ION™ Paclitaxel-Eluting

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 ION Stent System is indicated for improving luminal diameter:

• for the treatment of de novo lesions in native coronary arteries 2.25 mm to 4.00 mm in diameter in lesions ≤ 34 mm in length; or
• in patients undergoing primary angioplasty to treat acute ST-segment elevation myocardial infarction, true posterior myocardial infarction, or presumed new left bundle branch block with symptoms of acute myocardial infarction lasting > 20 minutes and < 12 hours in duration.

CONTRAINDICATIONS

Use of the ION Stent System is contraindicated in patients with:

• Known hypersensitivity to 316L stainless steel or platinum.
• Known hypersensitivity to paclitaxel or structurally-related compounds.
• Known hypersensitivity to the polymer or its individual components (see Section 2.2.2., Translute Polymer Carrier for more information). 

Coronary Artery Stenting is contraindicated for use in:

• Patients who cannot receive recommended antiplatelet and/or anticoagulant therapy (see Section 6.2 Pre- and Post-Procedure Antiplatelet Regimen for more information).
• Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.

WARNINGS

• The use of this product carries the risks associated with coronary artery stenting, including stent thrombosis, vascular complications, and/or bleeding events.
• This product should not be used in patients who are not likely to comply with recommended antiplatelet therapy.

PRECAUTIONS

General Precautions

• Only physicians who have received adequate training should perform stent implantation.
• Stent placement should only be performed at hospitals where emergency coronary artery bypass graft surgery can be readily performed.
• Subsequent stent blockage may require repeat dilatation of the arterial segment containing the stent. The long-term outcome following repeat dilatation of endothelialized stents is not well-characterized.
• Consideration should be given to the risks and benefits of use in patients with history of severe reaction to contrast agents.
• Before withdrawing the Stent Delivery System (SDS), visually confirm complete balloon deflation by fluoroscopy (See Table 6.1.2 System Deflation Time Specifications). • Stent thrombosis is a low frequency event that current drug-eluting stent (DES) clinical trials are not adequately powered to fully characterize. Stent thrombosis is frequently associated with myocardial infarction (MI) or death. 
• When drug-eluting stents are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the pivotal clinical trials.
• Compared to use within the specified Indications for Use, the use of drug-eluting stents in patients and lesions outside of the labeled Indications, may have an increased risk of adverse events, including stent thrombosis, stent embolization, myocardial infarction, or death.

Pre-and Post-Procedure Antiplatelet Regimen

The optimal duration of antiplatelet therapy, specifically clopidogrel, is unknown and DES thrombosis may still occur despite continued therapy. Provided herein are recent recommendations from the 2011 ACCF/ AHA/SCAI Guideline for Percutaneous Coronary Intervention (PCI), Section 6.2.1. Oral Antiplatelet Therapy For Elective PCI Procedures Continuation of combination treatment with aspirin and a P2Y12 inhibitor after PCI appears to reduce major adverse cardiac events. On the basis of randomized clinical trial protocols, secondary prevention measures, and expert consensus opinion, aspirin 81 mg daily should be given indefinitely after PCI. Likewise, a P2Y12 inhibitor should be given daily for at least 12 months in patients who are not at high risk of bleeding. Full guidelines are provided at the following website: https://content.onlinejacc.org/cgi/content/short/58/24/2550

For PCI in ST-Elevation MI (STEMI) Patients There are ACC/AHA Guidelines for the Management of Patients with ST-Elevation Myocardial Infarction1 

Premature discontinuation of prescribed antiplatelet medication could result in a higher risk of thrombosis, myocardial infarction or death. Prior to PCI, if a surgical or dental procedure is anticipated which requires early discontinuation of antiplatelet therapy, the interventional cardiologist and patient should carefully consider whether a drugeluting stent and its associated recommended antiplatelet therapy is the appropriate PCI choice. Following PCI, should a surgical or dental procedure be recommended that requires suspension of antiplatelet therapy, the risks and benefits of the procedure should be weighed against the possible risk associated with premature discontinuation of antiplatelet therapy. Generally, it is recommended to postpone elective surgery for one year and among those patients for whom surgery can be deferred, ASA should be considered during perioperative period in high risk DES patients. Patients who require premature discontinuation of antiplatelet therapy secondary to significant active bleeding should be monitored carefully for cardiac events and, once stabilized, have their antiplatelet therapy restarted as soon as possible per the discretion of their treating physicians.

Use of Multiple Stents

The use of multiple drug-eluting stents will expose the patient to larger amounts of drug and polymer.  When multiple overlapping stents are used resulting in stent to stent contact, it is suggested that the stents be adequately overlapped to avoid the potential for gap restenosis. 

Brachytherapy

The safety and effectiveness of the ION Stent in patients with prior brachytherapy of the target lesion have not been established. 

Use in Conjunction with Other Procedures

The safety and effectiveness of using mechanical atherectomy devices (directional atherectomy catheters, rotational atherectomy catheters) or laser angioplasty catheters in conjunction with ION Stent implantation have not been established. 

Pediatric Use

The safety and effectiveness of the ION Stent in pediatric patients have not been established.

Lesion/Vessel Characteristics

The safety and effectiveness of the ION Stent have not been established in the cerebral, carotid, or peripheral vasculature or the following patient populations:

• Patients with vessel thrombus at the lesion site. 
• Patients with coronary artery reference vessel diameters < 2.25 or > 4.00 mm.
• Patients with coronary artery lesions longer than 34 mm or requiring more than one ION Stent.
• Patients with lesions located in the saphenous vein grafts, in the unprotected left main coronary artery, ostial lesions, or lesions located at a bifurcation.
• Patients with diffuse disease or poor flow distal to the identified lesions.
• Patients with tortuous vessels (> 60 degrees) in the region of the obstruction or proximal to the lesion.
• Patients with in-stent restenosis.
• Patients with moderate or severe calcification in the lesion or a chronic total occlusion.
• Patients with multi-vessel disease.

Drug Interaction

Because systemic levels of paclitaxel have not been detected post-stent placement in clinical trials, possible interactions of paclitaxel with concomitantly administered medications are unlikely to be detectable. 

Magnetic Resonance Imaging (MRI)

The ION™ Stent has been shown to be MR Conditional (poses no known hazards under specified conditions) through nonclinical testing of single and overlapped configurations up to 74 mm in overall length. The conditions are as follows: 

• Field strengths of 1.5 and 3 Tesla
• Static magnetic field gradient < 9 T/m (extrapolated)
• Normal operational mode (maximum whole body averaged specific absorption rate (SAR) of lower than 2.0 W/kg) for a total active MR scan time (with RF exposure) of 15 minutes or less 

Magnetic Resonance MR Conditional Stent Handling
(also see Section 14, Operational Instructions)

• For single use only. Do not resterilize or reuse this product. Note product “Use By” date. (See Warning - Section 1) 
• The premounted ION Stent and its delivery system are designed for use as a unit. 
• Use only the appropriate balloon inflation media (see Operational Instructions - Section 14.3.3, Balloon Preparation). Do not use air or any gas medium to inflate the balloon.

Stent Placement
Preparation

• An unexpanded stent should be introduced into the coronary arteries one time only. An unexpanded stent should not be subsequently moved in and out through the distal end of the guide catheter as stent or coating damage or stent dislodgment from the balloon may occur.

Placement

• Do not expand the stent if it is not properly positioned in the vessel (see Precautions - Section 6.12, Stent System Removal). 
• Do not exceed rated burst pressure as indicated on product label (see Table 14.5.1. Typical ION Stent System compliance). 
• Placement of the stent has the potential to compromise side branch patency.
• Implanting a stent may lead to dissection of the vessel distal and/or proximal to the stented portion, and may cause acute closure of the vessel requiring additional intervention (e.g. CABG, further dilation, placement of additional stents, or other). 
• When treating multiple lesions, the distal lesion should be initially stented, followed by stenting of the more proximal lesion(s). 

Stent System Removal

• If unusual resistance is felt at any time during lesion access before stent implantation, the stent system and the guide catheter should be removed as a single unit.
• Do not attempt to pull an unexpanded stent back into the guide catheter, as stent or coating damage or stent dislodgment from the balloon may occur.
• Stent retrieval methods (use of additional wires, snares and/ or forceps) may result in additional trauma to the vascular site. 

Post-Procedure

• Care must be exercised when crossing a newly deployed stent with any wire, catheter or ancillary device to avoid disrupting the stent placement, apposition, and/or coating.

Potential Adverse Events

Potential adverse events (in alphabetical order) which may be associated with the use of a coronary stent in native coronary arteries include but are not limited to:

• Abrupt stent closure
• Acute myocardial infarction
• Allergic reaction to anti-coagulant and/or antiplatelet therapy, contrast medium, or stent materials
• Angina
• Arrhythmias, including ventricular fibrillation and ventricular tachycardia
• Arteriovenous fistula
• Cardiac tamponade
• Cardiogenic shock/pulmonary edema
• Coronary aneurysm
• Death
• Dissection
• Emboli, distal (air, tissue or thrombotic material or material from devices(s) used in the procedure)
• Heart failure
• Hematoma
• Hemorrhage, required transfusion
• Hypotension/hypertension
• Infection, local or systemic
• Ischemia, myocardial
• Pain, access site
• Perforation or rupture of coronary artery
• Pericardial effusion
• Pseudoaneurysm, femoral
• Renal failure
• Respiratory failure
• Restenosis of stented segment
• Stent embolization or migration
• Stent thrombosis/occlusion
• Stroke/cerebrovascular accident /TIA
• Total occlusion of coronary artery
• Vessel spasm
• Vessel trauma requiring surgical repair or reintervention 

Potential adverse events not captured above, that may be unique to the paclitaxel drug coating:

• Allergic/immunologic reaction to drug (paclitaxel or structurally-related compounds) or the polymer stent coating (or its individual components) 
• Alopecia
• Anemia
• Blood product transfusion
• Gastrointestinal symptoms
• Hematologic dyscrasia (including leukopenia, neutropenia, thrombocytopenia)
• Hepatic enzyme changes
• Histologic changes in vessel wall, including inflammation, cellular damage or necrosis
• Myalgia/arthralgia
• Peripheral neuropathy

There may be other potential adverse events that are unforeseen at this time.