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St Jude Medical receives CE Mark clearance for Quadra Assura MP CRT-D

St. Jude Medical has received CE Mark clearance for its next-generation quadripolar device called Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D).

Quadra Assura MP(TM) CRT-D

Featuring MultiPoint Pacing (MPP) technology, the Quadra Assura MP CRT-D is built upon the company’s Quadripolar Pacing System that is designed to pace the multiple locations on the left side of the heart.

The technology is claimed to help physicians optimize cardiac resynchronization therapy (CRT) pacing to serve the patients better.

In combination with the Quartet Lead, which has four electrodes to provide maximum flexibility for different pacing configurations, the device allows physicians to choose between simultaneous or sequential delivery of two left ventricular (LV) pulses per pacing cycle, instead of the regular single pacing pulse.

Being capable of delivering two LV pulses per cycle, is expected to generate more outcomes when compared to single site pacing, thereby benefiting patients who usually don’t respond to conventional pacing therapy.

GVM Care & Research Italy, Maria Cecilia Hospital Arrhythmology department director Carlo Pappone said that 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," Pappone added.

Claimed to be improving the quality of life for several heart failure patients, the delivery of CRT pacing through an implantable cardioverter defibrillator (ICD), is said to resynchronize the beating of the heart’s lower chambers (ventricles).

St. Jude Medical Implantable Electronic Systems Division president Eric Fain said that Quadripolar pacing has become the standard of care to many physicians.

"We are pleased to continue our innovation by offering the industry’s first MultiPoint Pacing system, which provides a new set of non-invasive tools to address patients who are non-responders to traditional CRT pacing, potentially decreasing heart failure hospitalizations and lowering the economic burden," Fain added.

A study has been conducted at Heart Rhythm Society (HRS) Scientific Sessions in 2013, the results of which demonstrated that 89% of patients treated with MPP were classified as responders with an increase of about 20%. The response rate of the conventional CRT is observed to be nearly 70% on average.

Quadra Assura MP CRT-D is an investigational device in the US, which is not commercially approved in the US.

Image: Quadra Assura MP CRT-D. Photo: Courtesy of St. Jude Medical.