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
Axelspace: Notice of Signing a Service contract for In-Orbit Demonstration with Pale Blue, Inc.22.12.2025 10:00:00 CET | Press release
Axelspace Corporation (“Axelspace”), a leading microsatellite company committed to making “Space within Your Reach,” has entered into a service agreement with Pale Blue Inc. (“Pale Blue”), a company that develops, manufactures, and sells thrusters (engines) for small satellites, for an in-orbit demonstration, as detailed below. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251219321165/en/ Jun Asakawa, Co-founder & CEO of Pale Blue (left in photo) and Yuya Nakamura, President and CEO of Axelspace Axelspace provides AxelLiner Laboratory (AL Lab), a new service originating from the AxelLiner business that is specialized in in-orbit demonstration of space components. Under this contract, an in-orbit demonstration of a fast-start Hall thruster developed by Pale Blue is scheduled to be conducted in 2027. Nonetheless, conducting in-orbit demonstrations in a short period of time is known to be a significant challenge due to the in
Axelspace Signing Agreement on a Multi-Launch Arrangement and the Launch of New Satellites with Exolaunch22.12.2025 10:00:00 CET | Press release
Axelspace Corporation (“Axelspace”), a leading microsatellite company committed to making “Space within Your Reach,” is pleased to announce a multi-launch agreement (MLA) with Exolaunch, a global launch integrator and leader in launch mission management, satellite integration and satellite deployment technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251219038364/en/ The Multi-Launch Agreement will accelerate the growth of Axelspace. In particular, one satellite scheduled for launch under the new Agreement will be used in the AxelLiner business’s in-orbit demonstration service, “AxelLiner Laboratory”. Exolaunch has already secured launches for eight (8) Axelspace’s satellites on the upcoming missions. Axelspace provides AxelLiner Laboratory (AL Lab), a new service originating from the AxelLiner business that is specialized in in-orbit demonstration of space components. Nonetheless, conducting in-orbit demonstration
Zambon Biotech Announces First Patient Dosed in Phase 3b ADIP Clinical Study of IPX203 in Parkinson’s Disease22.12.2025 10:00:00 CET | Press release
Zambon Biotech, a specialized biotech company part of the Zambon group that aims to build a scientifically robust and commercially viable portfolio of innovative patient-oriented drugs through the scouting, acquisition, licensing and development of new molecules, today announced that the first participant with advanced Parkinson’s disease has been enrolled in the European Phase 3b ADIP (IPX203 in Advanced Parkinson’s disease) study, which is planned to evaluate the efficacy and safety of IPX203 versus immediate-release (IR) levodopa/carbidopa (LD/CD) in a regimen which has not yet been the focus of a Phase 3 trial. IPX203 is a novel, oral modified-release formulation of LD/CD designed for the treatment of Parkinson’s disease, the fastest growing neurological condition in the world according to the World Health Organization1. IPX203 contains immediate-release granules and extended-release beads, providing both a rapid onset of action and a longer duration of benefit, sustaining the levo
Pimicotinib Approved as Systemic Treatment in China for Tenosynovial Giant Cell Tumor22.12.2025 09:00:00 CET | Press release
First regulatory approval in the world for pimicotinib based on positive data from global Phase 3 MANEUVER studyIn MANEUVER, pimicotinib significantly improved objective response rate at week 25 (54% vs. 3.2% for placebo), while providing clinically meaningful and statistically significant improvements across all patient-reported outcomesWith longer-term follow-up, 3 out of 4 patients treated with pimicotinib achieved response per RECIST v1.1, and treatment continued to be well-toleratedApproval strengthens Merck’s leadership in rare tumors, with additional ongoing regulatory filings for pimicotinib underway globally Merck, a leading science and technology company, announced today that following Priority Review, the China National Medical Products Administration (NMPA) has approved pimicotinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause functional limitation or relatively severe morbidity.
Incyte Japan Announces Approval of Minjuvi® (tafasitamab) in Combination with Rituximab and Lenalidomide for the Treatment of Relapsed or Refractory Follicular Lymphoma22.12.2025 08:44:00 CET | Press release
Incyte Biosciences Japan G.K. today announced approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for Minjuvi® (tafasitamab) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL). “Today's approval of Minjuvi in combination with rituximab and lenalidomide marks a significant milestone as the first dual-targeted CD19 and CD20 immunotherapy combination for relapsed or refractory FL in Japan,” said Yasuyuki Ishida, General Manager, Incyte Biosciences Japan. “By improving progression-free survival, Minjuvi offers a chemotherapy-free option for eligible patients with relapsed or refractory disease. This approval underscores our commitment to bridging critical treatment gaps to patients and families affected by this challenging disease in Japan.” The approval is based on the pivotal Phase 3 inMIND trial, which enrolled 654 adult patients, including patients based in Japan. The study demonstrated that Minjuvi
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