St Jude Medical has obtained CE mark from the European Union for its Allure Quadra cardiac resynchronisation therapy pacemaker (CRT-P).
The quadripolar CRT-P, which is integrated with the quadripolar technology with multiple pacing configurations, includes TailoredTherapy feature that enables physicians to address heart failure (HF) challenges by optimizing the quadripolar system at implant and follow-up.
In addition, the device improves HF management with timely access to vital diagnostic data including CorVue Impedance monitoring for earlier insight into HF progression, and Direct Trend Reports for a simplified look at all device data.
St. Jude Medical implantable electronic systems division president Eric Fain said the company has seen benefits of efficiency and efficacy with its quadripolar CRT-D platform since its launch in 2010 and is expecting the same results in the quadripolar CRT-P line.
"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 resynchronization therapy," Fain added.
The company said the device is currently not approved for use in the US.
Image: Allure Quadra CRT-P. Photo: Courtesy of St Jude Medical .