolism, myocardial infarction, dissection, and /or surgical intervention and in rare cases, death.
- Do not torque, advance or withdraw guidewire if significant resistance is felt. Exercise care in handling of the RotaWire Guidewire during the procedure to reduce the possibility of accidental breakage, bending, kinking or loop making in the aorta. Resulting wire fracture may require additional percutaneous intervention or surgery.
- Never operate the guidewire brake release unless you have a firm grip on the guidewire using the wireClip™ Torquer.
- Do not allow the burr to remain in one location while rotating at high speeds. Ensure that the free lumen rotational speed of the burr does not exceed 180,000 rpm for 1.25 mm to 2.0 mm burrs and 160,000 rpm for the 2.15 mm and larger burr sizes.
Rotablator Console WARNINGS:
- Never use oxygen as the propellant for the Rotablator Rotational Atherectomy System. Never connect the regulator to an oxygen cylinder. Oxygen combined with oil or other combustibles in the system can result in an explosion.
- The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the Rotablator System as replacement parts for internal components, may result in increased emissions or decreased immunity of the Rotablator System.
- This device is not to be used in the presence of flammable anesthetics.
- Do NOT operate the Rotablator Console with gas pressures in excess of 758.4 kPa (110 psi), as a compressed gas hose may burst.
- Do not modify or repair. Modification or repair of the instrument by a person other than an authorized Boston Scientific representative may compromise the integrity of the device and/or lead to device failure which, in turn, may result in patient injury or death.
Rotablator Rotaglide WARNINGS:
- Discard vial of Rotaglide lubricant if there are particulates in the emulsion or if an oiling-out (separation) of emulsion has occurred (identified by yellowish streaking or the accumulation of yellowish droplets).
Rotablator Rotalink Plus PRECAUTIONS:
- Treating certain types and/or locations of lesions or patients with certain conditions is inherently riskier, regardless of the therapeutic device being used. For many of these applications, relatively few cases have been carried out using the Rotablator System. Physicians should be aware of the higher risk when treating such patients and the lack of scientific evidence for treatment in the following applications:
- Patients who are not candidates for coronary artery bypass surgery;
- Patients with severe, diffuse three-vessel disease (multiple diseased vessels should be treated in separate sessions);
- Patients with unprotected left main coronary artery disease;
- Patients with ejection fraction less than 30%;
- Lesions longer than 25 mm;
- Angulated (≥ 45°) lesions.
- Percutaneous rotational angioplasty with the Rotablator System should only be carried out at hospitals where emergency bypass surgery can be immediately performed in the event of a potentially injurious or lifethreatening complication.
- Appropriate drug therapy including (but not limited to) anticoagulant and vasodilator therapy must be provided to the patient during all phases of patient care.
- A temporary pacing lead may be necessary and is particularly recommended during the treatment of lesions in the right coronary and dominant circumflex arteries to resolve electrophysiological aberrations which may occur.
- There has been limited experience with the brachial approach.
- Use only normal saline as the infusate.
Rotablator Rotawire PRECAUTIONS:
- The 0.009 in (0.24 mm) RotaWire Guidewire is smaller in diameter than other commercially available guidewires used in coronary angioplasty. Therefore, handle the guidewire carefully to prevent a tight loop, kink, or sharp bend (> 90°) from forming in the guidewire, which may cause it to fracture during use. Resulting wire fracture may require additional percutaneous intervention or surgery.
- If patient defibrillation is necessary, the burr will be pulled back from the treatment area while the guidewire stays in position. Before starting defibrillation, be sure that the guidewire is sufficiently insulated from the ground.
Rotablator Console WARNINGS:
- User should take precautions when using the Rotablator Console in conjunction with other medical electrical equipment.
- The Rotablator Console needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in Appendix D in the DFU.
Rotablator Rotaglide WARNINGS:
- When using Rotaglide lubricant, careful consideration should be given to additions of divalent cations (Ca++ and Mg++) which have been shown to cause emulsion instability.
System ADVERSE EVENTS
Potential adverse reactions which may result from the use of this device include but are not limited to:
- Angina or unstable angina
- Bailout stenting
- Cardiac perforation
- Cardiac tamponade
- Conduction block
- Coronary artery spasm
- Drug reaction, allergic reaction to contrast media
- Embolism (coronary, cerebral, peripheral)
- Hemorrhage or hematoma
- Infection, local infection, systemic infection
- Myocardial ischemia
- Myocardial infarction (Q-wave and non Q-Wave)
- Pericardial effusion
- Pulmonary edema/cardiogenic shock
- Slow flow, no flow, abrupt vessel closure
- Vascular thrombus
- Vessel trauma (dissection, perforation, rupture or injury)
There may also be complications associated with distortion, kinks, and fracture of the guidewire and physical deterioration or malfunction of the device, which can lead to patient injury or death.