St. Jude Medical won the European CE Mark for its Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D). Like the previously released Quadra Assura, the MP model takes advantage of four electrodes in the compatible Quartet Lead for improved diagnostics and better energy delivery.
In addition, the new device introduces MultiPoint Pacing (MPP), a way by which multiple points on the left side of the heart can be paced concurrently. Electric pulses can be programmed to be delivered simultaneously or sequentially during each pacing cycle.
From SJM:
The new MPP capability allows physicians to program simultaneous or sequential delivery of two left ventricular (LV) pulses per pacing cycle, rather than the standard single pacing pulse. The capability to deliver two LV pulses per cycle allows physicians to tailor CRT pacing for each patient, potentially leading to more effective outcomes compared to single site pacing, which may be particularly beneficial in patients not responding to traditional bi-ventricular pacing therapy.
Preliminary results from a study presented at this year’s Heart Rhythm Society (HRS) Scientific Sessions showed that after three months, 89 percent of patients treated with the St. Jude Medical MPP were classified as responders, an increase of nearly 20 percent. On average, the response rate to traditional CRT is approximately 70 percent.
More than 80 publications provide broad clinical evidence for the advantages of the St Jude Medical quadripolar technology. A number of additional studies are underway to support that MPP may provide improvements in cardiac function and hemodynamics. St. Jude Medical is currently conducting a pivotal U.S. clinical study, under an Investigational Device Exemption (IDE), on the MultiPoint™ CRT pacing feature. The study is evaluating outcome benefits such as improved hemodynamics (blood flow) and cardiac function in heart failure patients who receive CRT. Additionally, a single-center, research study will compare six month efficacy of CRT with MPP at various programmed parameters. The results from these studies will strengthen the clinical evidence for MPP. Additionally, starting later this year, a European post-market study will further evaluate the efficacy of MPP therapy in patients not responding to traditional CRT.
Flashback: St. Jude Medical Wins EU Approval for Assura Line of Implantable Defibrillators
Press release: St. Jude Medical Receives CE Mark Approval of MultiPoint Pacing CRT-D…
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