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
Alipay and Singapore Tourism Board join hands to boost Chinese tourist spending16.7.2018 02:00 | Pressemelding
Alipay, the world’s leading mobile and online payment and lifestyle platform operated by Ant Financial Services Group, together with the Singapore Tourism Board (STB), have launched a series of joint marketing initiatives aimed at raising destination awareness of Singapore and driving tourist spending among Chinese visitors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180715005021/en/ Alipay and STB signed a Memorandum of Understanding (MOU) in September 2017 to enhance Chinese tourists’ overall experience in Singapore. Under the MOU, both parties agreed, among other things, to explore co-investing in joint-marketing initiatives to encourage Chinese tourists to spend with Alipay while in Singapore. Since signing the MOU, Alipay has experienced double-digit growth in user spending. China has also become Singapore’s top market in 2017 for both tourism receipts and visitor arrivals, contributing S$4.2 billion in tourism rece
Koza Altin Welcomes Court’s Rejection of Akin Ipek’s Share Purchase Agreement13.7.2018 15:58 | Pressemelding
A Turkish Court has found against businessman Akin Ipek this week – ruling that a share purchase agreement, which he had submitted as vital evidence in support of his case against the Turkish state, is null and void. The matter was brought to the Ankara Commercial Court in March 2017 by Koza Holding (parent company of Koza Altin) which, according to Mr Ipek’s share purchase agreement, purportedly transferred all of its shares to Ipek Investment Limited. Koza Holding filed the lawsuit for legal recognition that the share purchase agreement is void. The ruling in Turkey follows on from an earlier judgment set down by the English High Court, which rejected Mr Ipek’s attempt to use up to £3m of UK subsidiary Koza Ltd’s money to fund a claim against the Turkish State at the International Centre for Settlement of Investment Disputes (ICSID). In the English ruling, Deputy Judge Richard Spearman QC declared the “authenticity” of the share purchase agreement as “open to very serious doubt”. The
Mindbreeze Positioned in the Leaders Quadrant of the Gartner’s 2018 Magic Quadrant for Insight Engines13.7.2018 15:27 | Pressemelding
Mindbreeze, a leading global provider of appliances and cloud services for information insight and applied artificial intelligence with a focus on knowledge management for leading international companies, announced today that Gartner, Inc. has positioned Mindbreeze in the Leaders quadrant of the 2018 Magic Quadrant for Insight Engines. Mindbreeze is positioned highest on the ability to execute axis. The research and advisory firm Gartner, Inc. evaluated 13 different providers from all over the world. “Understanding the meaning of information is a key priority for today’s customers. Mindbreeze InSpire leverages the full power of our sophisticated AI engine to provide actionable insights and answers ̶ not just more data. Seeing our position in the Magic Quadrant, my first reaction was ‘AWESOME’. Insight Engine was positioned the highest on the ability to execute axis and we believe that's exactly what sets us apart from our competitors. We made the bold move to focus on product innovatio
H.I.G. Capital Announces the Sale of Kondor13.7.2018 14:06 | Pressemelding
H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €20 billion of equity capital under management, announced today that one of its affiliates has sold Kondor Limited, a specialist provider of category management solutions for audio and mobile accessory products into the retail and mobile network channels in the UK and Europe, to DCC Technology (which principally trades under the Exertis brand), part of DCC plc, the leading international sales, marketing and support services group. Terms of the transaction were not disclosed. Headquartered in Dorset, England, Kondor distributes audio and mobile accessory products to a broad range of e-tail, retail and mobile operator customers. H.I.G. invested in Kondor in 2014, and has since overseen a full reorganisation of the business. H.I.G. worked in partnership with Kondor to professionalise back office systems, develop Kondor’s access to market data, optimise the company’s product range, improve stock manag
Contactless Technology Powers Fifty Percent of Purchases at 2018 FIFA World Cup Russia™13.7.2018 09:00 | Pressemelding
Visa (NYSE: V), the Official Payment Services Partner of FIFA, today released an analysis of spending inside the 2018 FIFA World Cup Russia™ stadiums from the opening match on June 14 through the semi-finals on July 11. The data highlights the increased consumer adoption of innovative payment technology, as fifty percent of purchases with Visa in tournament venues utilized contactless transactions, including cards, mobile devices and wearables. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180713005025/en/ For the 2018 FIFA World Cup Russia™, Visa is the exclusive payment service in all stadiums where payment cards are accepted. In-stadium, fans can pay with contactless Visa credit and debit cards and mobile payment services at the more than 3,500 point-of-sale terminals and 1,000 mobile concessionaires that have been equipped with the latest in payment innovation. (Photo: Business Wire) Visa cardholders on average spent 1,
Brazil Approves AerSafe for Airbus 321 Aircraft to Comply with Fuel Tank Flammability Reduction Rule12.7.2018 19:18 | Pressemelding
AerSale ® announced today that the National Civil Aviation Agency of Brazil (ANAC) has approved the Federal Aviation Administration’s (FAA’s) Supplemental Type Certificate (STC) for the company’s AerSafe™ system on Airbus 321 aircraft (ST04010NY), that complies with the Fuel Tank Flammability Reduction (FTFR) rule. This is the second ANAC STC approval for AerSafe, following approval on Boeing 737 CL aircraft in 2017. In the coming months, AerSafe will be expanded to cover additional aircraft types, to meet the September 2019 deadline of the ANAC regulation, Regulamento Brasileiro da Avaiação Civil (RBAC) nº 121.1117, that applies specifically to passenger aircraft that fly within or into Brazil. AerSale’s STCs for the Boeing 737 CL and NG series (ST02980NY) and Boeing 767 series (ST03599NY) have already been approved by the FAA. “We are pleased that our Latin American customers operating A320 family aircraft are now able to immediately benefit from AerSafe’s numerous advantages,” said