Impella RP Flex with SmartAssist Receives FDA Approval to Treat Right Heart Failure
Abiomed (Nasdaq: ABMD) announces that Impella RP Flex with SmartAssist has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA), the FDA’s highest level of approval, as safe and effective to treat acute right heart failure for up to 14 days. Impella RP Flex is implanted via the internal jugular (IJ) vein, which enables patient mobility, and has dual-sensor technology designed to optimize patient management.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221031005234/en/
Impella RP Flex with SmartAssist (Photo: Business Wire)
The Impella RP platform includes the world’s smallest percutaneous right heart mechanical circulatory support (MCS) technologies designed to help patients achieve native heart recovery. They do not require extracorporeal blood circulation and remain the only MCS technologies with FDA PMA indications for the treatment of right heart failure.
Key clinical benefits of Impella RP Flex include:
- Single venous access via the internal jugular (IJ) vein and 11 French (Fr) indwelling catheter, facilitating patient mobility
- Flexible cannula advanced over an extra-support guidewire, enabling ease of insertion and pump delivery
- SmartAssist dual-sensor technology with Impella Connect, providing advanced metrics to help with pump management and weaning
- Heparin-free purge, simplifying patient anticoagulant management with the use of sodium bicarbonate where heparin is of concern due to heparin intolerance or bleeding
“Impella RP Flex demonstrates Abiomed’s ongoing commitment to improving patient survival and achieving native heart recovery,” said Mark B. Anderson, MD, chairman of the department of cardiac surgery and cardiothoracic surgeon at the Heart and Vascular Hospital at HUMC/Hackensack Meridian Health.
Early identification of right heart failure or right ventricular dysfunction and early use of Impella RP is associated with significantly higher survival rates. Studies published in the Journal of Cardiac Failure and Journal of American College of Cardiology demonstrate that 37% of AMI cardiogenic shock (AMICS) patients exhibit right heart dysfunction (Lala et al.) and that right heart dysfunction is associated with three times increased risk of mortality (Mehta et al.). 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 (73% vs. 14%, p<0.001, Anderson et al.).
“The complexity of right ventricular failure has resulted in patients being underdiagnosed and undertreated,” said Robert Salazar, MD, an interventional cardiologist and director of cardiovascular research at Kingwood Medical Center. “Impella RP Flex is a novel tool that gives physicians the flexibility to treat this challenging patient population.”
The FDA indication for use of Impella RP Flex with SmartAssist is as follows:
The Impella RP Flex with SmartAssist System is indicated for providing 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.
Impella RP Flex will be introduced in the U.S. through a controlled rollout this quarter.
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/20221031005234/en/
Contact information
Media:
Jenny Leary
Associate Director, U.S. Communications
+1 (978) 882-8491
jleary@abiomed.com
Investor:
Todd Trapp
Executive Vice President and Chief Financial Officer
+1 (978) 646-1680
ttrapp@abiomed.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
A-CAP Announces Successful Divestiture of Standard de Liège SA and Immobilière du Standard de Liège SRL6.6.2025 23:32:00 EEST | Press release
Advantage Capital Holdings, LLC (“A-CAP” or “The Company”), a New York-based insurance and financial services company with over $12 billion in assets, today announced the successful divestiture of Standard de Liège SA (“Standard Liège” or the “Club”), one of Belgium's most historic soccer clubs, and Immobilière du Standard de Liège SRL, the corporate entity that owns the Club's stadium, Maurice Dufrasne Stadium, to a consortium of buyers led by Standard Liège Chief Executive Officer Giacomo Angelini. This transaction marks the end of 777 Partners’ legacy involvement with the Club and sets the stage for the Club’s future growth and success, both on and off the field. Benefits of the transaction include: Increased stability across the Club’s shareholder base, which clears the path for future investments, Operational clarity, establishing a unified direction that will allow both players and management to fully concentrate on on-field performance, ensuring that collective focus remains on
Populous Acquires Fentress Architects, Expanding Global Aviation Portfolio6.6.2025 21:00:00 EEST | Press release
Populous, the world-renowned design firm specializing in sport and entertainment venues, today announced the acquisition of Denver-based Fentress Architects, a global leader in iconic aviation projects and prominent public buildings, including convention centers, museums and government facilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250606849000/en/ Los Angeles International Airport. Designed by Fentress Architects. This strategic acquisition unites two of the most respected names in architecture, combining Populous’ unparalleled expertise in designing memorable experiences with Fentress’ award-winning portfolio of aviation, civic and cultural landmarks. The acquisition significantly broadens the scope and scale of services that Populous can offer clients across the globe. Bruce Miller, Populous Global Chair and CEO, commented: “We are committed to expanding the breadth of our practice. Fentress Architects has lon
Vertex Presents New Data on Benefits of ALYFTREK ® and Importance of Achieving Lower Sweat Chloride Levels at the European Cystic Fibrosis Conference6.6.2025 19:00:00 EEST | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data across multiple studies demonstrating positive clinical and quality of life benefits of treatment with CFTR modulators and, in particular, ALYFTREK® (vanzacaftor/tezacaftor/deutivacaftor), which is approved in the United States and United Kingdom and is currently under review with health authorities in the EU, Canada, Australia, New Zealand and Switzerland. These data were presented at this year’s European Cystic Fibrosis Society’s (ECFS) 48th European Cystic Fibrosis Conference held June 4-7, 2025, in Milan, Italy. During the conference, the Company presented data from a pooled analysis across CFTR modulators, including ALYFTREK, which demonstrate that reduction in sweat chloride (SwCl), and therefore greater restoration of CFTR function, is associated with improved outcomes in people with cystic fibrosis (CF). For all clinical outcomes in the study, SwCl levels below 60 mmol/L were associated with greater benefit
IBSA Derma at IMCAS Asia 2025: spotlight on the future of aesthetic medicine in the 10 th Anniversary Year of NAHYCO ® Technology6.6.2025 17:00:00 EEST | Press release
IBSA Derma – the dermoaesthetic division of IBSA – once again confirms its leadership in the international aesthetic medicine landscape by participating in the 18th edition of IMCAS Asia, taking place from June 6 to 8 in Bangkok, Thailand. With over 3,000 attendees expected, the event represents a key opportunity for physicians and experts to share the latest innovations and cutting-edge advancements in aesthetic procedures and treatments, staying at the forefront of this dynamic field. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250603094257/en/ IBSA’s stand at IMCAS Asia 2025 As part of the congress, IBSA Derma will host a scientific symposium titled “The Future of Tissue Regeneration with NAHYCO® Technology. Feeling and Seeing the Results with Profhilo® Line” scheduled for Saturday, June 7, from 3:00 to 4:00 pm ICT in Room 1 - Level 2. Internationally renowned speakers – Dr. Lam Bee Lan and Prof. Ofir Artzi – will lead
HistoSonics Completes Enrollment in #HOPE4KIDNEY Trial Evaluating Non-Invasive Histotripsy to Treat Kidney Tumors6.6.2025 15:00:00 EEST | Press release
HistoSonics, Inc., the manufacturer of the Edison® Histotripsy System and novel histotripsy therapy platforms, today announced the completion of patient enrollment in its pivotal #HOPE4KIDNEY trial. This prospective, multi-center, single-arm trial is designed to evaluate the safety and effectiveness of the Edison System in destroying kidney tissue by treating primary solid kidney tumors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250606659747/en/ Edison Histotripsy System Procedure for Kidney Tumor Animation The trial enrolled patients with a single, non-metastatic solid kidney mass ≤3 cm, confirmed by imaging and biopsy. Subjects will be followed for five years post-procedure, with evaluations at multiple time points, including 14-day, 30-day, 90-day, 180-day, and annual assessments. The Edison System remains in investigational use for kidney applications and is not yet FDA-approved for this indication. Data from the #H
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