FDA approves St. Jude Medical’s cardiac mapping system
The FDA cleared the EnSite Precision cardiac mapping system and the Advisor FL circular mapping catheter for patients with cardiac arrhythmias.
St. Jude Medical, which manufactures the mapping system and catheter, announced the approvals in a news release on Dec. 15.
The company said that that EnSite Precision cardiac mapping system provides physicians with a live view of the heart, anatomical models and maps to help them treat atrial fibrillation, ventricular tachycardia and other arrhythmias.
The EnSite Precision is based on St. Jude Medical’s Ensite Velocity cardiac mapping system, which the company said is in use in more than 2,000 electrophysiology laboratories. The EnSite Precision features a module that the company said would allow physicians to build a map of the heart 10 times faster than current systems.
The EnSite Precision received a CE Mark in Europe in January.