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
Andersen Consulting tilføjer samarbejdsfirmaet TechSparq25.10.2026 06:09:00 CET | Pressemeddelelse
Andersen Consulting udvider sine kompetencer inden for teknologi og forretningstransformation gennem en samarbejdsaftale med TechSparq, en amerikansk virksomhed, der kombinerer strategi, commerce engineering og ai med praktisk implementering. TechSparq er et digitalt konsulenthus, der tilbyder strategi- og rådgivningstjenester, commerce engineering samt tjenester inden for ai og agentbaseret handel til virksomheder inden for detailhandel og forbrugsgoder, luksus og mode samt e-handel og direkte salg til forbrugere. Virksomheden har hovedkontor i Oregon og kombinerer strategisk planlægning med praktisk implementering for at hjælpe kunderne med at udvikle deres digitale initiativer, kundeoplevelse og driftsmodeller. "Vi etablerede vores virksomhed for at bygge bro mellem dem, der udvikler strategien, og dem, der har ansvaret for at føre den ud i livet," udtalte Dedrick Boyd, stifter af og administrerende direktør for TechSparq. "Vores samarbejde med Andersen Consulting giver os mulighed
BeOne Presents Compelling Data in Hard-to-Treat Liver and Lung Cancers at ESMO 202624.10.2026 10:15:00 CEST | Press release
Potential first-in-class GPC3 x 4-1BB bispecific achieves a 36% confirmed response rate at Phase 3 dose and favorable safety profile in heavily pretreated liver cancerBrain-penetrant PRMT5 inhibitor shows promising antitumor and CNS activity in the largest publicly shared MTAP-deficient datasetFirst clinical data of CEA-targeting ADC demonstrates encouraging and sustained responses in CEAhigh NSCLC BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new data from multiple differentiated investigational medicines across its priority solid tumor disease areas at the European Society for Medical Oncology (ESMO) Congress 2026 (October 23–27, Madrid). The presentations span gastrointestinal, lung, and breast cancers, and reflect the growing momentum of BeOne’s solid tumor franchise. Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne, said: “At ESMO, we are showing how our strategy of matching the right modality to dise
Phase 3 RAINIER Results Supporting Best-in-Class Potential of Povetacicept in IgA Nephropathy Published in the New England Journal of Medicine and Presented at the American Society of Nephrology Kidney Week 202623.10.2026 19:42:00 CEST | Press release
- Vertex is on track for the U.S. FDA Prescription Drug User Fee Act (PDUFA) date of November 30 for potential accelerated approval of povetacicept –- Data published in NEJM and presented at ASN highlight povetacicept’s unique trifecta of efficacy, favorable safety, and the simplicity of dosing at-home every 4 weeks with a low-volume autoinjector –- Data presented at ASN include a qualitative study examining patient perspectives on current and emerging IgAN therapies, showing that 96% of participants preferred an autoinjector over a prefilled syringe, and 80% of participants preferred dosing every 4 weeks versus weekly dosing - - New clinical studies of povetacicept underway including a study evaluating patient experience on povetacicept administered via autoinjector - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the publication of Phase 3 RAINIER results for povetacicept in the New England Journal of Medicine (NEJM), presentation of these data at the American Soc
BeOne Medicines Reports Sustained Survival Benefit with TEVIMBRA-ZIIHERA Combination in First-Line HER2+ Gastroesophageal Cancer23.10.2026 16:15:00 CEST | Press release
New data from HERIZON-GEA-01 Phase 3 trial show 36-month overall survival of nearly 40% with TEVIMBRA plus ZIIHERA and chemotherapy, and median OS reaching 27 monthsTEVIMBRA-containing arm was associated with a four-month longer median OS compared with ZIIHERA plus chemotherapy BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new survival results from the planned second interim analysis (IA2) and final formal analysis of the Phase 3 HERIZON-GEA-01 trial, further confirming the benefit of TEVIMBRA® (tislelizumab) plus ZIIHERA® (zanidatamab) and chemotherapy as first-line treatment for patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). The results will be presented today as a late-breaking abstract during a rapid oral session at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain (LBA79). Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne,
Lifezone Metals Confirms Advanced Negotiations with Orion CMC on Kabanga Nickel Project23.10.2026 16:10:00 CEST | Press release
Lifezone Metals Limited (NYSE: LZM) notes comments made today by Oskar Lewnowski, Founder and Group Chief Executive of Orion Resource Partners, in an interview with Bloomberg Television regarding the Company’s Kabanga Nickel Project in Tanzania. In response to inbound inquiries from media outlets and investors following the interview, the Company can confirm that negotiations with Orion Critical Mineral Consortium (Orion CMC) regarding a significant equity investment into the Kabanga Nickel Project are at an advanced stage. The Orion CMC is a global investment platform launched by Orion Resource Partners in partnership with the U.S. International Development Finance Corporation (DFC) and Abu Dhabi's sovereign investor ADQ. As previously announced, the Company has been running a competitive process, led by Standard Chartered Bank, to secure a strategic investment into the Kabanga Nickel Project. Social Media LinkedIn | X | YouTube About Lifezone Metals Lifezone Metals (NYSE: LZM) is com
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