St. Jude Medical Announces MultiPoint Pacing IDE Study Results During Late-Breaker at Heart Rhythm 2016
ST. PAUL, Minn. & SAN FRANCISCO--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced presentation of the MultiPoint Pacing (MPP) Investigational device exemption (IDE) Clinical Study results during a late-breaking clinical trial session at the Heart Rhythm Society's (HRS) 37th annual scientific sessions. The MultiPoint™ Pacing technology, featured on the Quadra Assura MP™ cardiac resynchronization therapy defibrillator (CRT-D) and the Quadra Allure MP™ CRT-pacemaker (CRT-P), recently received Food and Drug Administration (FDA) approval and launched in markets throughout the U.S. The study met its primary endpoints of safety and efficacy, and additional analyses indicated a positive impact of MPP programming on patient response to therapy. The company’s proprietary, first-to-market MultiPoint Pacing technology is a revolutionary approach designed for cardiac resynchronization therapy (CRT) patients who are not responsive to other pacing options, as well as providing opportunity for further improvement in patients who are responders to traditional CRT.
“Due to the complex nature of their cardiac disease and electrical conduction patterns, it is not possible to determine which of our heart failure patients will be non-responders to traditional cardiac resynchronization therapy. The MultiPoint Pacing technology provides additional options for treating these difficult to manage patients and as this study shows, we continue to learn more about which program settings are most effective,” said Dr. Gery Tomassoni, primary investigator of this study and director of electrophysiology at Baptist Health Lexington in Lexington, Kentucky.
Despite the improvements in patient outcomes seen with quadripolar CRT technology, a significant proportion of patients do not respond to resynchronization therapy. Importantly, these “non-responders” to CRT cannot be identified at the time of implant; thus, the extent to which the therapy is effective for an individual patient is difficult to predict. MultiPoint Pacing technology offers physicians a new set of tools that allow for individualized patient therapy with the goal of optimizing their response to CRT.
The St. Jude Medical MPP IDE study was a prospective, multi-center, randomized, double-blinded non-inferiority clinical study including more than 500 patients at 49 centers who were all implanted with a quadripolar pacing device. In the first three months of the trial, all patients received biventricular pacing. Thereafter, patients were randomized to either standard biventricular pacing or MPP programming for an additional six months of follow-up. Those first three months without MPP programming turned on allowed the investigators to determine the patient’s response or non-response to CRT. Patients’ responder status was assessed at three and nine months using theClinical Composite Score (CCS).
The primary safety endpoint was met with a 93.2 percent freedom from system-related complications. The primary efficacy endpoint was met by demonstrating non-inferiority of response rate in the MPP technology group compared to the biventricular pacing group at nine months compared to three months. Additional analyses demonstrated the ability of MPP technology to achieve an 87 percent response rate in patients with optimal program settings. These data further support previously reported studies, including one presented at last month’s American College of Cardiology (ACC) meeting in Chicago, which demonstrated a 90 percent responder rate for patients at one year follow-up using MPP programming compared to traditional methods of CRT.
“We know that up to one-third of patients do not respond to traditional cardiac resynchronization therapy. A growing body of clinical evidence, including data from this IDE study, shows that MultiPoint Pacing can enhance the response to CRT for heart failure patients whose devices are appropriately programmed,” said Dr. Mark Carlson, vice president of global clinical affairs and chief medical officer at St. Jude Medical. “We will continue to study and improve the response of cardiac resynchronization therapy and look forward to the results of our MORE CRT-MPP study that just completed enrollment.”
Cardiac resynchronization therapy includes a lead (Quartet™ Quadripolar LV Lead) placed on the lower left chamber of the heart (ventricle). The left ventricle pumps oxygenated blood from the heart out to the rest of the body. MultiPoint Pacing technology is designed to deliver electrical pulses to multiple locations on the Quartet lead to make the heart’s lower chambers pump in a more coordinated way to mirror the natural contractions of a healthy heart. More than 60 abstracts and publications demonstrate that this increases the number of patients who benefit from this type of therapy (CRT).
Approximately 23 million people worldwide are afflicted with congestive heart failure and 2 million new cases are diagnosed worldwide each year. Studies have shown that CRT can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. The CRT technology resynchronizes the lower chambers (ventricles) of the heart by sending uniquely programmed electrical impulses to stimulate each ventricle to beat in sync for optimal cardiac performance.
St. Jude Medical developed and launched the industry’s first quadripolar pacing system in the United States in 2011 featuring four pacing electrodes, offering physicians the ability to effectively and efficiently manage the ever-changing needs of patients with heart failure. The Quartet LV lead design allows the physician to implant the lead in the most stable position without making trade-offs in electrical performance; this has also been demonstrated to reduce the likelihood of costly and invasive lead revision through a second intervention procedure.
The St. Jude Medical MORE CRT MPP clinical study is designed to demonstrate the benefits of the St. Jude Medical MultiPoint Pacing technology in improving patient response to CRT therapy.
About St. Jude Medical’s Heart Failure Business
St. Jude Medical is pioneering heart failure disease management with innovative solutions like the CardioMEMS™ HF System, ground-breaking quadripolar technology and, in select European markets, the HeartMate 3™ left ventricular assist system and our first-to-market MultiPoint pacing technology. St. Jude Medical collaborates with heart failure specialists, clinicians and advocacy partners to provide innovative, cost-effective solutions that help reduce hospitalizations and improve patient quality of life for heart failure patients around the world.
For more information about St. Jude Medical’s focus on heart failure, visit the St. Jude Medical Heart Failure Media Kit or the St. Jude Medical PULSE Blog.
Information for patients to learn more about heart failure can be found at www.heartfailureanswers.com.
About St. Jude Medical
St. Jude Medical is a leading global medical device manufacturer and is dedicated to transforming the treatment of some of the world's most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 18,000 people worldwide and has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management and cardiovascular. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended January 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 2, 2016. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.