St. Jude Medical Announces CE Mark Approval For Heart Device Allowing Pacing in Multiple PointsSt. Jude Medical Announces CE Mark Approval For Heart Device Allowing Pacing in Multiple Points
St. Jude Medical has received European regulatory approval for the next generation CRT-device that allows pacing to occur at multiple locations in the heart.
June 24, 2013

St. Jude Medical announced Monday that a new heart device built upon its unique Quadra cardiac resynchronization therapy device has won CE Mark clearance in Europe.
The Quadra Assura MP cardiac resynchronization therapy defibrillator allows heart pacing to occur at several locations on the left side of the heart. This in turn gives the clinician more choice in finding the optimal CRT-D therapy that can meet patients' individual needs.
Like its previous generation device, the Quadra Assura MP product uses the company's Quartet lead, which has four electrodes so that pacing can be done in different configurations. Add to that the new multiple-point pacing capability that enables physicians to program the device such that two two left ventricular (LV) pulses either simultaneously or sequentially can be delivered per pacing cycle to the patient instead of the standard single pacing pulse.
St. Jude believes that the capability to deliver two LV pulses per cycle allows a more tailored CRT pacing approach for each patient, that can lead to more effective outcomes compared to single site pacing, which may be "particularly beneficial in patients not responding to traditional bi-ventricular pacing therapy," a news release noted.
"Many patients with heart failure have scar tissue on their cardiac anatomy that makes it difficult to provide them with optimal and effective therapy. 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,” said Prof. Carlo Pappone, director of the Department of Arrhythmology at Maria Cecilia Hospital, GVM Care & Research in Cotignola, Italy, in the St. Jude news release.
Senior analyst Glenn Novarro of RBC Capital Markets believes that St. Jude Medical's Quadra Assura CRT-D that uses the Quartet lead is one of the more innovative devices the company has, allowing the Minnesota device maker to gain share in the tri-chamber ICD market while maintaining share in the overall defibrillator market instead of losing ground.
No doubt St. Jude Medical will hope for the same result once the next generation device, now available in Europe, is also commercialized in the U.S. St. Jude announced the first enrollments in the trial to get FDA approval on May 2.
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