ROTAPRO™ Rotational Atherectomy System

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential 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

• Stenoses through which a guidewire will not pass.
• Last remaining vessel with compromised left ventricular function.
• Saphenous vein grafts.
• Angiographic evidence of thrombus.
• Angiographic evidence of significant dissection at the treatment site.

Restrictions

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

WARNINGS

• If the ROTAPRO Advancer or RotaLink Catheter shows evidence of mechanical failure at any time prior to or during the atherectomy procedure, immediately discontinue use of the device and return it to Customer Service for evaluation. Do NOT attempt to use a damaged ROTAPRO Advancer or RotaLink Catheter; use may result in device malfunction and/or patient injury.
• Never operate the ROTAPRO System without saline infusing. Flowing saline is essential for cooling and lubricating the working parts of the advancer. Operating the advancer without proper saline infusion may result in permanent damage to the ROTAPRO Advancer.
• 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 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 ROTAPRO Advancer in Dynaglide mode, without securing the guidewire may result in rotation and entanglement of the guidewire.
• During setup of the ROTAPRO System never grip or pull on the flexible shaft.
• 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. 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 is encountered, as guidewire or vessel damage (such as 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 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. Maintaining the burr in one location while it is rotating may lead to excessive tissue removal or entrapment to the ROTAPRO System. 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.

POTENTIAL 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.

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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

The wireClip Torquer is an accessory component shipped with the guidewire and is also available separately. It is used for gripping and rotating the guidewire during placement. It must be used during the ablation procedure.

CONTRAINDICATIONS

Refer to the Rotablator System Rotalink Exchangeable Burr Catheter “Instructions for use” before using the wireClip Torquer during a Rotablator System rotational atherectomy procedure.

WARNINGS

Refer to the Rotablator System Rotalink Exchangeable Burr Catheter “Instructions for use” before using the wireClip Torquer during a Rotablator System rotational atherectomy procedure

PRECAUTIONS

Refer to the Rotablator™ System Rotalink™ Exchangeable Burr Catheter “Instructions for use” before using the wireClip™ Torquer during a Rotablator System rotational atherectomy procedure.

ADVERSE EVENTS

Refer to the Rotablator System Rotalink Exchangeable Burr Catheter “Instructions for use” before using the wireClip Torquer during a Rotablator System rotational atherectomy procedure.

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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.

INDICATIONS FOR USE

Rotaglide lubricant is intended for use with the Rotablator or ROTAPRO atherectomy system, for the purpose ofincreasing the lubricity of the system. The Indications for Use of the Rotablator or ROTAPRO system remain unchanged.

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.

WARNINGS

Always check the vial for cracks or leaks. Discard if any are found. Discard vial if there are particulates in the emulsion or if an oiling-out of emulsion has occurred.

PRECAUTIONS

Careful consideration should be given to additions of divalent cations (Ca++ and Mg++) which have been shown to cause emulsion instability.

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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. The distal spring tip is designed to not pass through the lumen of the burr catheter. The ROTAWIRE Drive cannot be withdrawn through the advancer. The advancer must be removed prior to ROTAWIRE Drive exchange.

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.

When performing percutaneous rotational atherectomy with the ROTAPRO System on-site surgical backup should be included as a clinical consideration.

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:

• Additional intervention or surgery
• Allergic reaction (contrast, device or other)
• Angina
• Arrhythmia
• Cerebral vascular accident/Transient ischemic attack
• Death
• Electric shock
• Embolism (air, device, plaque, thrombus, tissue, or other)
• Hemorrhage or hematoma
• Hypotension/hypertension (including cardiogenic shock)
• Infection/sepsis
• Myocardial ischemia or infarction
• Pericardial effusion /cardiac tamponade
• Pulmonary edema
• Vessel occlusion (slow flow, no reflow, abrupt vessel closure)
• Radiation injury
• Thrombosis/thrombus
• Vasospasm
• Vessel trauma (arteriovenous fistula, dissection, perforation, pseudoaneurysm, 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.

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