ST. PAUL, Minn.–(BUSINESS WIRE)– St. Jude Medical, Inc., internationaal producent van medische apparatuur, heeft vandaag bekendgemaakt dat de Food and Drug Administration (FDA) zijn MultiPoint™ Pacing-technologie heeft goedgekeurd. Deze voor de markt unieke techniek is bedoeld voor de Quadra Allure MP-defibrillator voor resynchronisatietherapie, de Quadra Allure MP™ CRT-pacemaker en twee nieuwe, vierpolige Quartet™ LV-geleidingsdraden. MultiPoint Pacing maakt een revolutionaire aanpak mogelijk en biedt extra opties, die voordelen opleveren voor CRT-patiënten die niet reageren op andere pace-methodes. De goedkeuring is een belangrijke eerste stap in de uitrol van MultiPoint Pacing-technologie en de beschikbaarheid daarvan in de eerste helft van dit jaar.
Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, welke als enige rechtsgeldig is.
Source: St. Jude Medical, Inc.
View this news release and multimedia online at:
St. Jude Medical Receives FDA Approval for Industry’s First MultiPoint Pacing Technology
ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval of the first-to-market MultiPoint™ Pacing technology featured on the Quadra Assura MP™cardiac resynchronization therapy defibrillator (CRT-D), the Quadra Allure MP™ CRT-pacemaker (CRT-P) and two new quadripolar Quartet™ LV leads. MultiPoint Pacing technology enables a revolutionary approach and provides additional options, which may benefit CRT patients who are not responsive to other pacing alternatives. This approval is an important first step in the rollout of MultiPoint Pacing technology, and availability to U.S. physicians is expected in the first half of this year.
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. CRT 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.
Despite the improvements seen with quadripolar CRT technology, non-responders to therapy remain a significant issue. Also, non-responders to CRT are not able to be identified at the time of implant and individual patient response can be unpredictable.
Previous studies have shown that activating more ventricular tissue faster may enhance heart muscle performance. MultiPoint Pacing technology allows physicians the opportunity to capture more left ventricular tissue quickly by delivering pacing pulses to multiple left ventricle locations rather than the traditional single pulse for each heartbeat. Using the Quartet™ LV lead with its four uniquely spaced electrodes, physicians now have the capability to program two pulses from a single lead and tailor them to the specific needs of each patient.
“Having the ability to truly individualize cardiac resynchronization therapy is a significant step forward in the clinical approach to treating some of our most complex heart failure patients,” said Dr. Gery Tomassoni, director of electrophysiology at Baptist Health Lexington in Lexington, Kentucky. “MultiPoint Pacing technology provides a new set of tools that can be non-invasively programmed in an attempt to improve CRT response, thus opening up an important new treatment option for many patients who may need it.”
St. Jude Medical also announced FDA approval of additional quadripolar pacing Quartet LV leads, which can be used with MultiPoint Pacing technology, as well as the programmer-based Auto VectSelect Quartet™ Test. The two new leads are designed based on the company’s first-to-market, clinically proven Quadripolar LV lead technology and include additional electrode spacing options on two new S-curve shaped lead designs. The expanded family of Quartet LV leads offers more options to effectively meet the needs of patients with larger as well as smaller cardiac anatomies. Physicians can quickly customize therapy using the new automated Auto VectSelect Quartet Test, which is designed to offer comprehensive testing results so appropriate therapy options can be easily and efficiently programmed for each patient in a streamlined workflow.
“Continuing our quadripolar leadership, MultiPoint Pacing represents our commitment to invest and innovate in state of the art heart failure treatment options,” said Philip Ebeling, vice president and chief technology officer for St. Jude Medical. “These additions to our comprehensive CRT portfolio are examples of St. Jude Medical’s focus on providing physicians with technologies that result in effective patient outcomes and transform the treatment of some of the world’s most expensive epidemic diseases.”
St. Jude Medical developed and launched the industry’s first quadripolar pacing system in the U.S. 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 also has been demonstrated to reduce the likelihood of costly and invasive lead revision through a second intervention procedure. MultiPoint Pacing technology shifts the treatment options from a single point of pacing to multiple quadripolar pacing offerings that provide physicians more advanced options to optimize CRT performance.
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, our first-to-market MultiPoint™ Pacing technology and, in select European markets, the HeartMate 3™left ventricular assist system. 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.
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 has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management, and cardiovascular diseases. 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 3, 2015 and Quarterly Report on Form 10-Q for the fiscal quarter ended October 3, 2015. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Check out our twitter: @NewsNovumpr