How FDA Approval of EnSite Precision Will Benefit St. Jude’s




On December 15, 2016, St. Jude Medical (STJ) announced the FDA (U.S. Food and Drug Administration) clearance of its EnSite Precision cardiac mapping system and its Advisor FL Circular Mapping Catheter, Sensor Enabled. These are the latest additions to the company’s leading electrophysiology portfolio. Electrophysiology is one of St. Jude Medical’s fastest-growing business segments. It forms part of St. Jude’s atrial fibrillation (or AF) business division.

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St. Jude’s AF business generated around $316 million in sales in 3Q16, which ended September 30, 2016. The business represents around 21% of the company’s total revenues with a YoY (year-over-year) growth rate of 12%. The company expects to see more growth in the electrophysiology ablation space given its immense market potential, as depicted in the diagram below.

The EnSite Precision cardiac mapping system was approved in Europe in January 2016 and has shown strong market adoption and significant sales to date. It’s expected to drive significant company growth in the United States as well.

Stryker (SYK), Boston Scientific (BSX), and Johnson & Johnson’s (JNJ) Biosense Webster are St. Jude Medical’s major competitors in the electrophysiology arena. The Vanguard S&P 500 ETF (VOO) holds ~0.12% of its total holdings in STJ.

Product features and benefits

The EnSite Precision cardiac mapping system enables accurate diagnosis and treatment of cardiac arrhythmias. The system has an advanced user interface and sensor-based catheters and provides a wide range of therapy options and efficient patient management tools for optimum clinical outcomes. It is used in ablation procedures for the accurate visualization and navigation of catheters.


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