MA-ABIOMED
5.12.2022 14:04:40 CET | Business Wire | Press release
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
Airship Announces Results Guarantee; Releases Commissioned Study Finding 476% ROI for Composite Organization22.7.2026 17:00:00 CEST | Press release
Airship stands behind results with new guarantee offer*; also launches a commissioned study quantifying how a composite organization moved past vanity metrics to drive $7.3M in value Airship, the mobile-first customer experience platform leader, today announced its Airship Results Guarantee, a corporate commitment to achieve predetermined business outcomes for new customers. Concurrently, the company released the results of a separate, commissioned Total Economic Impact™ (TEI) study conducted by Forrester Consulting on behalf of Airship, July 2026. The study found that a composite organization based on interviewed customers achieved a 476% Return on Investment (ROI) with a payback period of less than six months. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722832535/en/ Airship has launched a new results guarantee offer to stand behind its value. Alongside this offer, the team shared the results of a new Total Economic
Arrakis Comes out of Stealth With $38M to Help Industrial Enterprises Compete in the AI Era22.7.2026 15:56:00 CEST | Press release
Funding led by Blossom Capital with participation from Accel, GFC, MainObject, and Rerail, bringing total raised to around $38 million in just six months. Arrakis helps industrial companies deploy AI agents into mission-critical operations, tackling the "last mile" challenge that prevents most AI projects reaching production. The funding will enable office openings in New York and the Middle East, platform development and AI deployment in the world's most operationally complex industries. Arrakis, the AI deployment company helping industrial companies install AI agents for mission-critical operations, today announced a $30 million Series A led by Blossom Capital, with participation from existing investor Accel, which also led the company's $7.5 million seed round. The round brings total funding to around $38 million and includes backing from prominent technology leaders, including Olivier Pomel, founder and chief executive of Datadog, Olivier Godement, OpenAI’s Head of business product
Vultr and AMD Support the University of Cambridge's TESSERA AI Project to Accelerate Global Environmental Monitoring22.7.2026 15:00:00 CEST | Press release
Cambridge University's Energy & Environment Group Deploys Planetary-Scale Foundation Model on Vultr Cloud GPU Infrastructure Powered by AMD Instinct™ MI325X GPUs Vultr, the world’s largest privately-held cloud infrastructure company, and AMD, a leader in high-performance and AI computing, have announced their support for the University of Cambridge's Energy & Environment Group in developing TESSERA, a groundbreaking AI foundation model designed to monitor environmental change internationally at unprecedented scale. Vultr is providing the computational infrastructure, based on AMD Instinct MI325X accelerators, necessary to generate global embeddings covering Earth's land surface from 2017 to 2025, enabling applications in agriculture, biodiversity conservation, and renewable energy infrastructure monitoring. The collaboration represents a significant advancement in applying artificial intelligence to planetary conservation challenges. TESSERA processes data from European Space Agency Se
StructureCraft Scales Data-Driven Design on NetApp22.7.2026 14:00:00 CEST | Press release
Structural engineering firm modernizes data infrastructure to support global collaboration NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced that StructureCraft, an award-winning global structural engineering and construction firm known for complex timber and hybrid builds, is now using NetApp to modernize and create an AI-ready data infrastructure. The new infrastructure enables the company’s employees to collaborate globally, store and manage large-scale design workloads, and take advantage of AI-driven tools on a scalable, centralized platform. StructureCraft specializes in innovative timber engineering, structural design, and sustainable building solutions for large-scale architectural projects worldwide. Its globally distributed team delivers complex projects across North America, Europe, and Asia, guided by a core purpose to engineer and build beautiful, efficient structures. The StructureCraft team regularly takes on complex projects such as de
OneSpan Introduces DigipassONE, Bringing a Unified Platform Approach to Authentication Modernization22.7.2026 14:00:00 CEST | Press release
A new authentication platform helps financial institutions support diverse customer authentication preferences while modernizing at their own pace Organizations are under increasing pressure to modernize authentication while supporting existing infrastructure, meeting evolving regulatory requirements, deploying emerging technologies, and reducing operational complexity. For financial institutions in particular, authentication modernization must balance security, compliance, and operational efficiency while meeting the evolving expectations and preferences of their customers. Yet the journey to modern authentication is rarely a single technology transition. Organizations must continue supporting multiple authentication methods while gradually adopting new technologies, making it essential to modernize without disrupting existing environments, user experiences, or business operations. To help organizations navigate this transition, OneSpan Inc. (NASDAQ: OSPN) today announced DigipassONE™
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