St. Jude Medical Inc. (STJ) announced results from a large-scale clinical study revealing that its Quartet left-ventricular (LV) quadripolar lead offers more effective management of common pacing complications compared to systems with bipolar leads, thus enabling better management of heart failure patients.
The MORE-CRT data – More Options available with a quadripolar LV lead pRovidE in clinic solutions to CRT challenges, was presented at the European Society of Cardiology Congress (ESC) 2014. Results disclosed that complications occurred less frequently and were managed more efficiently in patients who received the Quartet lead than in patients who received bipolar electrode leads.
The MORE-CRT study involved a randomized clinical trial of over 1,000 patients. More than 60 centers from 13 countries participated in the study. The primary endpoint of the clinical study was freedom from intra- and post-operative LV lead-related events at six months.
The study, involving a comparison of the St. Jude Medical Quartet lead with bipolar LV leads, further demonstrated that patients implanted with a Quartet lead showed a 40% lower risk of combined LV lead-related events relative to patients implanted with a bipolar LV lead.
Quadripolar Technology
Quadripolar technology aims at revolutionizing Cardiac Resynchronization Therapy (CRT) pacing options in order to facilitate better management of heart failure patients. It enables LV pacing at the preferred site without compromising on lead stability.
Further, the technology can lead to greater CRT implant efficiency, better post-operative efficiency and opportunities to improve CRT efficacy.
The quadripolar pacing technology is specifically more advanced as the failed implant rate in heart failure patients receiving a CRT system with bipolar LV pacing leads is significantly high and may result in complications like anatomy (creating lead stability problems), phrenic nerve stimulation (PNS) or poor electrical measurements.
Data from the MORE-CRT study adds to the growing body of clinical evidence for the St. Jude Medical Quadripolar Lead system and will play a vital role in treatment decision making going forward.
Additional Clinical Evidence
Also presented at the ESC 2014 were 12 month results from the St. Jude Medical MultiPoint Pacing clinical study. Twelve month results, consistent with the three month data, indicated a 19% increase in the number of patients responding to CRT compared to the standard-of-care, biventricular pacing.
Data presented at the 2014 Heart Rhythm Society’s (HRS) Annual Scientific Sessions in May, demonstrated an 18% reduction in mortality as well as other improved clinical outcomes and better cost utilization with St. Jude Medical’s quadripolar technology.
The company also presented additional data at HRS 2014, revealing that the use of its Quartet Quadripolar LV lead lowered hospitalization cases by 53% compared to patients in the non-quadripolar group. The lower hospitalization rate translated into a statistically significant 62% reduction in overall costs for both health care systems and patients.
Bottom Line
The large and growing body of clinical evidence combined with a strong product pipeline, including next-generation MultiPoint pacing (investigational device in the U.S.), makes St. Jude Medical’s quadripolar system the standard of care in improving the management of CRT.
Currently, St. Jude Medical carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the medical products industry include ICU Medical, Inc. (ICUI), Abaxis, Inc. (ABAX) and Neogen Corp. (NEOG). ICU Medical sports a Zacks Rank #1 (Strong Buy), while both Abaxis and Neogen carry a Zacks Rank #2 (Buy).
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