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
SINOVAC Announces Record and Distribution Dates for Special Cash Dividend30.4.2025 08:00:00 CEST | Press release
Sinovac Biotech Ltd. (NASDAQ: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that a special dividend of US$55.00 per common share, as previously announced on April 1, 2025, will be paid in cash to valid holders of SINOVAC’s common shares as of the close of business on May 23, 2025, ET. Such cash dividend is expected to be paid on or about July 9, 2025. About SINOVAC Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases. SINOVAC’s product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected hand-foot-mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, etc. The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalificat
SES: Q1 2025 Results30.4.2025 07:30:00 CEST | Press release
Solid Start to the Year SES S.A. announces financial results for the three months ended 31 March 2025. Revenue of €509 million (-0.5% yoy(1)) and Adjusted EBITDA(2) of €280 million (-0.9% yoy(1)), both growing excl. periodic impact Networks revenue up +8.4% yoy(1) including some periodic impact supported by growth in Government (+13.1% yoy(1)) and Mobility (+8.5% yoy(1)); Media (-10.6% yoy(1)) in-line with expectations €360 million of new business and contract renewals signed in Q1 2025 Net Leverage at 1.2x(3) (including cash & cash equivalents of €3.1 billion(4)) O3b mPOWER satellites 7&8 have reached final orbital position – boosting mPower network capacity and resilience from May FY 2025 financial outlook(5) on track with yoy stable Revenue and broadly stable Adjusted EBITDA re-affirmed Fully funded Intelsat acquisition anticipated to complete in H2 2025 – intention to optimise the combined debt structure On 3 April 2025, AGM approved all company recommended resolutions including pr
Geoswift Launches Visa Direct to Enhance Cross-Border Payment Offers in Over 30 Countries30.4.2025 03:00:00 CEST | Press release
Geoswift announced today the integration of Visa Direct with Geoswift's cross-border payments platform. Visa Direct facilitates payouts to more than 140 countries and territories. The integration will enable payouts in 32 countries and territories, across 13 currencies, covering major markets in Asia Pacific, North America, Europe and Middle East, with plans for more in the future. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250423288249/en/ Bryan Ma, SVP, Head of Geoswift Global Payments, and Swapnil Mhasde, Head of Visa Direct Commercialization and Solutions, Asia Pacific, celebrating the launch in Singapore. Geoswift is a leading provider of cross-border payment services and solutions globally. With over two decades of innovation, it has become a trusted name in B2B, education, eCommerce, remittance, and travel payment use cases. Raymond Qu, Group CEO of Geoswift, stated, "At Geoswift, our vision has always been to del
Logitech Announces Q4 and Full Fiscal Year 2025 Results29.4.2025 22:03:00 CEST | Press release
A Year of Broad-Based Sales Growth, Expanded Market Share and Increased Profitability, Driven by Strategic Priorities SIX Swiss Exchange Ad hoc announcement pursuant to Art. 53 LR — Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the fourth quarter and full Fiscal Year 2025 ended March 31, 2025. For Fiscal Year 2025: Sales were $4.55 billion, up 6 percent in US dollars and 7 percent in constant currency, compared to the prior year. GAAP operating income was $655 million, up 11 percent compared to the prior year. Non-GAAP operating income was $775 million, up 11 percent compared to the prior year. GAAP earnings per share (EPS) was $4.13, up 7 percent compared to the prior year. Non-GAAP EPS was $4.84, up 14 percent compared to the prior year. Cash flow from operations was $843 million. The year-ending cash balance was $1.5 billion. The Company returned $797 million of cash to shareholders through its annual dividend payment and share repurchases.
U.S. Patent and Trademark Office Invalidates Pharmacyclics Patent Asserted Against BeiGene29.4.2025 21:32:00 CEST | Press release
BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced that the U.S. Patent and Trademark Office (USPTO) rendered a Final Written Decision invalidating all claims of Pharmacyclics LLC’s (Pharmacyclics) U.S. Patent No. 11,672,803 (the ‘803 patent) that were challenged by BeiGene in a post-grant review (PGR) proceeding. On November 1, 2023, BeiGene filed a PGR petition with the USPTO challenging the validity of certain claims of the ‘803 patent, in response to a patent infringement lawsuit Pharmacyclics brought against BeiGene concerning BRUKINSA® (zanubrutinib). On May 1, 2024, the USPTO granted BeiGene’s petition to institute the PGR. The USPTO’s Final Written Decision is appealable by Pharmacyclics. Commenting on the ruling, BeiGene General Counsel Chan Lee said: “We are pleased that the USPTO invalidated all challenged claims of the ‘803 patent. Today’s decision reinforces our belief th
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