SCAI 2022 Scientific Sessions Highlight Impella Research, Advancements to Improve Cardiogenic Shock Outcomes

Rhea-AI Summary

Abiomed (NASDAQ: ABMD) highlights significant advances in heart support technologies at the SCAI 2022 Scientific Sessions, held in Atlanta from May 19-22. A large meta-analysis involving 6,810 acute myocardial infarction cardiogenic shock (AMICS) patients indicates that pre-PCI Impella support correlates with improved short- and mid-term survival rates, reducing mortality from 53.6% to 37.2%. Additionally, the company announces the full market launch of Impella RP with SmartAssist, designed for circulatory support, and FDA approval for a heparin-free sodium bicarbonate purge solution, enhancing patient management.

Positive

• Meta-analysis shows pre-PCI Impella support significantly reduces short-term mortality from 53.6% to 37.2%.
• Mid-term mortality rates for patients receiving Impella support pre-PCI are lower at 47.9% compared to 73%.
• Full market launch of Impella RP with SmartAssist, FDA approved for circulatory support up to 14 days.

Negative

• None.

DANVERS, Mass.--(BUSINESS WIRE)-- Abiomed (NASDAQ: ABMD), a leader in breakthrough heart, lung and kidney support technologies, will feature the most recent Impella research and technological advances aimed at improving outcomes for acute myocardial infarction cardiogenic shock (AMICS) patients during the Society for Cardiovascular Angiography and Interventions (SCAI) 2022 Scientific Sessions, May 19 – 22, in Atlanta.

Impella RP with SmartAssist is the first single-access temporary percutaneous ventricular support device with dual-sensor technology. (Photo: Business Wire)

Below is a summary of Abiomed’s SCAI highlights:

Large Meta-Analysis Shows Association Between Pre-PCI Impella Support and Increased Survival

Researchers identified 13 studies in the PubMed and Cochrane databases, representing 6,810 AMICS patients. The patients were divided into two groups – those who received Impella support pre-PCI (n=2,970) and those who received Impella support during or post-PCI (n=3,840). The data showed significantly reduced short-term mortality rates in AMICS patients who received Impella support pre-PCI, compared to those who received Impella support during or post-PCI (37.2% vs 53.6%, p=0.002). Midterm mortality was also lower in AMICS patients who received Impella support pre-PCI compared to those who received it during or post-PCI (47.9% vs 73%, p=0.022).

This meta-analysis published online on May 6 in the International Journal of Cardiology. Lead author Mario Iannaccone, MD, an interventional cardiologist at San Giovanni Bosco Hospital, ASL Città di Torino, Turin, Italy, will present the study results at SCAI on Friday, May 20, starting at 12:00 pm EDT. Details of the presentation and the study abstract are available on the SCAI 2022 Scientific Sessions website.

“These results add to a plurality of evidence that the timing of Impella placement for AMICS may impact mortality rates, and that placing AMICS patients on Impella support prior to PCI can improve their survival in both the short and midterm,” said Dr. Iannaccone.

Impella RP with SmartAssist Full Market Launch

SCAI will mark the full market launch of Impella RP with SmartAssist, the only right heart pump equipped with dual-sensor technology to assist with pump management. Impella RP with SmartAssist pumps blood from the inferior vena cava to the pulmonary artery and enables biventricular support when the left side is supported with a left-side Impella. The FDA has granted its highest level of approval to Impella RP with SmartAssist to provide circulatory support for up to 14 days in certain patients.

Data from the SHOCK Trial and Registry has shown that 37% of AMICS patients exhibit right ventricular dysfunction, which leads to a three times increased risk of mortality. A FDA post-market approval study showed the use of Impella RP within 48 hours of cardiogenic shock onset leads to 73% survival, compared to 14% survival when implanted after 48 hours of cardiogenic shock when heart failure is present.

Heparin-free Impella Purge

SCAI also provides Abiomed an opportunity to highlight its latest FDA approval, which simplifies Impella management with the goal of improving patient outcomes. On April 19, the US Food and Drug Administration granted pre-market approval for the use of sodium bicarbonate purge solution as an alternative to heparin. This sodium bicarbonate option is for patients who are intolerant to heparin or for whom heparin is contraindicated due to heparin-induced thrombocytopenia or bleeding.

ABOUT ABIOMED

Based in Danvers, Massachusetts, USA, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support and oxygenation. Our products are designed to enable the heart to rest by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. For additional information, please visit: www.abiomed.com.

ABOUT IMPELLA HEART PUMPS

Impella 2.5® and Impella CP® are US FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI), such as stenting or balloon angioplasty, to reopen blocked coronary arteries.

Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are US FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.

Impella RP® and the Impella RP® with SmartAssist® System are 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.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220518005230/en/

Media:

Jenny Leary

Associate Director, U.S. Communications

+1 (978) 882-8491

jleary@abiomed.com

Investor:

Todd Trapp

Vice President and Chief Financial Officer

+1 (978) 646-1680

ttrapp@abiomed.com

Source: Abiomed

FAQ

What are the highlights of Abiomed's presentation at SCAI 2022?

Abiomed's presentation at SCAI 2022 includes a meta-analysis showing improved survival rates for AMICS patients receiving pre-PCI Impella support, and the launch of Impella RP with SmartAssist.

What did the meta-analysis reveal about Impella support?

The meta-analysis revealed that pre-PCI Impella support significantly reduces short-term mortality rates in AMICS patients from 53.6% to 37.2%.

What is the Impella RP with SmartAssist?

The Impella RP with SmartAssist is a right heart pump featuring dual-sensor technology, allowing for circulatory support for up to 14 days.

What FDA approvals were announced by Abiomed?

Abiomed announced FDA approval for a heparin-free sodium bicarbonate purge solution to simplify Impella management.

When will the study results from the meta-analysis be presented?

The study results from the meta-analysis will be presented on May 20 during the SCAI 2022 Scientific Sessions.