MA-ABIOMED
Abiomed (Nasdaq: ABMD) announces the first three patients in the world have been treated with Impella RP Flex with SmartAssist, Abiomed’s newest heart pump for patients experiencing right heart failure. All three patients have now been successfully weaned off Impella support and two have already returned home with their native heart. The patients were treated at Hackensack University Medical Center/Hackensack Meridian Health in Hackensack, N.J., and Kingwood Medical Center in Kingwood, Texas.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221205005137/en/
Impella RP Flex with SmartAssist Illustration (Graphic: Business Wire)
Impella RP Flex is implanted percutaneously through the internal jugular (IJ) vein, which provides the option for patient mobility while on support, and is designed to be easy to implant, with a flexible canula that is advanced over an extra-supportive guidewire. It includes SmartAssist dual-sensor technology with Impella Connect, giving health care providers the ability to monitor the pump remotely from any internet-connected device and providing advanced metrics to help with pump management and weaning. It is also compatible with a sodium bicarbonate purge solution to simplify patient anticoagulation management.
“Impella RP Flex is an innovative technology that can allow right heart failure patients to be mobile while on support,” said Mark Anderson, MD, chairman of the department of cardiac surgery and a cardiothoracic surgeon at the Heart and Vascular Hospital at Hackensack University Medical Center/Hackensack Meridian Health, who led the medical team for the world’s first Impella RP Flex implant.
Dr. Anderson and his colleague Yuriy Dudiy, MD, implanted Impella RP Flex on a 71-year-old patient who was having a minimally invasive valve surgery. The patient received Impella RP Flex support for five days while their heart rested and recovered. Dr. Anderson’s second Impella RP Flex case involved a 51-year-old patient who experienced cardiac arrest and received Impella support for four days after valve surgery.
”Right ventricular failure is important to identify and treat early, and Impella RP Flex will enable more patients to achieve native heart recovery,” said Robert Salazar, MD, an interventional cardiologist and director of cardiovascular research at Kingwood Medical Center. Dr. Salazar and his colleague Marloe Prince, MD, implanted Impella RP Flex in a 75-year-old patient following a thrombectomy procedure for a pulmonary embolism. The patient remained on support for four days and is expected to be discharged from the hospital in the coming days.
Impella RP Flex is the latest iteration of the Impella RP heart pump. The U.S. Food and Drug Administration (FDA) granted Impella RP approval under a humanitarian device exemption (HDE) in 2015, followed by the pre-market approval (PMA), its highest level of approval as safe and effective in 2017. In October 2022, the FDA granted Impella RP Flex a PMA to treat acute right heart failure for up to 14 days and the first patients were treated in November 2022.
Also in October 2022, the FDA accepted and closed the Impella RP post-approval study, which enrolled 110 patients at 29 study sites. The study represented real world experience and identified the best practice of treating right heart failure early. Data published in the Journal of Heart and Lung Transplantation shows patients who received Impella RP support within 48 hours of cardiogenic shock onset had a significantly higher survival rate than those who received delayed right-heart support (72% vs. 14%, p<0.001, Anderson et al.).
Impella RP Flex is being introduced in the U.S. through a controlled rollout at leading centers for heart recovery.
ABOUT IMPELLA RP FLEX WITH SMARTASSIST
Impella RP Flex® with SmartAssist® is U.S. FDA approved to provide temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
ABOUT IMPELLA RP WITH SMARTASSIST
Impella RP® with SmartAssist 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.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed (Nasdaq: ABMD) is a leading provider of medical technology that provides circulatory support and oxygenation. Our products are designed to enable the heart to rest and recover by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. For additional information, please visit abiomed.com.
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.
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/20221205005137/en/
About Business Wire
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
Transition Industries and Mitsubishi Gas Chemical Sign Agreement for the Purchase and Sale of Ultra-Low Carbon Methanol6.11.2025 05:00:00 CET | Press release
Transition Industries LLC, a developer of world-scale, net-zero carbon emissions methanol and hydrogen projects, signed a long-term methanol sales and purchase agreement with Mitsubishi Gas Chemical Company, Inc. (MGC) for the offtake of ultra-low carbon methanol. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105695992/en/ Masahiko Naito, Division Director of Mitsubishi Gas Chemical and Rommel Gallo, CEO of Transition Industries sign agreement in Tokyo, November 6, 2025 Under the Agreement, which will become effective upon the Project’s Final Investment Decision (FID), Transition Industries will supply MGC approximately 1 million MT per annum of ultra-low carbon methanol from its Pacifico Mexinol project, a 6,130 MT per day methanol production facility near Topolobampo, Sinaloa, Mexico, expected to be in operation in 2029. Transition Industries is jointly developing Pacifico Mexinol with the International Finance Corpora
Kinaxis Announces Normal Course Issuer Bid5.11.2025 23:00:00 CET | Press release
Kinaxis® Inc. (“Kinaxis” or the “Company”) (TSX: KXS) is pleased to announce that the Toronto Stock Exchange (the “TSX”) has accepted a notice (the “Notice”) filed by the Company of its intention to make a normal course issuer bid (the “NCIB”). In connection with the NCIB, the Company has entered into an automatic share purchase plan (an “ASPP”) with its designated broker to allow for purchases of its common shares (the “Shares”). The Notice provides that the Company may, during the 12-month period commencing November 12, 2025 and ending November 11, 2026, or on such earlier date as Kinaxis completes its purchases or provides notice of termination, purchase up to 1,403,042 Shares in total, representing approximately 5% of the issued and outstanding Shares as at October 31, 2025. As of the close of business on October 31, 2025, the Company had 28,060,844 Shares issued and outstanding. Except for block purchases permitted under the rules of the TSX, the number of Shares to be purchased p
Hyper® Wins Dual CES 2026 Innovation Awards® for its Breakthrough Tech Accessories5.11.2025 22:45:00 CET | Press release
Hyper’s HyperSpace™ Trackpad Pro and HyperDrive® Next USB4 M.2 PCIe Enclosure named as CES Innovation Awards® 2026 Honorees Hyper®, a leader in mobile tech accessories for creators and power users, today announced it has been honored with two CES2026 Innovation Awards® in the Consumer Peripherals and Accessories category. These awards reflect Hyper’s mission to build breakthrough solutions that help users create, connect, and go beyond the limits of their devices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105297377/en/ CES Innovation Awards® 2026 Honorees: HyperSpace™ Trackpad Pro and HyperDrive® Next redefine haptics, personalization, and next-gen USB4 V2 speed. The CES Innovation Awards program is an annual competition that honors the most innovative, new products in consumer technology, recognizing top innovations across multiple categories. “For 20 years, Hyper has led the tech accessory space with industry-defin
CWAN Reports 800+ AI Agents Now Available for Deployment Across $10 Trillion in Client Assets5.11.2025 22:15:00 CET | Press release
Global institutions deploy CWAN GenAI agents that can scale to millions of daily tasks across reconciliation, reporting, and portfolio management Clearwater Analytics (NYSE: CWAN), the most comprehensive technology platform for investment management, today announced the global deployment of CWAN GenAI, a newly-launched, embedded generative AI platform that can be deployed to transform investment management, risk management, reporting and operations across more than $10 trillion in institutional assets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105092732/en/ What sets CWAN GenAI apart from the experimental AI tools flooding the market is its production-ready integration. Unlike copilots or chat tools layered onto legacy systems, CWAN GenAI is fully integrated and deployed into production on CWAN’s front-to-back platform, enabling clients to work alongside AI as collaborative partners in their investment operations. Th
IonQ and Swiss Consortium Launch First Citywide Dedicated Quantum Network in Geneva5.11.2025 22:04:00 CET | Press release
Landmark public-private initiative includes CERN, Rolex SA, Swiss government and academic institutionsDelivers world-class quantum infrastructure to support research, collaboration, and quantum tech awareness IonQ (NYSE: IONQ), the world’s leading quantum company, with luminary Swiss partners, successfully deployed a citywide quantum network in Geneva, Switzerland. This consortium of world-class academic, enterprise, and public institutions will advance quantum cybersecurity and communications research, collaboration, and innovation. The new infrastructure, named the Geneva Quantum Network (GQN), is the nation’s first dedicated quantum network connecting key institutions across the region. “Our involvement in the GQN alongside globally-renowned companies such as Rolex and research leaders like CERN, underscores our IP and pioneering leadership in quantum cybersecurity and communication,” said Niccolo de Masi, Chairman and CEO of IonQ. “IonQ is leveraging existing fiber optic infrastruc
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