St. Jude Medical HeartMate 3 LVAS Demonstrated Improved Clinical Outcomes for Patients Suffering from Advanced Heart Failure
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced results of the MOMENTUM 3 U.S. IDE Clinical Study during a late-breaking clinical trial session at the American Heart Association (AHA) Scientific Sessions in New Orleans. The MOMENTUM 3 study compared the HeartMate 3™ Left Ventricular Assist System (LVAS) to the HeartMate II™ LVAS in treating advanced stage heart failure and is the largest LVAD trial in the world to evaluate both short-term and long-term patients in a single study. The study results demonstrated patients receiving the HeartMate 3 LVAS had an 86.2 percent survival rate with freedom from disabling stroke and reoperation to repair or replace the device.
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20161116006280/en/
HeartMate 3 Left-ventricular Assist System (Photo: Business Wire)
The MOMENTUM 3 IDE study is a prospective, multi-center, randomized, unblinded, study evaluating the safety and effectiveness of the HeartMate 3 LVAS when used for the treatment of advanced, refractory, left ventricular heart failure. More than 1,000 patients with New York Heart Association (NYHA) Class IIIB or IV heart failure are participating in the study. Patients are being followed for a short-term endpoint of six months, and a long-term endpoint of two years. Current data show the results at the six-month follow-up in the first 294 patients enrolled.
The primary endpoint for the study was six months survival with freedom from disabling stroke and reoperation to repair or replace the device. The study met its primary endpoint (non-inferiority P<0.0001; superiority P=0.037). There were no pump thrombosis events reported in patients who were implanted with HeartMate 3 LVAS at six months, confirming the results observed with the HeartMate 3 LVAS in the CE Mark trial. Rates of all other adverse events were similar between the HeartMate 3 LVAS and historical rates seen in the HeartMate II LVAS, which is the most widely used and extensively studied LVAD commercially available. This study included all-comers, which means researchers evaluated the device regardless of whether the patient needed a short-term support option while awaiting transplantation or a long-term support option for those who are not candidates for cardiac transplantation.
“The Heartmate 3 LVAS improved clinical outcomes in the MOMENTUM 3 study by avoiding the need for surgical reoperation to replace or remove the pump due to pump thrombosis,” said Dr. Mandeep R. Mehra, medical director of Brigham and Women’s Hospital Heart and Vascular Center in Boston. “More importantly, these clinical gains occurred without an increase in other adverse events, providing important therapeutic progress for our advanced heart failure patients.”
The HeartMate 3 LVAS is a small, implantable mechanical circulatory support (MCS) device for advanced heart failure patients who are awaiting transplantation or are not candidates for heart transplantation. It is the first commercially approved (CE marked) LVAD with Full MagLev™ technology, designed to minimize complications and restore blood flow. The HeartMate 3 system utilizes Full MagLev technology, which allows the device’s rotor to be “suspended” by magnetic forces. This design aims to reduce trauma to blood passing through the pump and improve outcomes for patients.
“These data in the MOMENTUM 3 study represent the continued advancement in therapy options available for patients living with debilitating heart failure,” said Dr. John B. O’Connell, vice president and medical director for mechanical circulatory support at St. Jude Medical. “The HeartMate II LVAS is an extremely important medical advancement with more than 24,000 implants having occurred to date, and it is the only LVAD approved for both Bridge-to-Transplant and Destination Therapy options in the U.S. The data, now being seen with the HeartMate 3 LVAS, show that we are taking the next steps in advancing medical therapy options.”
Study Oversight Committee includes:
- Dr. Mandeep R. Mehra (Chair, Publication and Presentation Committee), Brigham and Women’s Hospital, Boston, MA
- Dr. Joseph Cleveland, University of Colorado, Denver, CO
- Dr. Daniel Goldstein, Montefiore Medical Center, NY, NY
- Dr. Nir Uriel, University of Chicago, Chicago, IL
The HeartMate 3 LVAS is CE Mark approved and limited by federal law to investigational use in the United States.
About Heart Failure
Heart failure is a widespread, chronic condition that develops when the heart muscle weakens and is unable to pump a sufficient amount of blood throughout the body. Heart failure worsens over time and is typically caused by persistent high blood pressure, heart attack, valve disease and other forms of heart disease or birth defects. Left untreated, the lack of adequate blood flow causes the organs to progressively fail, resulting in numerous medical complications that deteriorate a person’s quality of life.
According to the American Heart Association (AHA) and the Heart Failure Society of American (HFSA), about 6 million Americans are living with heart failure today, and 670,000 new cases are diagnosed each year. In the United States, the number of deaths from this condition has more than doubled since 1979.1
About the HeartMate 3 Left Ventricular Assist System
The HeartMate 3 LVAS includes a centrifugal blood pump that is implanted directly onto a patient's native heart and designed to supplement the pumping ability of the weakened heart's left ventricle, which is responsible for pumping oxygen-rich blood from the lungs throughout the body. The device is implanted above the diaphragm, immediately next to the native heart, and is attached to the aorta (the main artery that feeds blood into the entire body), leaving natural circulation in place while providing all of the energy necessary to propel blood throughout the body. The patient wears an external, wearable controller and battery system that powers the pump. The HeartMate 3 LVAS can pump up to 10 liters of blood per minute.
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, reimbursement strategies, 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 October 1, 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.
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
LIAF: Experts at the European Parlament - E-Cigarettes Are a Potential Game Changer for European Health20.3.2018 18:27 | Pressemelding
The following is a statement from LIAF – Lega Italiana Anti Fumo: The panel discussion at the EU Parliament recognises the potential benefits of electronic cigarettes and for European countries to treat these products as regular consumer products to ensure equal access for all Europeans. Following a debate in which leading scientific experts presented the state-of-the-art evidence around e-cigarettes, it became clear that public health is increasingly moving on from an approach that solely advocates ‘quit-or-die’ to a harm reduction strategy. “I’m glad to have brought the Parliament attention to this important issue for public health. Today we have listened to the results of scientific studies and researches from a high-level expert’s roundtable, which have illustrated to us the advantages of electronic cigarettes and the potential public health benefits that these products pose when compared to the conventional cigarettes. As decision-makers, we need to take into considerations these
Morinaga Milk's New Probiotic Strain, Bifidobacterium breve A1, May Prevent Onset of Alzheimer's Disease20.3.2018 18:00 | Pressemelding
Morinaga Milk Industry Co., Ltd. (TOKYO:2264), a leading Japanese dairy product company, today announced the results of a new study investigating the preventive effects of its new probiotic strain Bifidobacterium breve A1 on a model of Alzheimer’s disease. Researchers found that B. breve A1 improved spatial recognition capability, as well as learning and memory capabilities, in cognitively deficient mice, indicating it could play an important role in preventing the onset of Alzheimer’s Disease in humans.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180320005052/en/ (Fig. 1) Effects of B. Breve A1 in improving spatial recognition, learning and memory capabilities (Graphic: Business Wire) The number of patients affected by dementia is increasing worldwide. One report estimates there were 46.8 million people worldwide living with dementia in 2015 and projects this number will reach 131.5 million by 2050.2 Alzheimer’s disease
Dubai Breaks Ground on World’s Biggest CSP Project20.3.2018 16:10 | Pressemelding
HH Sheikh Mohammed bin Rashid Al Maktoum, Vice President and Prime Minister of the UAE and Ruler of Dubai, broke ground on the 4th phase of the Mohammed bin Rashid Al Maktoum Solar Park. This is the biggest Concentrated Solar Power (CSP) investment project in the world, based on the Independent Power Producer (IPP) model, and will generate 700MW on a single site. It will have the world’s tallest solar tower at 260 metres, and the largest thermal energy storage capacity in the world. It will provide clean energy to 270,000 residences, reducing 1.4 million tonnes of carbon emissions annually. The project will use two technologies: a 600MW parabolic basin complex and a 100MW solar tower, over 43 square kilometres. This project, with AED14.2 billion in investments, achieved the lowest Levelised Cost of Electricity (LCOE) of USD 7.3 cents per kW/h. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180320006214/en/ Dubai breaks groun
Edgecore Networks Introduces 400G Open Networking20.3.2018 16:00 | Pressemelding
OCP Summit – Edgecore Networks, the leader in open networking, today announced its contribution to the Open Compute Project (OCP) of the design of a 400 Gigabit Ethernet (400G) data center switch, the industry’s first 400G open design, that will enable public and private network operators to increase dramatically the capacity of their infrastructures. “Four years ago, Edgecore contributed the industry’s first OCP-ACCEPTED™ network product, a 10G top-of-rack switch,” said George Tchaparian, CEO, Edgecore Networks. “Since then, we have contributed over 15 network product designs as open networking technology and deployments grew to include 25G/100G data center fabrics, deep-buffer data center interconnect switches, service provider access infrastructures, open modular chassis, and campus/branch/wireless networks. Now, Edgecore is introducing the industry’s first 400G open network switch, enabling network operators to respond to growing demands for network capacity, and increasing the ban
Technics Organizes World's First Full Turntable Orchestra20.3.2018 14:48 | Pressemelding
On March 20, 2018, the "Record Day," Panasonic Corporation released the video of the world's first full orchestra performance featuring Technics "turntables (analog record players)" as the only instruments, under the Technics brand's theme, "Rediscover Music." This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180320006023/en/ World's First Full Turntable Orchestra organized by Technics (Photo: Business Wire) Videos: - THE PHILHARMONIC TURNTABLE ORCHESTRA https://youtu.be/JGWuyMKT8wU - BEHIND THE BEATS : THE PHILHARMONIC TURNTABLE ORCHESTRA https://youtu.be/J2KK3vqJqog "The Philharmonic Turntable Orchestra" special website Thirty renowned DJs from around the world, including DJ Rena, the reigning Japanese world champion (youngest ever world champion in history), who took the "DMC World Championship" title in 2017 at just 12 years old*, came together to create the world's first "turntable orchestra." Using the Technics' iconic tu
Bentley Systems' Year in Infrastructure 2018 Conference and Awards Gala to be Held in London, Oct. 15-1820.3.2018 14:30 | Pressemelding
Bentley Systems, Incorporated, a leading global provider of comprehensive software solutions for advancing infrastructure, today announced that the Year in Infrastructure 2018 Conference will be held Oct. 15 through 18 in London at the Hilton London Metropole. Presented by Bentley Institute, the conference is a global gathering of leading industry executives and prominent thought leaders in the design, construction, and operations of the world’s infrastructure. The theme of this year’s conference is Going Digital: Advancements in Infrastructure. The conference features nearly 70 speakers and more than 50 informative sessions, including keynotes by leading industry experts, interactive workshops, forums, panel discussions, and product demonstrations. Attendees can visit the Technology Pavilion, which features exhibits and presentations from Bentley Systems and its strategic partners Microsoft, Siemens, Topcon, and Bureau Veritas. On the first day of the conference, Bentley Institute wil