Study Finds 84% Survival Rate in Patients in Cardiogenic Shock and Other Challenging Cardiac Conditions with the New Impella 5.5 with SmartAssist
The first published United States experience of patients who received Abiomed’s newest heart pump, Impella 5.5 with SmartAssist, finds 84% of the patients survived to explant with 76% native heart recovery. The study was published in the July edition of the American Society for Artificial Internal Organs (ASAIO) Journal.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200701005293/en/
The Impella 5.5 with SmartAssist is featured on the front cover of the July 2020 edition of the ASAIO Journal. (Photo: Business Wire)
The study examined the outcomes of the first 55 patients treated with Impella 5.5 with SmartAssist at Cleveland Clinic, Hackensack University Medical Center/Hackensack Meridian Health and Cedars-Sinai Medical Center. Study authors and cardiac surgeons Ed Soltesz, MD, Mark Anderson, MD, and Danny Ramzy, MD, conclude Impella 5.5 with SmartAssist is safe and effective for a number of challenging clinical scenarios, including AMI cardiogenic shock.
“This report demonstrates the benefit of unloading cardiogenic shock patients and it is encouraging to see real-world data demonstrate improved survival rates with use of Impella 5.5 with SmartAssist,” said Danny Ramzy, MD, assistant professor, surgical director of the lung transplant program, and director, robotic and minimally invasive cardiac surgery at Cedars-Sinai Medical Center. “The continued use of best practices, techniques and innovative technology like Impella allows us to provide better patient care that improves outcomes and quality of life.”
In September 2019, Impella 5.5 with SmartAssist received FDA pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. It is a micro-axial, surgically implanted, temporary heart pump that unloads the left ventricle, reduces ventricular work, and provides the circulatory support necessary to allow native heart recovery and early assessment of residual myocardial function. Its benefits include:
- Ease of insertion through the axillary artery or the anterior aorta
- Designed for long-duration support with durable ceramic bearings, no pigtail to minimize adhesions, and ability for patient ambulation
- Forward flow with maximum unloading, to provide end organ and coronary perfusion, while allowing the heart to rest
- Better patient management with intelligent device positioning, management, and weaning with SmartAssist technology
- Equipped with Impella Connect , a cloud-based monitoring and collaborative patient management platform that allows for remote monitoring of the Impella console. During the COVID-19 crisis, this online, HIPAA-compliant monitoring service is being provided at no cost to help medical providers manage patients 24/7.
The 55 patients in the study were implanted with Impella 5.5 with SmartAssist between October 16, 2019 and March 4, 2020. Specifically, the study authors determined:
- 35 patients (63.6%) were successfully weaned off the technology.
- 11 patients (20.0%) went on to receive another therapy, two patients (3.6%) expired while on support, and seven patients (12.7%) had care withdrawn.
- 76.1% of survivors recovered native heart function.
- There were no device-related strokes, hemolysis, or limb ischemia observed.
- The results demonstrate Impella provides dependable acute mechanical circulatory support for patients who need it by stabilizing their hemodynamics during treatment.
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 re-open 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 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
Matt Roney Named as Lumileds Chief Executive Officer21.9.2020 19:15:00 EEST | Press release
Lumileds, a global leader in innovative lighting solutions, today announced the appointment of Matt Roney as the company’s Chief Executive Officer, effective October 1, 2020. Roney most recently served as President of Lumileds’ Automotive Business Unit and succeeds Dr. Jonathan Rich who will continue with the company as Executive Chairman of the Board. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200921005130/en/ Matt Roney, CEO Lumileds (Photo: Business Wire) “Speaking on behalf of the Board of Directors, we are grateful for Jon’s contributions as CEO and believe Lumileds is well positioned for success in this next phase under Matt’s leadership,” said Rob Seminara, Senior Partner at Apollo Global Management. “Matt has nearly 25 years’ experience in the automotive industry and his performance and leadership throughout his career have given us even greater confidence in his ability to drive long-term innovation and growth a
Toshiba Information Systems (Japan) Integrates Verimatrix’s Whitebox Cryptographic Key Technology Into Customer’s Main Control Function to Safeguard Consumer Printers21.9.2020 18:45:00 EEST | Press release
Regulatory News: Verimatrix, (Paris:VMX) (Euronext Paris: VMX), the leader in powering the modern connected world with people-centered security, today announced that its value-added reseller, Japan-based Toshiba Information Systems (Japan) Corporation, has implemented Verimatrix Whitebox cryptographic key protection technology inside consumer printers produced by one of the country’s premier manufacturers. Whitebox is part of the Verimatrix Application Shielding family of solutions. "Exposed cryptographic keys are a significant vulnerability in IoT code for connected devices," said Asaf Ashkenazi, Chief Operating Officer at Verimatrix. "Our Whitebox tool allows Toshiba Information Systems (Japan) to dissolve keys into the code itself and obscures algorithms to keep its customer’s critical intellectual property, applications, devices and data safe. The deployment of our Whitebox technology into the devices of a leading electronics manufacturer illustrates our ability to easily empower p
RELX Outlines at the GTNF Role of Technology in Advancing Vaping Industry’s Responsible Practices21.9.2020 15:29:00 EEST | Press release
The company’s Global External Affairs Lead provided concrete examples of how RELX has been harnessing the power of technology, innovation and research in its quest to forge ahead robust youth prevention mechanisms. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200921005456/en/ Jonathan Ng speaking at the GTNF Innovations on the Horizon panel. (Photo: Business Wire) At the virtual Global Tobacco & Nicotine Forum (GTNF) event yesterday, RELX Technology’s Global Head of External Affairs Jonathan Ng spoke on a panel entitled “Innovations on the Horizon.” The panel explored several topics related to the growing international acceptance of e-cigarettes as better alternatives to cigarettes, innovations related to user experience and youth prevention, and illicit trade. GTNF is one of the leading tobacco and nicotine forums in the world; speakers and attendees include public health experts, government representatives, investors and
CHMP Grants Positive Opinion for Expanded Use of Otsuka’s Deltyba® (delamanid) in Children and Adolescents Weighing at Least 30kg Treated for Pulmonary Multi-drug Resistant Tuberculosis21.9.2020 14:12:00 EEST | Press release
Otsuka Novel Products GmbH (ONPG), a subsidiary of Otsuka Pharmaceutical Co., Ltd., is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends approval of extension of the indication for Deltyba® (delamanid) for children. This means Deltyba® (delamanid) is recommended by the CHMP for use as part of an appropriate combination regimen for pulmonary MDR-TB in adults, adolescents and children with a body weight of at least 30kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. According to the current World Health Organization Global TB Report, an estimated 1.1 million children (0-14 years of age) fell ill with TB in 2018.2 Each year, approximately 25,000-32,000 children fall ill with MDR-TB. Of these, only 3-4% are diagnosed and treated and consequently, approximately 21% of children with MDR-TB are likely to die.1 New global targets set at the UNs High Le
Visa Helps Prepare Small Businesses for the Holiday Buying Season as National Small Business Week Begins21.9.2020 14:00:00 EEST | Press release
As the Small Business Administration’s (SBA) National Small Business Week begins in the U.S. and businesses worldwide prepare for an unprecedented holiday season, Visa (NYSE: V) is introducing new programs and resources essential to small and micro business (SMB) recovery efforts. The Visa Back to Business Study, Holiday Edition, launched today, finds that consumers will carry their resolve for normalcy into the holiday shopping season, with 88% planning to buy and give gifts despite challenges the pandemic has created. To prepare for this unprecedented holiday season, SMBs should be looking for ways to offset the impact of COVID-19 during the holidays, with 60% already saying they are taking steps to prepare. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200921005150/en/ Visa’s Back to Business kits include new “tap to pay preferred” point-of-sale materials, branding, educational resources and special offers. (Photo: Busin
"If Agroaceite Grows, Our Communities Grow, Too"21.9.2020 14:00:00 EEST | Press release
This is one of our principles at Agroaceite, as pointed out by José Javier Aguirre, Corporate Director of the tropical oil company. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200921005269/en/ Agroaceite's Human Development Center facilities. "Some time ago I had the opportunity to visit Agroaceite ́s medical center, which is managed in collaboration with the University of Colorado. I was pleasantly impressed by the high quality service offered to the surrounding community. This is a good example of the kind of impact that RSPO certification aims to achieve: to improve people’s quality of life within the company ́s area of influence." FRANCISCO NARANJO, RSPO Representative for Latin America. (Photo: Business Wire) "Since Agroaceite was founded, the vision of social responsibility has been clear. Our main asset is our employees, and our best allies are the communities. As Agroaceite succeeds, communities must develop to th
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