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
Yubico Appoints Poupak Modirassari Enbom as Chief Marketing Officer to Accelerate Global Momentum and Drive Market Leadership30.3.2026 15:00:00 CEST | Press release
Yubico (NASDAQ STOCKHOLM: YUBICO), the creator of the most secure passkeys and a leading provider of hardware authentication security keys, today announced the appointment of Poupak Enbom as Chief Marketing Officer (CMO). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330278027/en/ Enbom joins Yubico at a pivotal moment as organizations worldwide accelerate the shift to phishing-resistant authentication and modern identity security in the age of AI. “We’re excited to welcome Poupak to Yubico,” said Jerrod Chong, acting chief executive officer, Yubico. “As the threat landscape evolves with AI-driven attacks and increasing automation, organizations are rethinking how they secure digital identities of both humans and AI agents at scale. She brings a unique combination of technical depth, global leadership, and customer-first mindset that will help us continue to expand our impact and support our customers and partners around
Westinghouse Celebrates Record-breaking 80 Years of Nuclear Fuel Manufacture at Springfields30.3.2026 14:00:00 CEST | Press release
Fuel manufactured at Springfields has generated enough energy to supply the UK’s electricity demand for 26 years, avoiding the emission of nearly 3 billion tonnes of CO2 The Westinghouse Springfields facility in Lancashire, UK, has marked a significant milestone as the oldest continuous nuclear fuel manufacturing site in the world, starting from its original license on the 28th, March 1946. The site was chosen by the UK Government to develop nuclear fuel for the world’s earliest civil nuclear power stations, as well as subsequent Magnox and Advanced Gas Reactors (AGR) reactors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330135973/en/ From left to right: Sophie Lemaire; Marc Chevrel; Rory O'Neill; Craig Boothby; and Robert Gofton, CEO at Nuclear Institute Across the last eight decades, the Springfields site has supported the UK nuclear fleet, manufacturing more than eight million AGR pins, sintering and pressing over 5
HistoSonics Treats First Patients Evaluating the Edison® Histotripsy System for the Treatment of Benign Prostatic Hyperplasia (BPH)30.3.2026 14:00:00 CEST | Press release
HistoSonics, the developer of the Edison® Histotripsy System and novel histotripsy therapy platform, today announced the successful treatments of the first patients in WOLVERINE, a prospective feasibility trial evaluating the Edison® Histotripsy System for the treatment of benign prostatic hyperplasia (BPH) at Prince of Wales Hospital in Hong Kong, a teaching hospital for The Chinese University of Hong Kong. The Edison System is a novel, non-invasive, image guided platform that uses the mechanical properties of focused ultrasound, called histotripsy, to destroy unwanted tissue without the need for invasive procedures, and with potentially fewer side effects than traditional, invasive therapies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330349844/en/ HistoSonics Non-Invasive Edison Histotripsy System. Image credit: HistoSonics WOLVERINE is a prospective, multi-center, single-arm feasibility trial designed to evaluate
Biocytogen Grants Taisho Pharmaceutical a License to its RenNano® Fully Human Heavy Chain-Only Antibody Discovery Platform30.3.2026 13:00:00 CEST | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that it has entered into a platform license agreement with Taisho Pharmaceutical Co., Ltd. (“Taisho”), granting Taisho the right to access and use Biocytogen’s proprietary RenNano® fully human heavy chain-only antibody (HCAbs) discovery platform for its internal research and development programs. Under the terms of the agreement, Taisho will leverage RenNano® mice to enable the generation and screening of fully human HCAbs in vivo and to support downstream research associated with antibody discovery. Financial terms of the agreement have not been disclosed. “We are very pleased to enter into this collaboration with Taisho,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “RenNano® is a robust and powerful fully human VHH discovery platform that pro
Meiji Seika Pharma Invests in Centivax to Develop Next Generation Universal Vaccine Platform30.3.2026 13:00:00 CEST | Press release
Meiji Seika Pharma Co., Ltd. (Head Office: Chuo-ku, Tokyo, President and Representative Director: Toshiaki Nagasato) today announced a strategic investment in Centivax, Inc. (Head Office: South San Francisco, CA, USA), a biotechnology company developing next-generation vaccines and therapies for universal protection against highly diverse targets. Centivax’s lead program includes a universal seasonal influenza vaccine (Centi-Flu 01) currently in a Phase 1 clinical study. Unlike conventional seasonal flu vaccines, which must be manufactured annually based on recommended candidate vaccine viruses, Centivax’s platform focuses both antibody and cellular immune responses on conserved regions of the influenza virus that cannot mutate and are shared across strains and distant subtypes. This approach aims to generate broad, consistent, and durable immunity against both seasonal and pandemic influenza. Meiji’s strategic investment aims to accelerate the advancement of Centi-Flu 01 and further a
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