Large Multi-Center Study in Japan Finds High Survival Rates with Use of Impella Heart Pump
A three-year, investigator-led, prospective study of Japanese patients who received an Impella heart pump finds use of Impella is associated with a 77% survival rate at 30 days in AMI cardiogenic shock patients. The historic survival rate for cardiogenic shock is approximately 50%. The study, conducted with oversight by 10 Japanese professional societies, including the Japanese Circulation Society (JCS), is the first to use the Japanese Registry for Percutaneous Ventricular Assist Devices (J-PVAD) to investigate the efficacy and safety of Impella. J-PVAD data is independently monitored and shared with the Japan Pharmaceuticals and Medical Devices Agency (PMDA). Lead investigator Yoshiki Sawa M.D., Ph.D., presented the interim analysis today as a late-breaking clinical study at the Annual Scientific Meeting of JCS.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200730005307/en/
Figure 1 (Graphic: Business Wire)
The interim analysis examined 819 patients treated with Impella for a variety of conditions, including cardiogenic shock and fulminant myocarditis, at 109 hospitals in Japan. Other findings include that Impella therapy is a highly effective treatment for fulminant myocarditis, with an 88% survival rate at 30 days. Overall, investigators conclude the favorable 30-day survival data indicates Impella is a beneficial therapy.
“This data demonstrates early use of Impella in drug-resistant acute heart failure patients can consistently achieve high rates of survival and native heart recovery for those in cardiogenic shock and other serious life-threatening conditions,” said Dr. Sawa, a professor at the Department of Cardiovascular Surgery at Osaka University Graduate School of Medicine and president of the Japanese Association of Thoracic Surgery. “This was accomplished by closely following best practices for Impella use. I thank my colleagues in the Japanese clinical community for following protocols and guidance from the Impella Committee to safely introduce a new therapy for the benefit of our patients.”
A previous analysis of cardiogenic shock survival rates in Japan by Ueki et al. (Circulation, 2015), found a 32% survival rate at 30 days in patients who received venous-arterial extracorporeal membrane oxygenation (V-A ECMO). The comparatively high survival rates with Impella were achieved by following established best practices that include placing Impella pre-PCI, identifying cardiogenic shock early, using a right heart catheter, and reducing use of inotropes. The study’s findings about the use of best practices are consistent with other published investigator-led studies, such as the National Cardiogenic Shock Initiative Study (NCSI) and the Inova study by Tehrani et al., that have demonstrated significant increases in survival with the use of Impella best practice protocols. (see figure 1)
“This encouraging study demonstrates, when known best practices are followed, significant improvements in cardiogenic shock survival rates can be achieved with use of Impella,” said William O’Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital and principal investigator of the NCSI Study. “I encourage physicians around the world to take note of the Japanese data, which demonstrates the rationale for early use of Impella in cardiogenic shock patients.”
In an online video, Dr. Sawa and Abiomed’s chief medical officer, Chuck Simonton, M.D., discuss how the use of Impella and best practices helped Japanese physicians achieve high survival rates. The video can be viewed at this link.
Native heart recovery with Impella is a cost-effective therapy of particular importance in Japan, a country with a limited number of heart transplants. The J-PVAD registry study is overseen by the Council for Clinical Use of Ventricular Assist Device Related Academic Societies (Japan VAD Council), Impella Committee, which is comprised of 10 organizations:
- The Japanese Circulation Society (JCS)
- Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT)
- Japanese College of Cardiology (JCC)
- The Japanese Heart Failure Society (JHFS)
- Japanese Society for Artificial Organs (JSAO)
- The Japanese Society of Intensive Care Medicine (JSICM)
- Japanese Society of Pediatric Cardiology and Cardiac Surgery (JSPCCS)
- The Japanese Association for Thoracic Surgery (JATS)
- The Japanese Society for Cardiovascular Surgery (JSCVS)
- Japanese Society of Percutaneous Cardiopulmonary Support / Extracorporeal Membrane Oxygenation (PCPS/ECMO)
The Impella heart pump is manufactured by Abiomed (NASDAQ: ABMD) and is the most studied mechanical circulatory support device in the history of the U.S. FDA with more than 14 years of FDA studies, real-world clinical data on more than 125,000 patients, and more than 650 peer-reviewed publications.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® devices are U.S. FDA PMA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to reopen blocked coronary arteries. The Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are U.S. FDA approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella RP® is U.S. FDA approved to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant or open-heart surgery. The Impella RP is also authorized for emergency use by healthcare providers (HCPs) in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m2, for the treatment of acute right heart failure or decompensation caused by complications related to coronavirus disease 2019 (COVID‐19), including pulmonary embolism (PE). The Impella RP has not been cleared or approved for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19. The Impella RP has been authorized for the above emergency use by FDA under an EUA and has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
In Japan, the Impella heart pump is used for the following indication: In the treatment of drug-resistant acute heart failure attributable to causes such as cardiogenic shock, a catheter is inserted percutaneously/transvascularly without chest-opening surgery, and blood is aspirated via the tip of a catheter inserted/placed into the left ventricle and pumped out via the outlet port located in the ascending aorta, thereby assisting with antegrade blood circulation in the body. It aims to improve hemodynamics and the recovery of the heart muscles through prompt assistance of antegrade blood flow in a minimally invasive manner while reducing burden on the heart muscles, allowing for prompt recovery of cardiac function.
In Europe, the Impella 2.5, Impella CP and Impella CP with SmartAssist are CE marked for treatment of high-risk PCI and AMI cardiogenic shock patients for up to 5 days. Impella 5.0 and Impella LD are CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 10 days. The Impella 5.5 with SmartAssist is CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 30 days. The Impella RP is CE marked to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, open-heart surgery, or refractory ventricular arrhythmia. To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit www.impella.com.
Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com. Abiomed, Impella, Impella 2.5, Impella 5.0, Impella 5.5, Impella LD, Impella CP, Impella RP, SmartAssist and Impella Connect are registered trademarks of Abiomed, Inc., and are registered in the U.S. and certain foreign countries. Impella BTR, Impella ECP, CVAD Study and STEMI DTU Study are pending trademarks of Abiomed, Inc.
This release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the company's progress toward commercial growth, and future opportunities and expected regulatory approvals. The company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic, development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the company's filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and the filings subsequently filed with or furnished to the SEC. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
GPD Companies, Inc. to Acquire Distrupol22.1.2021 16:33:00 EET | Press release
GPD Companies, Inc., an affiliate of One Rock Capital Partners, LLC (“One Rock”), today announced that it has entered into a definitive agreement to acquire Distrupol, a subsidiary of Univar Solutions Inc. (NYSE: UNVR) and a leading European distributor of thermoplastics to the polymer processing industry. Terms of the transaction, which is expected to close in the first half of 2021, were not disclosed. Headquartered in Surrey, England, with broad geographic reach across Europe, Distrupol has provided value-added sales and application development of thermoplastic resins for over 50 years. Through its decades-long relationships with world class supply partners, the company offers a robust array of superior performance products and solutions that meet the needs of diverse end users from leading and emerging industries, such as the consumer, medical, automotive, and electrical sectors, among others. Distrupol caters to over 1,300 customers across 13 countries with a portfolio of over 4,0
Schlumberger Announces Fourth-Quarter and Full-Year 2020 Results22.1.2021 14:50:00 EET | Press release
Schlumberger Limited (NYSE: SLB) today reported results for the fourth-quarter and full-year 2020. Fourth-Quarter Results (Stated in millions, except per share amounts) Three Months Ended Change Dec. 31, 2020 Sept. 30, 2020 Dec. 31, 2019 Sequential Year-on-year Revenue $5,532 $5,258 $8,228 5% -33% Income (loss) before taxes - GAAP basis $471 $(54) $452 n/m 4% Net income (loss) - GAAP basis $374 $(82) $333 n/m 12% Diluted EPS (loss per share) - GAAP basis $0.27 $(0.06) $0.24 n/m 12% Adjusted EBITDA* $1,112 $1,018 $1,648 9% -33% Adjusted EBITDA margin* 20.1% 19.4% 20.0% 73 bps 6 bps Pretax segment operating income* $654 $575 $1,006 14% -35% Pretax segment operating margin* 11.8% 10.9% 12.2% 90 bps -40 bps Net income, excluding charges & credits* $309 $228 $545 35% -43% Diluted EPS, excluding charges & credits* $0.22 $0.16 $0.39 37% -44% Revenue by Geography International $4,343 $4,210 $5,834 3% -26% North America 1,167 1,034 2,339 13% -50% Other 22 14 55 n/m n/m $5,532 $5,258 $8,228 5% -
JEOL: Release of a New Cold Field Emission Cryo-Electron Microscope CRYO ARM™ 300 II (JEM-3300)22.1.2021 09:00:00 EET | Press release
JEOL Ltd. (TOKYO:6951) (President & COO Izumi Oi) announces the release of a new cold field emission cryo-electron microscope (cryo-EM), the CRYO ARM™ 300 II (JEM-3300), to be released in January 2021. This new cryo-EM has been developed based on the concept of "Quick and easy to operate and get high-contrast and high-resolution images". This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210121005316/en/ Cold Field Emission Cryo-Electron Microscope CRYO ARM(TM) 300 II (JEM-3300) (Photo: Business Wire) Development Background Recent dramatic improvement of resolution in single particle analysis (SPA) using cryo-EM has led to SPA as an essential method for structural analysis of proteins. To address this market, JEOL released the CRYO ARM™ 300 in 2017. Equipped with a cold field emission gun (Cold FEG) for enhanced resolution and a cryo-stage for loading multiple samples, the CRYO ARM™ 300 has continued to achieve best-in-class res
ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment22.1.2021 01:12:00 EET | Press release
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults. Cabenuva is provided as a co-pack with two injectable medicines — ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine — dosed once monthly, as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.1 Lynn Baxter, Head of North America, ViiV H
Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)22.1.2021 00:30:00 EET | Press release
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The BLA submission is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, standard platinum-based chemotherapy. The trial enrolled 94 patients, including several with well-controlled human immunodeficiency virus (HIV) infection. The study, which was recently presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, resulted in an objective response rate (ORR) of 14% for retifanlimab monotherapy as determined by inde
Wistron and Kalray Announce FURIO1200™ Storage Appliance21.1.2021 19:45:00 EET | Press release
Wistron, a leader in ICT (Information and communications technology) products, and Kalray (Paris:ALKAL) (Euronext Growth Paris: ALKAL), a leading provider in new generation of processors specialized in Intelligent Data Processing from Cloud to Edge, announce the availability of FURIO1200™, a 24-Flash-Drive NVMe-oF based storage node appliance, integrating Kalray’s NVMe-oF K200™ smart storage adapter, powered by its MPPA® Coolidge™ intelligent processor, and Wistron LYMMA chassis. FURIO1200™ is a new type of hyper-fast disaggregated storage solution delivering ultra-high throughput and reliability. It is the ideal solution for Cloud Service Providers and Enterprises running applications with intensive AI and Data Analytics workloads as well as to optimize their next generation storage. Data Centers are undergoing a very important revolution due to the explosion of usages, the surge of data to be processed and the exponential growth of the number of machines to be managed to support this
NumAlim Selects Dawex and Orange Business Services for its Data and Services Exchange Platform21.1.2021 19:40:00 EET | Press release
NumAlim announced an agreement with Dawex, the leader in Data Exchange technology, and Orange Business Services, a network-native digital services company, to deploy its agri-food digital exchange platform. By relying on these two leading players, NumAlim chose secure technological solutions guaranteeing the sovereignty of French food data. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210121005722/en/ (Photo: Dawex) As early as Q1 2021, the NumAlim data and services exchange "Hub" will offer 18,000 companies in the food industry the opportunity to valorize, acquire and enrich all types of data: production, consumption, traceability, consumer opinions and research, as well as a wide range of services based on data (trend analysis, reformulation, regulatory watch…). "NumAlim is the answer to the needs for transparency, value creation and trust expressed by the food industry, consumers, and public authorities.” says Jérôme Fr
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom