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
Icon Solutions Appoints Raquel Guillot as Southern Europe Sales Director to Drive Global Adoption of the Icon Payments Framework29.10.2026 10:30:00 CET | Press release
Madrid-based appointment will focus on expanding the company’s presence across Southern Europe and developing opportunities in new markets Icon Solutions – the UK fintech enabling banks globally to design and implement state-of-the-art payment systems – has appointed Raquel Guillot as Southern Europe Sales Director, to drive adoption of the Icon Payments Framework (IPF) across the region. Guillot brings around 20 years of experience spanning banking, analytics, fraud prevention, payments and core banking technology. She began her career at Citibank before moving into financial technology, holding roles at SAS, ACI Worldwide and other technology providers, including Thought Machine. IPF is the internationally proven payments development framework trusted by banks across the globe, including Citi, UBS, NatWest and BNP Paribas. It enables banks to transform their systems in an accelerated, structured and low-risk way, all on their own terms. Based in Madrid, Guillot will focus on expandin
Alushibe Holding Group to Bring 12 Global F&B Brands to Libya by 202829.10.2026 09:00:00 CET | Press release
Ahmed Gadalla signs exclusive master franchise agreement with Türkiye's MADO: US$7 million, 7 cafés and 350 jobs in the first phase; 1,000 sq m Benghazi flagship opens Q1 2027 Alushibe Holding Group today announced plans to bring 12 international food-and-beverage brands to Libya by 2028 through its Retail & Destinations division, beginning with an exclusive master franchise agreement with MADO, the Turkish ice-cream and patisserie house founded in 1850. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261029822317/en/ Ahmed Gadalla signs exclusive master franchise agreement with Türkiye's MADO: US$7 million, 7 cafés and 350 jobs in the first phase; 1,000 sq m Benghazi flagship opens Q1 2027 – (Photo: AETOSWire) Signed in Kahramanmaraş on 13 October 2026 by Ahmed Gadalla, Founder and Chairman of Alushibe Holding Group, and Mehmet Sait Kanbur, Chairman of MADO, the agreement grants Alushibe exclusive rights to develop and opera
U.S. Bancorp Announces New U.S. Bancorp Global Funds Brand29.10.2026 09:00:00 CET | Press release
The platform also introduces its first offshore liquidity fund, domiciled in Ireland U.S. Bancorp today announced its new fund platform, U.S. Bancorp Global Funds, and its first offering, an offshore liquidity fund domiciled in Ireland, the U.S. Bancorp Liquidity – USD Treasury CNAV Fund. U.S. Bancorp Global Funds was created to support U.S. Bancorp’s growing international presence. It establishes a framework for future investment offerings and reflects U.S. Bancorp’s expanding presence in global markets. Investment products offered under the brand are established through U.S. Bancorp Global Funds ICAV, an Ireland-domiciled UCITS umbrella fund structure. The U.S. Bancorp Liquidity – USD Treasury CNAV Fund is the first offering introduced under the new brand. The U.S. Bancorp Liquidity – USD Treasury CNAV Fund is designed for investors outside the United States seeking to preserve capital while accessing a U.S. Treasury-focused liquidity solution within a regulated offshore structure. D
Element Biosciences Launches AVITI Dx™, Bringing CE-Marked IVD Sequencing to Ten EU Countries29.10.2026 09:00:00 CET | Press release
Integrated sequencing, reagents, and software bring IVDR-compliant sequencing capabilities to European clinical laboratories, with additional global markets planned to follow Element Biosciences, Inc. today announced the commercial launch of AVITI Dx, the company's first CE-marked in vitro diagnostic (IVD) sequencing platform under the European Union's In Vitro Diagnostic Regulation (EU IVDR). AVITI Dx integrates Element’s AVITI™ sequencing system, dedicated reagents, and software designed to meet applicable IVDR requirements and support regulated clinical laboratory workflows. The system is launching commercially in ten EU countries: the Netherlands, Germany, France, Italy, Spain, Austria, the Czech Republic, Latvia, Romania, and Poland, with additional markets planned through a phased approach. Developed and manufactured under Element's ISO 13485-certified quality management system, AVITI Dx is a Class A IVD sequencing system supported by IVDR-compliant reagents and software. Built o
Positively Languages Launches, Expands With Malta School and Opens New London Premises29.10.2026 09:00:00 CET | Press release
Positively Languages, a leading language learning business, is unveiling its new brand today. Formerly known as Kaplan Languages Group, (which Inspirit Capital acquired in May 2026), the business is also expanding its portfolio with the opening of a new school in Malta and a new premises in London. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261028449595/en/ Positively Languages, formerly known as Kaplan Languages Group, has taught English, French and German to more than one million students from 140 countries over the past 20 years. The new brand name ‘Positively Languages’ is built around the principle that ‘experience moves you forward’ which forms the backbone of the future growth of the business; new products based on experiences, new schools in the heart of key cultural cities. Positively Languages is also excited to announce the opening of a new school on the Mediterranean island of Malta, known as Positively Langu
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