Skip to main content

My account

Boston Scientific accounts are for healthcare professionals only.

Create an account to access online training and education on EDUCARE, manage your customer profile, and connect with customer support and service teams.

My Boston Scientific account

Access your online applications and manage your customer profile.

Manage my Boston Scientific account

Quick Links

Contact a representative
Online education and training
Order products online
Reimbursement resources
Return a product
Customer support

Call customer care

1 (888) 272-1001

Indications, safety, and warnings

ACUITY™ X4 Quadripolar LV Leads

Rx Statement    

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.

INDICATIONS AND USAGE

This Boston Scientific lead is indicated for use as follows:

  • Intended for chronic, left-ventricular pacing and sensing via the coronary venous system when used in conjunction with a compatible pulse generator. The Boston Scientific ACUITY X4 lead is a steroid-eluting (dexamethasone acetate) IS4 quadripolar lead.

CONTRAINDICATIONS

Use of this Boston Scientific lead is contraindicated for the following patients:

  • Patients with a hypersensitivity to dexamethasone acetate

WARNINGS

General

  • Labeling knowledge. Read this manual thoroughly before implantation to avoid damage to the pulse generator and/or lead. Such damage can result in patient injury or death. 

  • Resuscitation availability. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing in case the patient requires external rescue. 

  • Use of right ventricular lead. When using a right ventricular (RV) pace/sense lead in conjunction with this left coronary venous pace/sense lead, it is recommended that a polyurethane-insulated RV lead be used. Failure to observe this warning could result in insulation damage of the RV lead, which can cause periodic or continual loss of pacing, sensing, or both. 

Handling

  • Excessive flexing. Although pliable, the lead is not designed to tolerate excessive flexing, bending, or tension. This could cause structural weakness, conductor discontinuity, and/or lead dislodgment. 

  • Do not kink leads. Do not kink, twist, or braid the lead with other leads, as doing so could cause insulation abrasion damage or conductor damage. 

  • Handling the lead without Connector Tool. Use caution when handling the lead terminal if the Connector Tool is not present. Do not directly contact the lead terminal with surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, or clamps. This could damage the terminal, compromise sealing integrity, and result in loss of therapy or inappropriate therapy. 

  • Handling the terminal while tunneling. Do not contact any portion of the lead terminal other than the terminal pin, even when the lead cap is in place. 

  • Appropriate lead connections. When implanting a system that uses both a DF4-LLHH/LLHO and an IS4-LLLL lead, ensure that the leads are inserted and secured in the appropriate ports. Inserting a lead into an incorrect port will result in unanticipated device behavior and may leave the patient without effective therapy. 

Implant Related

  • Only use Connector Tool for electrical connections. Only use the Connector Tool for electrical connections to pacing system analyzers or similar monitors. Do not attach alligator clips directly to the lead terminal, as damage could occur. 

  • Proper connections. When connecting the lead to the pulse generator, it is critical that proper connections are made. An improper connection could result in loss of therapy or inappropriate therapy. 

Post-Implant

  • Magnetic Resonance Imaging (MRI) exposure. Unless all MRI Conditions of Use (as described in the MRI Technical Guide) are met, MRI scanning does not meet MR Conditional requirements for the implanted system and may result in significant harm, death of the patient, and/or damage to the system. Refer to the MRI Technical Guide for potential adverse events and a complete list of MRI-related warnings and precautions. 

  • Diathermy. Do not subject a patient with an implanted pulse generator and/or lead to diathermy, as it may cause fibrillation, myocardial burning, and irreversible damage to the pulse generator due to induced currents.

MR Conditional System Information

These leads can be used as part of the ImageReady MR Conditional Pacing System or the ImageReady MR Conditional Defibrillation System (hereafter each referred to as an MR Conditional System) when connected to Boston Scientific MR Conditional pulse generators. Patients with an MR Conditional System may be eligible to undergo MRI scans if performed when all Conditions of Use, as defined in the applicable MRI Technical Guide, are met. Components required for MR Conditional status include specific models of Boston Scientific pulse generators, leads, and accessories; the Programmer and Programmer Software Application. For the model numbers of MR Conditional pulse generators and components, as well as a complete description of the ImageReady MR Conditional System, refer to the applicable MRI Technical Guide.

Implant-related MRI Conditions of Use

The following subset of the MRI Conditions of Use pertains to implantation, and is included as a guide to ensure implantation of a complete ImageReady MR Conditional System. For a full list of Conditions of Use, refer to the MRI Technical Guide. All items on the full list of Conditions of Use must be met in order for an MRI scan to be considered MR Conditional.

  • Patient is implanted with the ImageReady MR Conditional Pacing System or the ImageReady MR Conditional Defibrillation System

  • No other active or abandoned implanted devices, components, or accessories present such as lead adaptors, extenders, leads, or pulse generators

  • Pulse generator implant location restricted to left or right pectoral region

  • At least six (6) weeks have elapsed since implantation and/or any lead revision or surgical modification of the MR Conditional System

PRECAUTIONS

Clinical Considerations

  • Dexamethasone acetate. Dexamethasone acetate is a glucocorticoid that is hydrolyzed into dexamethasone upon exposure to the surrounding tissue and body fluid. It has not been determined whether the warnings, precautions, or complications usually associated with injectable dexamethasone apply to the use of a low concentration, highly localized, controlled-release device. Systemic side effects associated with glucocorticoids, when administered locally at the site of device implantation in the myocardium, have not been reported7. A listing of potential adverse events associated with injectable dexamethasone is available in resources such as authorized summaries of product characteristics (SmPC) on European Union health authority websites or the Physicians' Desk Reference™ 8 (www.pdr.net).

Sterilization and Storage

  • Storage temperature. Store at 25°C (77°F). Excursions are permitted between 15°C to 30°C (59°F to 86°F). Transportation spikes are permitted up to 50°C (122°F).

Handling

  • Do not immerse in fluid. Do not wipe or immerse the tip electrode in fluid. Such treatment will reduce the amount of steroid available when the lead is implanted.

  • Chronic repositioning. Optimum threshold performance might not be achieved if the lead is chronically repositioned because the steroid can be depleted.

  • No mineral oil on lead electrodes. Mineral oil should never come in contact with the lead electrodes. Mineral oil on the electrodes may inhibit conduction.

Implantation

  • Line-powered equipment. Exercise extreme caution if testing leads using line-powered equipment because leakage current exceeding 10 μA can induce ventricular fibrillation. Ensure that any line-powered equipment is within specifications.

  • Do not bend the lead near the lead-header interface. Insert the lead terminal straight into the lead port. Do not bend the lead near the lead-header interface. Improper insertion can cause insulation or connector damage.

  • Venogram risks. Risks associated with coronary venography are similar to any other catheterization procedure in the coronary sinus. Some patients can have poor renal function or a physical intolerance to different types of contrast agents. If this is known in advance, select an appropriate agent. The type, amount, and rate of injection of the contrast medium must be determined by physician medical judgment regarding the adequacy of the venogram obtained.

  • Clotted lead. Flushing a clotted lead can compromise lead integrity. If clotting is suspected, remove the lead from the body and soak the lead in heparinized saline. Insert a guide wire into either the terminal or distal tip of the lead and advance the wire to clear clotting. If unsuccessful, use a new lead.

  • Tools applied to distal end. Do not apply tools to the distal end of the lead because lead damage could occur. Avoid holding or handling the distal tip of the lead.

  • Inserting guide wire. Use care when inserting the proximal end of a guide wire into the distal tip of the leads. If inserted too quickly and/or roughly, the stiff end of the guide wire may damage the lead lumen and affect the lead performance.

  • Do not kink the guide wire. Do not kink the guide wire in the lead. Kinking the guide wire could lock it in the lead or damage the conductor coil.

  • Use of multiple suture sleeves has not been evaluated. Use of multiple suture sleeves has not been evaluated and is not recommended.

  • Tunnel the lead. Tunnel the lead from the chest area to the pulse generator implant site. Do not tunnel the lead from the pulse generator implant site to the chest area because this can damage the electrodes or lead body or both by permanently stretching the lead.

  • Excessive tension on lead. When tunneling the lead, take precautions not to place excessive tension on the lead. This can cause either structural weakness and/or conductor discontinuity.

  • Re-evaluate the lead after tunneling. After tunneling, re-evaluate the lead to verify that no significant change in signals or damage to the lead has occurred during the tunneling procedure. Reattach the Connector Tool and repeat the steps in Evaluating Lead Performance.

Hospital and Medical Environments

  • Electrocautery. Electrocautery may induce ventricular arrhythmias and/or fibrillation, and may cause asynchronous pacing, inhibition of pacing, and/or a reduction in pulse generator pacing output possibly leading to loss of capture. If electrocautery is medically necessary, observe the following to minimize risk to the lead. Also, refer to pulse generator labeling for device programming recommendations and additional information about minimizing risk to the patient and system

    • Avoid direct contact between the electrocautery equipment and the pulse generator or leads.
    • Keep the path of the electrical current as far away as possible from the pulse generator and leads.
    • If electrocautery is performed on tissue near the device or leads, monitor pre and post- measurements for sensing and pacing thresholds and impedances to determine the integrity and stability of the system.
    • Use short, intermittent, and irregular bursts at the lowest feasible energy levels.
    • Use a bipolar electrocautery system where possible.

 

  • Radio frequency (RF) ablation. RF ablation may induce ventricular arrhythmias and/or fibrillation, and may cause asynchronous pacing, inhibition of pacing, and/or a reduction in pulse generator pacing output possibly leading to loss of capture. RF ablation may also cause ventricular pacing up to the Maximum Tracking Rate (MTR) and/or changes in pacing thresholds. Additionally, exercise caution when performing any other type of cardiac ablation procedure in patients with implanted devices. If RF ablation is medically necessary, observe the following to minimize risk to the lead. Also, refer to pulse generator labeling for device programming recommendations and additional information about minimizing risk to the patient and system.

    • Avoid direct contact between the ablation catheter and the pulse generator and leads. RF ablation close to the lead electrode may damage the lead-tissue interface.
    • Keep the path of the electrical current as far away as possible from the pulse generator and leads.
    • If RF ablation is performed on tissue near the device or leads, monitor pre- and post-measurements for sensing and pacing thresholds and impedances to determine the integrity and stability of the system.
  • Central line guidewire insertion. Use caution when inserting guidewires for placement of other types of central venous catheter systems such as PIC lines or Hickman catheters in locations where pulse generator leads may be encountered. Insertion of such guidewires into veins containing leads could result in the leads being damaged or dislodged.

Explant and Disposal

  • Handling at time of disposal. Clean and disinfect the device using standard biohazard handling techniques since all explanted components are considered biohazardous.

POTENTIAL ADVERSE EVENTS

Based on the literature and on pulse generator and/or lead implant experience, the following alphabetical list includes the possible adverse events associated with implantation of products described in this literature:

Acceleration of arrhythmias; Adverse reaction to procedure (e.g., bradycardia, general, respiratory, hypotension); Air embolism; Allergic reaction; Arterial damage with subsequent stenosis; Bleeding; Bradycardia; Breakage/failure of the implant instruments; Cardiac perforation; Cardiac tamponade; Chronic nerve damage; Component failure; Conductor coil fracture; Coronary venous spasm; Death; Electrolyte imbalance/dehydration; Elevated thresholds; Erosion; Excessive fibrotic tissue growth; Extracardiac stimulation (muscle/nerve stimulation); Fluid accumulation; Foreign body rejection phenomena; Formation of hematomas or seromas; Heart block; Hemorrhage; Hemothorax; Inability to pace; Inappropriate therapy (e.g., shocks and antitachycardia pacing [ATP] where applicable, pacing); Incisional pain; Incomplete lead connection with pulse generator; Infection including endocarditis; Lead dislodgment; Lead fracture; Lead insulation breakage or abrasion; Lead tip deformation and/or breakage; Malignancy or skin burn due to fluoroscopic radiation; Myocardial trauma (e.g., irritability, injury, tissue damage); Myopotential sensing; Oversensing/undersensing; Pacemaker-mediated tachycardia (PMT); Pericardial rub; effusion; Pneumothorax; Pulse generator and/or lead migration; Shunting current or insulating myocardium during defibrillation with internal or external paddles; Syncope; Tachyarrhythmias, which include acceleration of arrhythmias and early, recurrent atrial fibrillation; Thrombosis/thromboemboli; Valve damage; Vasovagal response; Venous occlusion; Venous trauma (e.g., perforation, dissection, erosion)

Additionally, potential adverse events associated with the implantation of a coronary venous lead system include: Allergic reaction to contrast media; Prolonged exposure to fluoroscopic radiation; Renal failure from contrast media used to visualize coronary veins. Transient procedural adverse events are expected in some patients. These include, but are not limited to, discomfort, pain, and other systemic symptoms that might be related to medications or other interventions performed during implant.

For a list of potential adverse events associated with MRI scanning, refer to the appropriate ImageReady MR Conditional Pacing System or Defibrillation System MRI Technical Guide. Any serious incident that occurs in relation to this device should be reported to Boston Scientific using the information on the back cover and to the relevant local regulatory authority.

92436276 (Rev. B)