ROTAPRO™ Rotational Atherectomy System

Indications, Safety, and Warnings


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.

INTENDED USE/INDICATIONS FOR USE

Percutaneous rotational coronary atherectomy with the ROTAPRO Rotational Atherectomy System, as a sole therapy or with adjunctive percutaneous coronary intervention (PCI) is indicated in patients with calcific coronary artery disease 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;
  • Patients who have had prior PCI, and who have native coronary artery post-balloon angioplasty restenosis; or,
  • Native vessel atherosclerotic coronary artery disease that is less than 25 mm in length.

CONTRAINDICATIONS AND RESTRICTIONS

Contraindications

  1. Stenoses 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.
  5. Angiographic evidence of significant dissection at the treatment site.

Restrictions

Rotational atherectomy should be performed only by physicians trained in percutaneous interventional procedures.

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 ROTAPRO System without saline infusing.
  • Never operate the ROTAPRO 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 fabric 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 ROTAPRO Advancer stops and the red STALL indicator on the console illuminates, retract the burr and immediately discontinue treatment. Never force the system when rotational or translational resistance is encountered, as guidewire or vessel damage (such as perforation) may occur.
  • Always advance the rotating burr by using the advancer knob.
  • If resistance is encountered, retract the burr and stop treatment immediately. Never force the ROTAPRO™ 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 ROTAPRO for in-stent restenosis might lead to damage of stent components and/or ROTAPRO System, which may lead to patient injury.
  • Do not attempt to treat lesion while the ROTAPRO System is in Dynaglide™ mode. Always keep the burr advancing or retracting while it is rotating. It is best to advance and retract 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. Physicians should be aware of the higher risk when treating patients, such as:

1. Patients who are not candidates for coronary artery bypass surgery;

2. Patients with severe, diffuse three-vessel disease (multiple diseased vessels should be assessed for treatment 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.

  • When performing percutaneous rotational atherectomy with the ROTAPRO System on-site surgical backup should be included as a clinical consideration.
  • Appropriate drug therapy including (but not limited to) anticoagulant/antiplatelet and vasodilator therapy must be provided to the patient during all phases of patient care.
  • A temporary pacemaker may be necessary and is particularly recommended during the treatment of lesions in a dominant right coronary or circumflex artery to resolve profound bradycardia which may occur.
  • Use only normal saline as the infusate.

ADVERSE EVENTS

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

  • Angina
  • Arrhythmias
  • Bailout stenting
  • Conduction block
  • Death
  • Drug reaction, allergic reaction to contrast media
  • Electric shock
  • Embolism (coronary, cerebral, peripheral)
  • Hemorrhage or hematoma
  • Infection, local or systemic
  • Myocardial ischemia
  • Myocardial infarction
  • Pericardial effusion/cardiac tamponade
  • Pulmonary edema/cardiogenic shock
  • Slow flow, no reflow, abrupt vessel closure
  • Stroke
  • Thrombus formation
  • Vessel spasm
  • 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 system, which can lead to patient injury or death. In addition, some of the above potential adverse events may require additional surgical intervention.

 

ROTAWIRE™ Drive Guidewire

Indications, Safety, and Warnings


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.

INTENDED USE/ INDICATIONS FOR USE 

These guidewires are intended for use with the Rotablator™ or ROTAPRO™ Rotational Atherectomy System.

CONTRAINDICATIONS

Carefully read this document and refer to the Rotablator and ROTAPRO System Console “Operator’s Manual”, RotaLink™ Exchangeable Burr Catheter “Instructions for Use”, and ROTAPRO “Instructions for Use” observing all Contraindications, Restrictions, Warnings, and Precautions for specific information on the use of these components.

WARNINGS

The use of a ROTAWIRE Drive Guidewire may straighten a tortuous vessel such that it places the point of burr-vessel interaction on the lesser curvature of the vessel (burr bias) potentially inducing vasospasm and pseudostenoses that may result in perforation and/or dissection during rotational atherectomy treatment. Care needs to be taken to maintain coaxial alignment of the guide catheter and ROTAWIRE Drive Guidewire/burr assembly during ablation. Failure to do so may cause a transected ROTAWIRE Drive 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. Torquing, advancing, or withdrawing guidewire under resistance may cause guidewire and/or vessel damage. Exercise care in handling of the ROTAWIRE Drive Guidewire during the procedure to reduce the possibility of accidental breakage, bending, kinking, coil separation, or loop making in the aorta. A tight loop, kink or sharp bend (greater than 90 degrees in the guidewire) may cause fracture during use. Resulting wire fracture may require additional percutaneous intervention or surgery.

PRECAUTIONS

The guidewire should not be advanced within vessels or stenoses with a narrower diameter than the spring tip to avoid guidewire and vessel damage.

Treating certain types and/or locations of lesions or patients with certain conditions is inherently riskier, regardless of the therapeutic device being used. Physicians should be aware of the higher risk when treating patients, such as:

  1. Patients who are not candidates for coronary artery bypass.
  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.
  7. Patients for whom anticoagulation is not indicated.

This device contains nickel, which may cause allergic reaction in individuals with nickel sensitivity.

ADVERSE EVENTS

Potential adverse reactions which may result from the use of ROTAWIRE™ Drive Guidewires, Rotablator, and ROTAPRO™ Systems 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.

DFU 50694695

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