Allure Quadra quadripolar CRT pacemaker gets CE mark

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On 30 April, St Jude Medical announced the CE mark approval and European launch of its Allure Quadra cardiac resynchronisation therapy pacemaker (CRT-P).

According to a company release, Allure Quadra is the first-to-market quadripolar CRT-P system that allows for increased implant efficiencies that result in fewer surgical revisions. It also offers more pacing options to deliver higher success rates, as evidenced by clinical data. The release also stated that the Allure family of devices also offer enhanced heart failure diagnostics, including CorVue Impedance Monitoring, for improved patient management.

“Adding quadripolar technology to the CRT-P platform moves us forward in the treatment of heart failure and allows us to expand the proven clinical benefits to a new patient population,” said Amir Zaidi, consultant cardiologist and devices lead at Manchester Royal Infirmary, UK. “The new features and additional pacing options allow for optimal lead placement and provide the patient greater opportunities to respond to therapy, while reducing the need for re-intervention.”

The new platform of St Jude Medical low-voltage devices includes the only CE mark approved algorithm for identifying stroke risk. The ASSERT (Asymptomatic AF and stroke evaluation in pacemaker patients and the AF reduction atrial pacing trial) study, was designed to determine whether the detection of arrhythmias using pacemaker-based diagnostics predicts an increased risk of stroke in elderly, hypertensive patients without any history of atrial fibrillation.

Results found that pacemaker patients who have no history of atrial tachycardia or atrial fibrillation, but have device-detected arrhythmias, are approximately 2.5 times more likely to have a stroke than patients who do not have device-detected arrhythmias.

“St Jude Medical has seen benefits of efficiency and efficacy with its quadripolar CRT-D platform since its launch in 2010, and we expect the same results in the quadripolar CRT-P line,” said Eric S Fain, president of the Implantable Electronic Systems Division at St Jude Medical. “While determining how to provide high-quality, affordable health care is major social challenge, we believe our quadripolar technology is a cost-effective solution that elevates the standard of care for heart failure patients in need of cardiac resynchronisation therapy.”

The Allure Quadra CRT-P device is currently not approved for use in the USA.