
Large Clinical Study Presented at STS 2021 Finds 79% Survival Rate with Impella 5.5 with SmartAssist
Abiomed (NASDAQ: ABMD) announces a large study of 356 patients treated with Impella 5.5 with SmartAssist at 16 U.S. and German centers found a 79% survival rate at explant. A majority of surviving patients recovered their native heart function without needing further mechanical support or a heart transplant.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210129005016/en/
Impella 5.5 with SmartAssist pulls blood from the left ventricle through an inlet area near the tip of the pump and expels blood through the catheter into the ascending aorta. (Graphic: Business Wire)
The study is the first large, multicenter experience examining survival rates with Impella 5.5 with SmartAssist support. It was presented at The Society of Thoracic Surgeons (STS) 2021 Annual Meeting by lead author Edward Soltesz, MD, MPH, a cardiovascular and heart transplant surgeon at Cleveland Clinic’s Miller Family Heart, Vascular & Thoracic Institute. The data was obtained from the Impella Quality (IQ) database and examined centers with ten or more patients treated with Impella 5.5 with SmartAssist.
The authors conclude Impella 5.5 with SmartAssist demonstrates successful clinical and device outcomes, including:
- 79% overall patient survival rate (n=301)
- 86% survival for cardiomyopathy cardiogenic shock patients (n=141)
- 67% survival for AMI cardiogenic shock patients (n=88)
- 68% survival for postcardiotomy cardiogenic shock patients (n=34)
“We were able to achieve a 79% overall survival rate by taking a novel approach in supporting these critically ill patients,” said Dr. Soltesz. “I am looking forward to seeing more prospective studies around this minimally invasive, high-flow temporary device.”
“This report demonstrates the benefit of the significant unloading with Impella 5.5 use in cardiogenic shock patients. We are impressed with the improved survival rates seen with Impella 5.5 use compared to traditional therapies,” said Scott Silvestry, MD, co-author of the study and surgical director of thoracic transplant, thoracic and cardiovascular surgery at AdventHealth in Orlando. “The use of best practices, techniques and this innovative new technology allows us to provide a better outlook to our patients.”
The STS study presentation provides additional evidence of improved outcomes with use of Impella 5.5 with SmartAssist. A study published in July in the American Society for Artificial Internal Organs (ASAIO) Journal found 84% survival to explant for Impella 5.5 with SmartAssist patients in cardiogenic shock and other challenging cardiac conditions. 76% of those patients achieved native heart recovery. 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.
In 2019, Impella 5.5 with SmartAssist received the U.S. Food and Drug Administration’s (FDA) highest level of approval for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. Impella 5.5 with SmartAssist delivers peak flows of greater than 6 liters per minute. Benefits of the Impella 5.5 with SmartAssist include:
- Impella Connect, providing cloud-based remote monitoring
- Ease of insertion, via the axillary artery or ascending aorta
- Designed for long-duration support, with patient ambulation, ceramic bearings and no pigtail
- Forward flow with maximum unloading, to provide end organ and coronary perfusion and allow the heart to rest
- Enables heart recovery, as a minimally invasive, weanable VAD
- Ease of patient management, can be intelligently positioned, weaned and managed with SmartAssist
In August, 2020, the FDA granted all left-sided Impella heart pumps, including Impella 5.5 with SmartAssist, an emergency use authorization (EUA) to treat certain patients with COVID-19-related complications who are undergoing extracorporeal membrane oxygenation (ECMO) treatment in the United States.
Attendees of STS 2021 are invited to attend two symposia related to Impella 5.5 with SmartAssist:
- Role of Surgeon: Managing the Shock Patient and Escalation, presented by Zain Khalpey, MD, PhD, from Northwest Medical Center in Tucson. This symposium will take place on Friday, January 29, from 3:30 – 4:00pm EST.
- Post Cardiotomy Cardiogenic Shock (PCCS): Is it Time for a New Strategy?, moderated by Scott Silvestry, MD, from AdventHealth Orlando and featuring a panel discussion with Zain Khalpey, MD, PhD, from Northwest Medical Center in Tucson, Masahiro Ono, MD, PhD, from Methodist Hospital in San Antonio, Danny Ramzy, MD, from Cedars-Sinai Medical Center in Los Angeles, and Deane Smith, MD, from NYU Langone Health in New York City. This symposium will take place on Sunday, January 31, from 7:30 – 8:30am EST.
ABOUT IMPELLA HEART PUMPS
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 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.
Impella Left Ventricular (LV) Support Systems are also authorized for emergency use by HCPs in the hospital setting for providing temporary (≤ 4 days for Impella 2.5, Impella CP, and Impella CP with SmartAssist; and ≤ 14 days for Impella 5.0 and Impella 5.5 with SmartAssist) LV unloading and support to treat critical care patients with confirmed COVID-19 infection who are undergoing ECMO treatment and who develop pulmonary edema while on V-A ECMO support or late cardiac decompensation from myocarditis while on V-V ECMO support. The authorized Impella LV Support Systems have neither been cleared or approved for the authorized indication for use. The Impella RP and Impella LV Support Systems have been authorized for the above emergency use by FDA under an EUA and have 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.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support and oxygenation. Our products are designed to enable the heart to rest by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. For additional information, please visit: www.abiomed.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. Forward-looking statements are subject to risks and uncertainties such as those described in Abiomed's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210129005016/en/
Contact information
Media Contact:
Sarah Karr
Communications Manager
978-882-8211
skarr@abiomed.com
Investor Contact:
Todd Trapp
Vice President and Chief Financial Officer
(978) 646-1680
ttrapp@abiomed.com
About 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.
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
H.I.G. Capital Announces the Sale of DGS S.p.A.11.6.2024 12:00:00 CEST | Press release
H.I.G. Capital (“H.I.G.”), a leading global alternative investment firm with $62 billion of capital under management, is pleased to announce that an affiliate has signed a definitive agreement to sell its portfolio company, DGS S.p.A. (“DGS” or the “Group”), a leading firm in the Italian Information Technology market, to DGS Co-Founders and management team in partnership with ICG, a global alternative asset manager. Since its inception in 1997, DGShas supported blue-chip customers in the design, integration, and maintenance of complex IT systems, with a specialization in digital transformation and cybersecurity services. The Group currently has over 1,900 employees, revenues of approximately €300 million, and maintains a group of highly loyal clientele. During H.I.G.’s ownership, DGS has tripled in size and consolidated its position as a leading Italian firm in cybersecurity services and digital transformation. DGS offers its clients sophisticated and proprietary digital transformation
Evertas Names Nick Selby Head of European Underwriting11.6.2024 12:00:00 CEST | Press release
Evertas, the world’s first crypto insurance company, has named Nick Selby as its new Head of European Underwriting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611141887/en/ Nick Selby, Executive Vice President and Head of European Underwriting at Evertas (Photo: Business Wire) Selby, an accomplished information and physical security professional, brings two decades of expertise in public and private sector information security, physical security, and complex incident handling, as well as seven years of experience leading teams securing billions of dollars in cryptoassets. Previously, his roles included VP of the Software Assurance Practice at Trail of Bits, Chief Security Officer at Paxos Trust Company, and Director of Cyber Intelligence and Investigations at the NYPD Intelligence Bureau. “Nick is an extremely valuable addition to our European team,” said Evertas CEO and Co-Founder J. Gdanski. “His public and private
Owlet utvider globalt fotavtrykk med lanseringen av medisinsk-sertifisert Dream Sock™ i Storbritannia og over hele Europa11.6.2024 11:00:00 CEST | Pressemelding
Owlet, Inc. («Owlet» or the «Company») (NYSE:OWLT), pioneren innen smart spedbarnsovervåking, kunngjør i dag den britiske og europeiske lanseringen av Dream Sock. Dette er en smart babymonitor med levende helseavlesninger og varsler for friske spedbarn mellom 0-18 måneder og 2,5-13,6 kg. Dette innovative medisinske utstyret gir foreldre helse og viktig informasjon i sanntid, noe som gir uovertruffen trygghet. Denne pressemeldingen inneholder multimedia. Se hele pressemeldingen her: https://www.businesswire.com/news/home/20240611820341/no/ (Photo: Business Wire) «Vi er svært stolte over å lansere Dream Sock til omsorgspersoner over hele Storbritannia og Europa og gi millioner av foreldre mer trygghet mens babyen sover,» sa Kurt Workman, Owlets administrerende direktør og medgründer. «Dream Sock er nå et globalt produkt som er anerkjent som medisinsk nøyaktig og trygt, etter å ha gjennomgått regulatoriske autorisasjoner og sertifiseringer innenfor flere geografier. I dag er misjonen vår
V-Nova Surpasses 1000 Patent Milestone in Media Technology Innovation11.6.2024 10:00:00 CEST | Press release
V-Nova, a leading provider of data compression solutions, video compression technology, XR technology, AI acceleration and parallel processing for a multitude of industries including media and entertainment, today announced its milestone achievement of 1000 active technology patents. This accomplishment underscores V-Nova’s dedication to research and development and its commitment to protecting its intellectual property globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611724561/en/ V-Nova’s patent portfolio spans more than 50 different jurisdictions. Including over 400 patents in Europe, over 200 in the Americas, over 100 in the United States specifically, and over 200 in Asia. V-Nova forged new directions in data processing to enhance digital experiences, maximize efficiency, reduce costs, and increase sustainability. The company leads the way with key international data compression standards for the video indust
Alipay+ Reveals Top Scorer Trophy Design for UEFA EURO 2024™11.6.2024 09:24:00 CEST | Press release
Alipay+, a suite of cross-border mobile payment and digitalization technology solutions operated by Ant International and an Official Partner of UEFA EURO 2024™, today revealed the trophy that will be awarded to the most prolific marksman at the UEFA EURO 2024™ finale on July 14 in Berlin, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240610328619/en/ The UEFA Top Scorer Trophy presented by Alipay+ is unveiled for UEFA EURO 2024™ (Photo: Business Wire) Sculpted in the shape of the Chinese character “支” (pronounced zhi, and meaning payment as well as support), the trophy reflects Alipay+’s dedication to supporting consumers to enjoy seamless payment and a broad choice of deals using their preferred payment methods while traveling abroad. The character also resembles the fleeting moment of a barefooted striker poised to shoot, evoking the original beauty and power of football – a game that united people across the wo