St. Jude Medical gets FDA approval for updated cardiac mapping system

St. Jude Medical's EnSite system

ST. PAUL, Minnesota — The U.S. Food & Drug Administration has approved a new version of St. Jude Medical’s cardiac mapping tool: EnSite Velocity Cardiac Mapping System.

St. Jude acquired the technology in 2004 and has had a version on the market for years. It received European approval for the new EnSite Velolcity in May, and the FDA in January approved a new product in the EnSite Fusion line.

The Velocity is used for minimally invasive electrophysiology procedures, which deal with the electrical charges in the heart. It’s an attractive tool because it exposes patients to fewer X-Rays than other approaches.

The company claims the new EnSite Velocity is easier to set up than older models and has two new features. The first uses multiple catheters and electrodes to collect an image of the heart as well as the electrical charge that pule through out, creating a way to collect important patient information faster. The second allows physicians to watch a procedure in real-time while also reviewing earlier recorded portion of the procedure.

The segment that includes the EnSite products accounts for 10 to 20 percent of St. Jude’s atrial fibrillation revenue annually, company spokeswoman Sara Spafford said. This year through July, the company has generated $754 million in sales — out of a total $2.3 billion — from cardiovascular and atrial fibrillation products.