St. Jude gains CE mark for first pacemaker with MultiPoint Pacing

St. Jude ($STJ) thinks it has built a better pacemaker, an ongoing obsession of the medical device giants in pursuit of defending their market turf. The company has gained approval for a quadripolar cardiac resynchronization therapy pacemaker (CRT-P) that for the first time incorporates its MultiPoint Pacing technology that's been shown to be better for patients who don't respond to traditional biventrical pacing.

Its Cardiac Rhythm Management (CRM) business is in need of a bit of resuscitation. Last quarter, its CRM sales were $688 million, up only 1% from the same quarter a year earlier. That's a slower pace than the overall growth for its net sales, which increased by 3% to $1.37 billion during the third quarter.

The newly CE-marked Quadra Allure MP has four electrodes, like some of its competitor products, and the MultiPoint Pacing tech allows surgeons to place them in multiple locations of the left side of the heart. That's intended to enable physicians to better optimize use of the device and reduce the need for revisions. MultiPoint Pacing may also reduce premature ventricular contractions, which could improve the effectiveness of CRT.

In clinical testing, the company's MultiPoint Pacing technology offered a 19% improvement in patient responder rates over 12 months as compared with traditional CRT methods, the company noted. Researchers also found that it improved left-ventricular function in patients who were responders to traditional CRT.

Daniel Starks

"Although most competitors now have added a quadripolar CRT offering to their product lines, we think that St. Jude Medical's lead in clinical evidence, our advantage in lead handling characteristics, the first and only quadripolar CRT-P device, and our unique MultiPoint Pacing technology will continue to sustain our competitive advantage in this portion of our product portfolio," St. Jude chairman, president and CEO Daniel Starks said on the company's third quarter earnings call.

The Quadra Allure MP CRT-P is designed to work with the Quartet LV lead. The Quartet LV showed a 40% reduction in risk of lead complications in clinical trial data from earlier this year.

St. Jude launched the first quadripolar lead device in 2011 and introduced a CRT-P with a quadripolar lead into the market in April 2013, with the Allure Quadra. In June 2013, it rolled out a defibrillator with four electrodes and the MultiPoint Pacing tech.

"From our initial experience, we think MultiPoint Pacing improves cardiac function, resulting in better resynchronization and could be a further advantage of CRT," study investigator Dr. Francesco Zanon, director of the Electrophysiology Unit Department of Cardiology from Santa Maria della Misericordia Hospital in Rovigo, Italy, said in a statement. "We observed significant improvement over traditional CRT pacing, and therefore believe this technology could have wide application because it is accessible for all CRT implanters."

Not to be outdone in the news cycle, competitor Medtronic ($MDT) said it received FDA approval for two additional Attain Performa left ventricular (LV) quadripolar leads that work with its Quad XT and Viva Quad S defibrillators.

- here are the releases from St. Jude and Medtronic

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