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
VerSprite Launches Fork and Knife: AI-Driven Threat Modeling and Adversarial Testing Built for the Speed of Modern Software26.6.2026 23:28:00 CEST | Press release
Powered by the risk-centric PASTA methodology and two decades of accredited offensive security, the integrated platform lets enterprises threat model in a security sprint—then prove the risk through AI-led, human-on-the-loop testing. VerSprite, a global leader in risk-based threat modeling and the firm behind the PASTA (Process for Attack Simulation and Threat Analysis) methodology, today announced the general availability of Fork (www.forktm.com), a continuous application threat modeling platform, alongside Knife, an AI-led, human-on-the-loop adversarial testing platform for web applications and web API endpoints. Together, the two products operationalize a new model for product security—one where applications are securely designed, continuously modeled, and actively tested as part of the build process itself. The launch addresses a problem every security leader knows but few tools have solved: threat modeling is essential, never more so than in an AI-driven era, yet it has remained s
Venture Global Announces Closing of $1.5 Billion Senior Secured Vessel Financing Facility26.6.2026 22:30:00 CEST | Press release
Venture Global, Inc. (NYSE: VG) announced today that its wholly-owned subsidiary, Venture Global Shipping Holdings, LLC (“VGSH”), has entered into a Credit and Guaranty Agreement providing for a senior secured term loan facility (the “Facility”) in an aggregate principal amount of up to $1,500,000,000. The Facility will mature on June 26, 2032. Deutsche Bank and ING acted as coordinating lead arrangers for the Facility. ING also serves as facility agent and security trustee. VGSH intends to use the net proceeds from the Facility for general corporate purposes, including to reimburse Venture Global LNG, Inc. for payments previously made by it or its affiliates in connection with the acquisition of nine LNG carriers, funding certain reserve accounts, and paying transaction fees and expenses. About Venture Global Venture Global is an American producer and exporter of low-cost U.S. liquefied natural gas (“LNG”) with over 100 MTPA of capacity in production, construction, or development. Ven
Andersen Consulting tilføjer House of Code for at styrke teknologi- og dataløsninger26.6.2026 20:01:00 CEST | Pressemeddelelse
Andersen Consulting forstærker sine kompetencer inden for teknologisk transformation gennem en samarbejdsaftale med House of Code, en global virksomhed med hovedkvarter i USA, der specialiserer sig i datadrevne platforme, automatisering og agentbaserede ai-løsninger. House of Code blev stiftet i 2001 og udvikler softwareløsninger samt yder rådgivning til energihandels- og finanssektoren med kunder, der spænder over hedgefonde, kapitalfonde og forsyningsvirksomheder. Virksomheden besidder dyb ekspertise inden for energihandel og risikostyring og hjælper organisationer med systemimplementering, forretningstransformation, dataautomatisering og ai-underbygget modernisering af arbejdsgange. Deres proprietære platform, Enterprise Platform for Integrated Compliance (EPIC), skaber en mere effektiv datastyring, automatiserer rapporteringsprocesser, forbedrer den driftsmæssige gennemsigtighed på tværs af virksomhedssystemer og skaber et fundament for opbygning af intelligente, agentbaserede arbe
Capco Recognized by OpenAI for Innovation and Responsible AI Leadership26.6.2026 20:00:00 CEST | Press release
Receives AI Governance & Risk Excellence Award at OpenAI Partner SummitCapco’s UK AI Lab wins OpenAI Codex Hackathon Global management and technology consultancy Capco, a Wipro company,has been recognized by OpenAI for both AI innovation and responsible AI leadership. Capco received the AI Governance & Risk Excellence Award at the recent OpenAI Partner Summit 2026 in San Francisco, highlighting Capco’s ability to deliver enterprise-grade AI outcomes in highly regulated environments. The award recognizes Capco’s expert advantage when helping financial services and energy organizations to scale AI with confidence, balancing innovation with strong governance to reduce risk, strengthen compliance and improve customer outcomes. This award follows Capco winning the OpenAI Codex Hackathon, where its UK AI Lab competed against more than 30 teams and over 100 participants from across the OpenAI partner ecosystem. Capco's winning entry Sentra – a consulting-led, AI-powered retail banking solutio
Incyte Announces Positive CHMP Opinion for Opzelura® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis26.6.2026 13:30:00 CEST | Press release
If approved, Opzelura® (ruxolitinib) cream will be the first steroid-free, topical JAK treatment option in the European Union (EU) for adults with moderate atopic dermatitis (AD) for whom standard topical therapies have failedAD, the most common type of eczema which affects 230 million people globally,1 is a chronic, recurring, inflammatory and highly pruritic (itchy) skin condition that can have a significant impact on daily life2Phase 3 TRuE‑AD4 data supporting the positive CHMP opinion demonstrated that ruxolitinib cream met both co‑primary endpoints at Week 8, maintained disease control with as-needed treatment through Week 24 and was well tolerated3,4,5 Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids
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