Business Wire

First 1,000 Patients Treated with Impella 5.5 with SmartAssist, a Heart Pump Designed for Surgeons

Share

Abiomed (NASDAQ: ABMD) announces 1,000 patients have been treated with the Impella 5.5 with SmartAssist heart pump in the first year after the U.S. Food and Drug Administration (FDA) granted Impella 5.5 with SmartAssist its highest level of approval for safety and efficacy.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201105005280/en/

The Impella 5.5 with SmartAssist heart pump helped Keith Brown, 64, recover from a heart attack. (Photo: Business Wire)

The Impella 5.5 with SmartAssist heart pump helped Keith Brown, 64, recover from a heart attack. (Photo: Business Wire)

In October 2019, the first U.S. patients were successfully treated by cardiac surgeons at Cleveland Clinic, Hackensack Meridian Health and Cedars-Sinai Medical Center. Since then, more than 120 hospitals in the U.S. and Europe have implanted the temporary heart pump.

The first 1,000 patients were treated primarily for cardiomyopathy, AMI cardiogenic shock, and post-cardiotomy cardiogenic shock, with an average duration of support of 14 days. (see figure 1) Uses of Impella 5.5 with SmartAssist include:

  • Escalating a patient’s care to a higher level of cardiac support
  • Providing bi-ventricular support, when used in combination with Impella RP
  • Unloading the left ventricle of patients on ECMO, a combination therapy known as ECpella

In July, a study published 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.

In August, the FDA granted Impella 5.5 with SmartAssist, and other left-side Impella heart pumps, an emergency use authorization (EUA) to treat certain patients with COVID-19 related complications who are undergoing ECMO treatment.

In October, the 2020 expert consensus from EACTS, ELSO, STS and AATS named Impella as a Class IIb recommendation as the primary or concomitant treatment option for post-cardiotomy cardiogenic shock with severe isolated left ventricular dysfunction. Impella is now recommended in 10 society clinical guidelines and consensus statements.

“We, as heart failure cardiologists and cardiac surgeons, are understanding the effectiveness of Impella 5.5 with SmartAssist as an unprecedented new option for cardiogenic shock patients as a bridge to recovery or bridge to next therapy,” said Shelley Hall, MD, chief, transplant cardiology, MCS and heart failure at Baylor Scott and White Dallas. “This fully unloading device allows us to treat hemodynamically challenged patients faster and easier with improved outcomes. The Impella 5.5 with SmartAssist is contributing to saving lives and giving these critically ill patients a chance at survival.”

One such patient is 64-year-old Keith Brown. After Keith collapsed and went into cardiac arrest, initial treatment methods weren’t effective. That’s when Michael Kwan, MD, and Masahiro Ono, MD, from Methodist Hospital in San Antonio, escalated Keith’s care and implanted Impella 5.5 with SmartAssist to provide maximum support and optimize the opportunity for Keith’s heart to recover.

Keith’s condition immediately began to improve, and he was able to walk around the hospital while on Impella support. The SmartAssist technology helped the physicians with patient management and assisted in weaning Keith off Impella after four days on support. Keith fully recovered and went home with his native heart. Today, Keith cares for his elderly father, enjoys time with his two children, and looks forward to traveling more with his wife.

“The Impella 5.5 with SmartAssist is a promising option for heart failure patients in cardiogenic shock,” said Mani Daneshmand, MD, director of heart & lung transplantation and mechanical circulatory support at Emory University Hospital. “A forward flow, minimally invasive heart pump gives surgeons an important new tool. With this heart pump, we have seen exceptional outcomes for our patients.”

“This heart pump is markedly improving the standard of care and enabling the management of higher risk cardiac surgery patients with a reduced left ventricular ejection fraction. It is incredible to have the opportunity to bring this advanced technology to our patients and see the improved outcomes firsthand,” said Raymond Lee, MD, a cardiothoracic surgeon at Providence Health in Santa Monica, California.

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 in the COVID-19 era
  • Ease of insertion, via the axillary artery or anterior 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

It is available in the U.S. and Europe for hospitals with established heart recovery protocols.

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.

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.

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.

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.

FORWARD-LOOKING STATEMENTS

Any 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.

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

Towerco Valocîme uses Sitetracker to gain operational efficiency and enable the more fair Towerco business model of Valocîme in France and Europe2.12.2020 08:00:00 CETPress release

Sitetracker, the global standard for managing high-volume projects for infrastructure owners and operators like Ericsson, British Telecom, Vertical Bridge, and Vodafone/Vantage Towers, is proud to announce their partnership with Towerco Valocîme, an innovative Tower company in France. The current distribution of the telecoms value chain is strongly unbalanced in favor of towercos. The purpose of Towerco Valocîme's offers is to rebalance in favor of owners and operators. At the end of 2019, more than 1,000 landlords had signed the Towerco Valocîme offers allowing them to increase their income significantly. In 2020, Towerco Valocîme has launched its operator offers to reduce their hosting costs and thus increase their average operating income per site. “We have created a fair and simple model for towers in France,” said Frédéric Zimer, CEO of Towerco Valocîme. He continued, “We have thousands of landlords and now we are bringing in operators. The key to maintaining our margins is operat

Deenova Bolsters Its 2020 Market Momentum in Pharmacy Automation With Entry Into Poland2.12.2020 08:00:00 CETPress release

Deenova announced today that in continuing its meteoric 2020 business boom, it made its first foray into Eastern Europe with new contracts for delivery of its market leading pharmacy robots and related technologies to Greater Poland Children's Health Centre in Poznań, with Polish leading equipment company MEDIM in Piaseczno. Piotr Młynarczyk, MEDIM General Manager, stated: “After a long search on a competitive sales process that thoroughly searched all options for pharmacy unit dose robots, I am very proud to select Deenova for partnership in the project at Greater Poland Children's Health Centre in Poznań. We chose Deenova solutions, mainly because of their unique technology and business approach to R.O.I.” Christophe Jaffuel, Deenova Chief Commercial Officer, added: “I am extremely excited to have been selected by Greater Poland Children's Health Centre in Poznań, and Poland medical technology leader MEDIM, especially after their extensive experience comparing and contrasting Deenova

Yokogawa and Power Factors Announce Reseller Agreement for Renewable Energy Asset Performance Management Platform2.12.2020 03:00:00 CETPress release

Yokogawa Electric Corporation (TOKYO: 6841) and US-based Power Factors, LLC, announce a global reseller agreement under which Yokogawa will market Power Factors’ industry-leading Drive software platform of asset performance management (APM) solutions for renewable power facilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201201005653/en/ Power Factor’s Drive platform for asset performance management (Graphic: Business Wire) Designed for solar, wind, and energy storage assets, Power Factors’ cloud-based Drive platform for APM delivers the tools and insights needed to optimize the levelized cost of energy (LCOE*) and address the complex integration of large, diverse fleets of renewable energy assets. The platform empowers owners and operators to overcome their biggest challenges, from dealing with aging control technology and disparate systems to the management of data quality, asset performance, and regulatory complian

LG Chem Life Sciences and TransThera Biosciences Announce FDA Clearance of IND for TT-01025, a SSAO/VAP-1 Inhibitor2.12.2020 00:00:00 CETPress release

LG Chem Life Sciences (“LG Chem”), a division of LG Chem, and TransThera Biosciences Co. Ltd. (“TransThera”), a clinical-stage biotechnology company based in Nanjing, China, announced today that U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for TT-01025, a novel SSAO/VAP-1 inhibitor for the treatment of non-alcoholic steatohepatitis (NASH) and other inflammatory diseases. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201201006171/en/ LG Chem will initiate the Phase 1 clinical trial at PPDLas Vegas Clinical Research Unit in Las Vegas, NV, United States to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TT-01025 in healthy subjects. The trial is expected to be initiated in the first quarter of 2021. “As liver manifestation of a metabolic disorder, NASH is a potentially life threatening condition which increases cardiovascular risk and can lead to

Anark Deepens Commitment to Customer Engagement with Additions to Executive Leadership Team, Marketing, and Sales Enablement1.12.2020 20:51:00 CETPress release

Anark Corporation, a leading provider of Intelligent Information Management (IIM) and collaboration software, announced today that Greg Caldwell, former marketing executive at 3D Systems and Microsoft, has joined as Vice President of Marketing and Sales Enablement. Caldwell will join the executive leadership team and be responsible for elevating Anark’s global brand, expanding market opportunity, and growing the business. Caldwell is a seasoned marketer, strategist, and business leader with an extensive background in IT hardware, software, and manufacturing. Throughout his career he has always believed in putting the customer first and creating modern, relevant, digital initiatives that help customers educate themselves and make more informed buying decisions. Prior to joining Anark in November of 2020, Caldwell was Vice President of Marketing and Communications at 3D Systems, one of the world’s leading additive manufacturing companies. Before 3D Systems, he spent almost 11 years as Gl

Lineage Logistics Enters the Polish Cold Storage Market With the Acquisition of Pago Sp. z o.o.1.12.2020 18:04:00 CETPress release

Lineage Logistics Holdings, LLC (“Lineage” or the “Company”), the world’s largest and most innovative temperature-controlled industrial REIT and logistics solutions provider, today announced it has acquired Pago Sp. z o.o. (“Pago”), a leading warehousing, distribution and transport logistics provider in Poland from its current ownership, including Tönnies International Holding GmbH (“Tönnies”). The strategic acquisition marks the Company’s entrance into the Polish market and adds six exceptional assets to Lineage’s global network of temperature-controlled facilities. Lineage was founded and continues to be managed by Bay Grove Capital, LLC (“Bay Grove”), a principal investment firm dedicated to partnering with strong management teams to build long-term platform investments. Financial terms of the transactions were not disclosed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201201005951/en/ The acquisition of Pago Sp. z o.o