St. Jude Medical Gets European CE Mark Approval for Its Quadripolar Pacing System

St. Jude Medical, Inc. said that it has received European CE Mark approval for the industry's first quadripolar pacing system for cardiac resynchronization therapy defibrillators (CRT-Ds).

In a release, the Company noted that the quadripolar system offers physicians the ability to more effectively and efficiently manage the ever-changing pacing needs of patients with heart failure. It integrates multiple pacing options and features that enable physicians to better manage common pacing complications without having to surgically reposition the lead.

"Managing heart failure patients is often challenging and typically involves ongoing medical management," said Dr. Klaus Gutleben, consultant cardiologist at the Heart and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen, Germany. "This new quadripolar pacing system provides more options for managing the needs of my patients with heart failure and reduces the patient's risk of needing multiple surgical procedures, which should lead to more efficient patient care."

St. Jude said that the quadripolar system, with the Quartet left ventricular pacing lead, features four pacing electrodes on the left ventricular lead - enabling up to 10 pacing configurations. Multiple pacing configurations provide physicians with more options to pace around scar tissue in the heart and avoid common pacing complications without the need to surgically reposition the lead.

"The new features offered in this quadripolar system allow me to mitigate potential complications that would otherwise require an invasive procedure to re-place or reposition the left ventricular lead," said Dr. Johannes Sperzel of the Kerckhoff Klinik in Bad Nauheim, Germany. "Moreover, the lead maintains excellent handling characteristics, as the additional electrodes do not impact my ability to place the lead in the targeted vein."

"CRT has been demonstrated as an important treatment in reducing symptoms and slowing the progression of heart failure. This new system gives physicians more control over patient therapy by providing the flexibility to non-invasively adjust the pacing location or configuration," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "This approval of the industry's first quadripolar pacing system is demonstrative of St. Jude Medical's commitment to providing physicians with novel technology that addresses clinical needs."

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide.

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