Achieve

Indications, Safety, and Warnings

Indications

The Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e., recording or stimulation only. The Achieve Mapping Catheter is designed to obtain electrograms in the atrial regions of the heart.

Contraindications

The catheter is contraindicated as follows:

• For use as an ablation device
• For use with transseptal sheaths featuring side holes larger than 1.00 mm in diameter
• Retrograde approach

Electrophysiology studies are contraindicated when the patient’s underlying cardiac disease makes it likely that induced arrhythmias will be extremely difficult to terminate and carry a high risk of death, as in the following conditions:

• An active systemic infection
• Left atrial thrombus
• Pulmonary vein stents
• Prosthetic heart valve (tissue or mechanical)
• Myxoma
• Interatrial baffle or patch
• Conditions where the manipulation of the catheter within the heart would be unsafe
• Acute myocardial infarction

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.