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
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
Jefferies Clients, Shareholders and Employees Contribute $10 Million to Charities Supporting Los Angeles Wildfire Relief17.1.2025 14:00:00 CET | Press Release
Jefferies announced today that it will donate $10 million to charities providing aid for first responders and the people and communities impacted by the wildfires across Los Angeles. The donation includes funds from Jefferies, voluntary contributions from its nearly 6,000 worldwide employees, and proceeds from the firm’s January 16 Doing Good Global Trading Day, which set aside 100% of net global trading commissions for charities. Rich Handler, CEO, and Brian Friedman, President of Jefferies, said: “We are so grateful for how the Jefferies network stepped up to support those in need in Los Angeles. These wildfires have inflicted heartbreaking devastation on communities and so many families, and we hope this donation will help deserving charities provide urgently needed relief.” Organization Charity Description Allocation Los Angeles Fire Department Foundation The LAFD is actively seeking funds to equip LAFD members battling wildfires with tools and supplies. $2,000,000 All Hands and He
SLB Announces Fourth-Quarter and Full-Year 2024 Results, Increases Dividend and Initiates $2.3 billion in Accelerated Share Repurchases17.1.2025 12:50:00 CET | Press Release
SLB (NYSE: SLB) today announced results for the fourth-quarter and full-year 2024. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250115789214/en/ The exterior of the SLB headquarters in Houston, Texas. (Photo: Business Wire) Fourth-Quarter Results (Stated in millions, except per share amounts)Three Months EndedChangeDec. 31, 2024Sept. 30, 2024Dec. 31, 2023SequentialYear-on-yearRevenue $9,284 $9,158 $8,990 1% 3% Income before taxes - GAAP basis $1,387 $1,507 $1,433 -8% -3% Income before taxes margin - GAAP basis 14.9% 16.5% 15.9% -151 bps -100 bps Net income attributable to SLB - GAAP basis $1,095 $1,186 $1,113 -8% -2% $0.77 $0.83 $0.77 -7% - Adjusted EBITDA* $2,382 $2,343 $2,277 2% 5% Adjusted EBITDA margin* 25.7% 25.6% 25.3% 8 bps 33 bps Pretax segment operating income* $1,918 $1,902 $1,868 1% 3% Pretax segment operating margin* 20.7% 20.8% 20.8% -11 bps -12 bps Net income attributable to SLB, excluding charges & credits*
Perpetual Atomics and QSA Global Sign Collaboration Agreement17.1.2025 11:03:00 CET | Press Release
Perpetual Atomics is excited to announce this collaboration, which will enable the processing of americium into sealed sources for use in radioisotope power systems, including radioisotope heater units (RHUs) and radioisotope thermoelectric generators (RTGs). This partnership is another step toward supporting sustainable and reliable power solutions for some of the most challenging environments in space. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250107229344/en/ Perpetual Atomics Team gathered at the University of Leicester (Photo: Business Wire) A University of Leicester spinout, Perpetual Atomics brings over 20 years of expertise in space nuclear power systems and exploration, delivering innovative, reliable solutions for powering space missions in extreme environments, including "surviving the night." QSA Global, with its extensive expertise in designing and producing commercial radioisotope sealed sources for indust
KKR and Gulf Data Hub Form Strategic Partnership to Scale One of the Middle East’s Largest Independent Data Center Platforms17.1.2025 09:40:00 CET | Press Release
Gulf Data Hub (“GDH” or the “Company”), one of the largest independent data center platforms in the Middle East focused on serving hyperscale demand across the Gulf countries, and KKR, a leading global investment firm, today announced that funds affiliated with KKR will acquire a stake in GDH. The investment, which is subject to customary regulatory approvals, is being made through KKR’s Global Infrastructure strategy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250117834785/en/ H.E. Dr Thani Bin Ahmed Al Zeyoudi and H.E. Omar Sultan Al Olama, presiding over the official signing of the strategic partnership between KKR and Gulf Data Hub by Tara Davies Co-Head of KKR EMEA and Co-Head of European Infrastructure and Tarek Al Ashram, CEO of Gulf Data Hub (GDH) (Photo: Business Wire) Established in 2012 and headquartered in Dubai, GDH, is one of the largest independent carrier and vendor neutral data center platforms in the Mi
Access Advance Announces Video Distribution Patent Pool in Response to Market Demand17.1.2025 00:00:00 CET | Press Release
Responding to growing market demand for an industry solution for codec licensing in the video distribution market, Access Advance LLC (“Advance”) is pleased to announce the launch of its Video Distribution Patent (“VDP”) Pool. The VDP Pool will build upon the success of Advance’s existing HEVC and VVC Advance Patent Pools, which are supported by a substantial majority of video codec implementers and patent owners. It will provide a single one-stop-shop license, covering internet streaming with all four of the most recently developed video codecs (i.e., HEVC, VVC, AV1, and VP9) available today, with fixed tiered pricing scaled to the size of the video distributor’s business. This structure provides simplicity and predictability to internet video distributors, allowing them to choose which codec(s) to use based on technical and business merits rather than royalty costs or the need to negotiate multiple licenses. According to Peter Moller, CEO of Advance, “In recent years, the industry ha
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