Rotablator® Rotational Atherectomy System

Prescriptive Information

Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.

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Indications

Percutaneous rotational coronary angioplasty with the Rotablator rotational angioplasty 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 guide wire; Multiple vessel coronary artery disease that in the physician's judgement 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.

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Contraindications

Occlusions through which a guide wire 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. 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.

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Warnings

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; Patient 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 (³45°) lesions; There has been limited experience with the brachial approach. For additional precautions, as well as warnings regarding the operation of the Rotablator system, please see the "Instructions for Use" supplied with the devices.

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Potential Adverse Effects

Access site bleeding of significance, distal embolization, intimal dissection, acute vessel closure, vessel perforation or tear, ventricular perforation, emergency surgery, contrast media reaction, stroke, slow flow, no flow, myocardial infarction, arrhythmia requiring treatment, cardiac tamponade, and death. Prior to use, please see the "Instructions for Use" supplied with these devices.

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Cautions

Federal (USA) law restricts this device to sale by or on the order of a physician.

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Trademark

Dynaglide, RotaLink, Rotablator, RotaWire, and Rotaglide are a trademarks of Boston Scientific Corporation or its affiliates.