Business Wire

Study Finds 84% Survival Rate in Patients in Cardiogenic Shock and Other Challenging Cardiac Conditions with the New Impella 5.5 with SmartAssist

Share

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 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.

ABOUT ABIOMED

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.

FORWARD-LOOKING STATEMENTS

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.

Contact information

Sarah Karr
Communications Manager
978-882-8211
skarr@abiomed.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Ingenic Semiconductor Integrates Allegro DVT Encoding IP into Next-Generation Smart-Video System-On-Chip Solutions3.7.2020 12:46:00 CESTPress release

Allegro DVT, the leading provider of video semiconductor IP solutions, today announced that Ingenic Semiconductor, one of the leading system-on-chip companies in China has integrated the AL-E150 high-performance video encoding IP into its latest generation of Smart Video products. The Smart Video product family from Ingenic Semiconductor features highly integrated Video Processor system-on-chip (SoC) solutions targeted at various video applications such as consumer and professional video surveillance and battery-operated cameras. One of Ingenic latest video processors, includes Allegro DVT’s AL-E150 H.264/HEVC/JPEG encoder to handle compression of multiple video channels at resolutions up to 5Mpixels. This chip is now shipping in mass-volume. Brad Liu, VP of Smart Video BU, Ingenic commented, “With the AL-E150,Allegro DVT is able to offer a multi-format and feature-rich encoder IP which perfectly meets our requirements and represents the best trade-off between silicon area, high-video

Imaweb-IDF Group Completes Its Acquisition of Serinfer3.7.2020 11:16:00 CESTPress release

Imaweb/IDF Group (“The Group”), one of the largest developers of customer relationship management (“CRM”) solutions and dealership management systems (“DMS”) for the automotive industry in Europe, announced today that it has completed the acquisition of Serinfer Servicios Informáticos S.L. (“Serinfer”), the computer software segment of the Alvariño Group, a Spanish developer, distributor and supplier of DMS for automobile dealers. The Group is backed by Providence Strategic Growth (“PSG”), the growth equity affiliate of premier asset management firm Providence Equity Partners (“Providence”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200703005051/en/ Serinfer develops a range of sophisticated products to address the evolving needs of automobile dealers. Its flagship offering is SERAUTO, a complete DMS solution that works modularly and can also be integrated to the existing technology of any dealership or workshop. SERAUT

Taiwan’s COVID-19 response win applause, friendship from around the world3.7.2020 10:52:00 CESTPress release

Once considered the most vulnerable to the COVID-19 outbreak because it’s so close to China, Taiwan has turned out to be a model for the world’s fight against the pandemic, thanks to quick decisions and early measures by its government, and to the high standard of the island nation’s public health system and its people. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200703005042/en/ The management of Grand Hotel in Taipei asks its guests to help form Zero on the building’s facade to celebrate no new COVID-19 cases for the sixth day in a row on May 1, 2020. (Hsu Chao-chang, CNA) According to real-time data released on Worldometer (https://www.worldometers.info/coronavirus/), a website tracking global COVID-19 figures, as of June 30, Taiwan, with only 447 cases, ranked 155th among 215 countries in terms of the number of infections. Only three entities with fewer cases have a larger population than Taiwan’s, which currently sta

Northern Data announces new Block.one backed customer3.7.2020 08:27:00 CESTPress release

Northern Data AG (XETRA: NB2, ISIN: DE000A0SMU87), one of the world's largest providers of high-performance computing (HPC) solutions, continues to enjoy a very successful 2020 with the signing of 180 MW of capacity with a new customer. Northern Data's most recent customer is a Bitcoin mining operation backed by Blockchain Powerhouse Block.one with an initial 180 MW volume and an upsize option to 300 MW, which the company signed today and which shall go live in early 2021. Brendan Blumer, CEO of Block.one, says: "Block.one's focus on leveraging EOSIO to bring increased scalability and transparency to the greater blockchain industry led us to Northern Data and their strategic market positioning and strong leadership. We're excited to be collaborating with them to introduce unprecedented Bitcoin mining solutions, powered by EOSIO." Aroosh Thillainathan, CEO of Northern Data AG adds, "We are pleased that Block.one is convinced of our services and that we have won the company as another bl

ViiV Healthcare Announces US FDA Approval for Rukobia (fostemsavir), a First-in-Class Treatment for HIV in Adults With Few Treatment Options Available2.7.2020 22:39:00 CESTPress release

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets. Rukobia is a novel attachment inhibitor for the treatment of HIV-1 infection indicated for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection, who are failing their current ARV regimen due to resistance, intolerance or safety considerations. Significant advances over the past few decades have dramatically improved HIV treatment and for many, HIV is considered a manageable life-long condition. However, HTE adults – which account for approximately 6% of adults living with HIV who are on treatment – have little to no options left due to resistance, tolerability or safety considerations.1 HTE adults are at risk of progressing to AIDS and

Vertex Files Registration Statement for Proposed Initial Public Offering2.7.2020 22:31:00 CESTPress release

Vertex, Inc.,a leading provider of tax technology and services, today announced that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to a proposed initial public offering of its common stock. The number of shares to be offered and the price range for the proposed offering have not yet been determined. Vertex intends to list its common stock on the NASDAQ Global Market under the ticker symbol “VERX.” Goldman Sachs & Co. LLC and Morgan Stanley are acting as joint lead book-running managers and as representatives of the underwriters for the proposed offering. BofA Securities, Citigroup and Jefferies are also acting as book-running managers and JMP Securities, Stifel, William Blair and CastleOak Securities, L.P. are acting as co-managers for the proposed offering. The proposed offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus relating to these securities may be obtained