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St. Jude's New Quadra Study

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St. Jude Medical has enrolled the first patient for its MultiPoint Pacing clinical study. The study will evaluate the efficacy of the company’s Quadripolar Pacing system belonging to the implantable cardioverter defibrillator (ICD) product line under the larger Cardiac Rhythm Management (CRM) division.

Quadripolar Pacing is becoming the new standard of care in cardiac resynchronization therapy (CRT). MultiPoint Pacing technology delivers pacing to multiple locations in the heart rather than the traditional single pulse for each heartbeat. The study will analyze the benefits of St. Jude’s one-of-a-kind Quadra Assura MP CRT-D and Quartet lead in delivering improved hemodynamic support in patients receiving CRT.

The MultiPoint Pacing clinical study is being conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). The study will enroll more than 500 patients across 50 centers in the U.S. As per the Heart Failure Society of America, about 5 million people in the U.S are suffering from heart failure with roughly 400,000 to 700,000 new patients diagnosed annually.

St. Jude Medical is the only company that offers quadripolar CRT-D technology in the U.S. and Japan and has recently launched the world’s first quadripolar MultiPoint Pacing technology in Europe. This provides a competitive advantage to the company’s CRT segment to gain market share in the ICD market.

St. Jude’s core CRM division is still underperforming. Revenues from the CRM division fell 8% year over year in the first quarter of 2013. The beleaguered ICD market, as reflected by sustained implant volume pressure and the Riata/Durata lead issue, continues to hurt CRM results. ICD sales declined 5% in the first quarter but we believe that market trends will stabilize soon.

Additionally, the pacemaker business under CRM is currently losing market share due to competitive pressure. Recently, the company received CE Mark approval for its Allure Quadra Cardiac Resynchronization Therapy Pacemaker (CRT-P). It is the world’s first pacemaker with the quadripolar lead technology. The European launch of this product should help STJ’s soft pacemaker business to regain some lost market share.

St. Jude’s peer Boston Scientific (BSX - Free Report) also reported disappointing CRM sales in the first quarter of 2013, indicating sustained softness in the CRM market.

St. Jude currently carries a Zacks Rank #3 (Hold). While we remain on the sidelines regarding STJ, medical stocks such as Conceptus and Coventry Health Care warrant a look.

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