Need Help?
Contact Us

Indications, Safety and Warnings

Return to product page

Indications

ACUITY™ Steerable IS-1 and EASY TRAK™ 3 coronary venous, steroid-eluting, dual-electrode pace/sense leads are transvenous leads intended for chronic LV pacing and sensing via the coronary veins when used in conjunction with a compatible pulse generator. Extended bipolar pacing and sensing is available using Acuity Steerable with an RV pace/sense/defibrillation lead or a bipolar RV pace/sense lead.

Contraindications

Use of the Acuity Steeable and Easy Trak lead are contraindicated in patients with a hypersensitivity to a nominal dose of 1.0 mg (0.5 mg per electrode) of dexamethasone acetate drug. Some LV lead models are contraindicated in patients with mechanical tricuspid heart valves, or obstructed or inadequate vasculature for intravenous catheterization (Acuity Steerable).

Warnings

Read the product labeling thoroughly before implanting the lead to avoid damage to the system. For single patient use only. Do not reuse, reprocess, or resterilize. When using a right ventricular (RV) pace/sense lead in conjunction with an LV lead, it is recommended that a polyurethane-insulated RV lead be used. The use of battery-powered equipment is recommended during lead implantation and testing. Line-powered equipment used in the vicinity of the patient must be properly grounded. The lead connector must be insulated from any leakage currents that could arise from line-powered equipment. The lead is not designed to tolerate excessive flexing, bending, tension, or injection pressure. When using a finishing wire accessory kit, use the corresponding finishing wire model for the lead length. Do not expose a patient to the MRI environment. Patients with implanted leads should not receive diathermy treatment.. When placing the lead with a stylet, use only a stylet designed for use with the ACUITY Steerable lead. Lead fracture, dislodgement, abrasion, or an incomplete connection can cause a periodic or continual loss of pacing and/or sensing.

Precautions

Refer to the Sterilization and Handling and Lead Evaluation and Implant sections of the product labeling for cautions specific to handling, implanting, and testing the lead. Failure to observe these cautions could result in incorrect lead implantation, lead damage/dislodgment, or harm to the patient.

Potential Adverse Events

Potential adverse events include, but are not limited to the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation /lead tip) hematoma/seroma, inappropriate or inability to provide therapy (pacing/sensing), infection, procedure-related, and component failure. In rare cases severe complications or device failures can occur.

Refer to the product labeling for specific indications, contraindications, warning/precautions and adverse events. Rx only. (Rev. C)

Top