CE Mark For St.Jude’s MultiPoint Pacing CRT-D Increases Treatable Patient Group

Newly CE marked QuadraAssura MPPSt.Jude Medical, Inc. has received CE Mark approval of its next-generation quadripolar device, the Quadra Assura MP™ cardiac resynchronization therapy defibrillator (CRT-D).

Background

We’ve covered St.Jude’s frequent announcements on its quadripolar technology quite extensively on our pages. As recently as April this year the company gained CE mark approval for its Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P), subsequent to which it commenced a 500 patient, 50 center, US study.

Building on the technology, the newly CE marked Quadra Assura MP CRT-D features MultiPoint™ Pacing (MPP) capability. St.Jude says this enables physicians to pace multiple locations on the left side of the heart, in theory at least providing more choices to best optimize cardiac resynchronization therapy (CRT) pacing to meet individual patient needs.

The Quadra Assura MP CRT-D is designed to work with the Quartet™ Lead, which has four electrodes to offer maximum flexibility for different pacing configurations. 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, with potentially more effective outcomes compared to single site pacing. This may turn non-responders to traditional bi-ventricular pacing therapy into responders.

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.

Physician comments

“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.

Company comments

“Quadripolar pacing has become the standard of care for 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,” said Eric Fain, president of the St. Jude Medical Implantable Electronic Systems Division.

Regulatory status

Quadra Assura MP™ CRT-D is an investigational device in the U.S and is not commercially approved in the U.S.

Source: St.Jude Medical, Inc., Business Wire