ST. PAUL, Minn.–(BUSINESS WIRE)– St. Jude Medical, Inc., een internationaal bedrijf in medische apparatuur, heeft vandaag bekendgemaakt dat de Food and Drug Administration (FDA) zijn CRT-software heeft goedgekeurd. Deze software bouwt voort op de unieke MultiPoint ™ Pacing-technologie en is ontwikkeld om het portfolio voor cardiale resynchronisatietherapie (CRT) van St. Jude te optimaliseren. Het algoritme van SyncAC CRT is gemaakt om onafhankelijk of in samenhang met MultiPoint Pacing Technology te functioneren voor een effectieve behandeling van patiënten met hartfalen, van wie enkelen niet reageren op andere pacingbehandelingen.
SyncAV van St. Jude Medical, dat de pacing bij veranderingen van de cardiologische gesteldheid van de patiënt automatisch aanpast, stelt artsen tevens in staat de behandeling van patiënten die positief reageerden op traditionele CRT verder te verbeteren.
St. Jude Medical Continues to Expand its Heart Failure Portfolio in the U.S. to Provide Physicians Additional Options for Managing Patients Not Responding to Other Therapies
ST. PAUL, Minn.–(BUSINESS WIRE)– St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced Food and Drug Administration (FDA) approval and the launch of SyncAV ™ CRT software, designed to build upon the company’s first-to-market MultiPoint ™ Pacing technology and further optimize St. Jude Medical’s comprehensive cardiac resynchronization therapy (CRT) portfolio. The SyncAV CRT software algorithm is designed to function independently or in conjunction with MultiPoint Pacing Technology to address and effectively treat heart failure patients, some of whom are not responsive to other pacing options.
St. Jude Medical’s SyncAV technology, which automatically adjusts pacing based on real-time changes in a patient’s cardiac condition, also provides physicians the opportunity to further improve treatment of patients who have responded positively to traditional CRT. By allowing physicians to activate SyncAV CRT independently or with MPP technology, the software provides physicians additional options to individually optimize CRT settings for their heart failure patients, many of whom have resynchronization needs that can vary widely depending on their disease.
“The SyncAV software used alone or with MultiPoint Pacing technology offers the enhanced potential to optimize heart failure therapy for patients who previously did not respond to traditional CRT therapy,” said Dr. Adam Shapira, medical director of electrophysiology services at The Heart Hospital at Baylor, in Plano, Texas. “The SyncAV software also offers the ability for automated setup, which facilitates efficient programming both remotely via Merlin and directly in the office.”
For patients suffering from heart failure, CRT technology resynchronizes the lower chambers (ventricles) of the heart by sending uniquely programmed electrical impulses to stimulate each ventricle to beat in sync to offer improved cardiac performance. St. Jude Medical has introduced innovative solutions to enhance its CRT product portfolio to improve the care of the approximately 23 million people worldwide afflicted with congestive heart failure. While studies have shown that CRT can improve outcomes and the quality of life for many patients with heart failure, some patients do not respond optimally to traditional CRT, leaving physicians with limited options to improve their clinical outcomes for their patients. The latest heart failure offerings by St. Jude Medical will provide physicians and patients additional options that can help maximize the therapeutic effects of CRT.
“St. Jude Medical has a proven dedication to continued leadership in heart failure management to help physicians manage some of their most complex patients. Approval of the SyncAV CRT technology is important for those patients who are not getting the desired response from traditional cardiac resynchronization therapy,” said Dr. Mark Carlson, vice president of global clinical affairs and chief medical officer at St. Jude Medical.
Clinical Research at Scientific Sessions
Recent clinical research has helped confirm benefits to physicians deploying St. Jude Medical’s SyncAV CRT technology. New research presented at CARDIOSTIM-EHRA EUROPACE 2016 confirmed that optimized CRT settings can vary widely among patients, but that SyncAV can support the individualization needed to help physicians optimize electrical resynchronization.
In addition, investigational device exemption (IDE) clinical study results for MultiPoint Pacing technology were presented during a late-breaking clinical trial session at the Heart Rhythm Society’s 37 th Annual Scientific Sessions, as well as at this year’s annual CARDIOSTIM-EHRA EUROPACE 2016. The data showed the MPP IDE study met its primary endpoints of safety and efficacy, and additional analyses indicated a positive impact of MultiPoint Pacing programming on patient response to therapy. In addition, an Italian registry on multipoint left-ventricular pacing in CRT (IRON-MPP) was presented at the congress and also published in Europace. This study showed that compared with conventional CRT, MPP programming improved clinical status and increased ejection fraction in patients battling heart failure.
In total, more than 65 abstracts and publications to date have demonstrated that MPP can increase the number of patients who benefit from CRT therapy, including a study presented at the American College of Cardiology (ACC) 2016 meeting in Chicago, which demonstrated a 90 percent responder rate for patients at one year follow-up using MPP programming.
St. Jude Medical developed and launched the industry’s first quadripolar pacing system in 2009 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. St. Jude Medical launched the company’s proprietary, first-to-market MultiPoint Pacing technology in the United States in April 2016.
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. Study enrollment of over 1800 patients was completed earlier this year.
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 a comprehensive product portfolio that includes innovative, cost-effective solutions that help reduce hospitalizations and improve patient quality of life for heart failure patients around the world.
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.
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.