St. Jude snags CE mark for flexible pacer

St. Jude won a CE mark for the Quadra Assura MP.--Courtesy of St. Jude

St. Jude Medical ($STJ) is headed to Europe with the Quadra Assura MP, winning CE mark approval for a device the company said can pace multiple locations on the left side of the heart and increase the number of patients who respond to therapy.

The device, paired with St. Jude's Quartet lead, boasts four customizable electrodes, delivering charges at locations and intervals determined by physicians. Through the so-called MultiPoint Pacing system, the implant allows more patients than ever before to benefit from cardiac resynchronization therapy, St. Jude said. In preliminary results from the device's pivotal trial, 89% of heart-failure sufferers treated with Quadra Assura MP were classified as responders, a nearly 20% jump over traditional CRT.

"Many patients with heart failure have scar tissue on their cardiac anatomy that makes it difficult to provide them with optimal and effective therapy," investigator and Maria Cecilia Hospital physician Carlo Pappone said in a statement. "The new MultiPoint Pacing technology helps individualize therapy for each of my patients and potentially allows those patients unable to benefit from traditional cardiac resynchronization therapy to be effectively treated."

As St. Jude prepares to roll out Quadra Assura MP to European doctors, the company is recruiting more than 500 patients at 50 centers in the U.S. for a study designed to win FDA approval. St. Jude will test the device on patients with heart failure who don't respond to existing CRT devices, looking to eventually pitch its implant to the nearly 5 million Americans who suffer from the disease.

All of which would be good news for St. Jude's flagging cardiac rhythm management business. Last quarter, CRM revenue slid 8%, fueled by a 12% drop in pacemaker sales. And while St. Jude is still counting on company-wide growth in 2013, CFO John Heinmiller said the company expects cardiac revenues to decline about 4% on the year.

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