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. 

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.

Contraindications and Restrictions

Contraindications

1. Occlusions through which a guidewire will not pass.
2. Last remaining vessel with compromised left ventricular function.
3. Saphenous vein grafts.
4. 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.
5. 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.

Restrictions

1. Federal (USA) law restricts the use of this system to physicians who are credentialed in angioplasty and who have attended the Rotablator System Physician Training Program.
2. The minimum requirements (USA) for the primary operator of the Rotablator System in the coronary arteries include:
   • The physician must be accredited and qualified to perform PTCA at his/her llocal institution.
   • The physician must perform a minimum of 75 PTCAs per year as a primary operator.
3. Governing law outside the USA restricts this device to sale by or on the order of a physician.

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.

• If the Rotablator advancer or catheter shows evidence of mechanical failure at any time prior to or during the angioplasty procedure, immediately discontinue use of the device and return it to Customer Service for evaluation. Do NOT attempt to use a damaged Rotablator advancer or RotaLink™ catheter; use may result in device malfunction and/or patient injury.
• Never operate the Rotablator advancer without saline infusion. Flowing saline is essential for cooling and lubricating the working parts of the advancer. Operation of the advancer without proper saline infusion may result in permanent damage to the advancer.
• 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 wireClip torquer may be held with the fingers or inserted completely into the docking port after the brake button is depressed. Defeating the brake, or operating the Rotablator™ advancer in Dynaglide mode, without securing the guidewire may result in rotation and entanglement of the guidewire.
• During setup of the Rotablator System never grip or pull on the flexible shaft.
• 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. Check the advancer for proper connection to the console. If the connections are correct, use fluoroscopy to analyze the situation. Never force the system when rotational or translational resistance occurs, as vessel perforation may occur.
• Never advance the rotating burr by advancing the sheath. Guidewire buckling may occur and perforation or vascular trauma may result. 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. Maintaining the burr in one location while it is rotating may lead to excessive tissue removal or damage to the Rotablator System or entrapment of the Rotablator System. 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 are recommended with total rotational procedure time not to exceed five minutes.

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:
  1. Patients who are not candidates for coronary artery bypass surgery;
  2. Patients with severe, diffuse three-vessel disease (multiple diseased vessels should be treated in separate sessions);
  3. Patients with unprotected left main coronary artery disease;
  4. Patients with ejection fraction less than 30%;
  5. Lesions longer than 25 mm;
  6. 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.
• When the Rotablator guidewires and/or catheters are in the body, they should only be manipulated while they are under fluoroscopic observation with radiographic equipment that provides high resolution images.
• There has been limited experience with the brachial approach.
• Use only normal saline as the infusate. Never inject contrast agent, or any other substance that is not approved as part of the Rotablator System, into the infusion port or saline infusion bag as this may cause permanent damage to the advancer.

Complications

Complications include: 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.

Adverse Events

Potential adverse reactions which may result from the use of this device include but are not limited to:

• Angina or unstable angina
• Arrhythmias
• Bailout stenting
• Cardiac perforation
• Cardiac tamponade
• Conduction block
• Coronary artery spasm
• Death
• 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
• Stroke
• 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.