Business Wire

Restore EF Study Shows Heart Function, Symptom Improvements for High-Risk PCI Patients Supported by Impella

Share

Abiomed (Nasdaq: ABMD) announces the results of the Restore EF study demonstrate Impella-supported high-risk percutaneous coronary intervention (PCI) leads to significant improvements in left ventricular ejection fraction (LVEF), angina symptoms and heart failure symptoms at follow-up. The study, which published online August 12 in JSCAI, builds on the largest clinical data set ever collected for high-risk PCI and further validates the LVEF and quality of life benefits associated with Impella-supported procedures.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220816005340/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

Figure 1: 90-Day LVEF Improvement Following Impella-Supported High-Risk PCI

Restore EF is a prospective, multi-center study evaluating the best practices in contemporary PCI practice, including more complete revascularization. Participants received an Impella-supported high-risk PCI, also called an “on-pump PCI,” at one of 22 sites across the United States between August 2019 and May 2021. At 90-day follow up, study participants had:

  • A 29% relative improvement from baseline LVEF (n=251, p<0.0001), with a significantly greater improvement in LVEF for those who had a complete revascularization (characterized by a residual SYNTAX score of 0). (See figures 1 and 2)
  • Significant improvement in heart failure symptoms, with an overall 76% reduction in New York Heart Association Class III or IV heart failure symptoms (n=274, p<0.001). (See figure 3)
  • Significant improvement in angina symptoms, with an overall 97% reduction in Canadian Cardiovascular Society Class III or IV angina symptoms (n=260, p<0.0001). (See figure 4)

Participants with higher baseline LVEF (greater than 45%) also experienced significant symptomatic improvement, similar to patients with lower LVEF.

“The Restore EF study results add to the growing body of evidence demonstrating that Impella-supported high-risk PCI can lead to a more complete revascularization and considerable LVEF improvement,” said Jason Wollmuth, MD, Restore EF study principal investigator and an interventional cardiologist at Providence Heart Institute. “The improvement in angina and heart failure symptoms in those with near normal LVEF provides a clear benefit to this patient population that is aligned with the FDA’s 2018 decision to expand Impella’s indication to patients undergoing high-risk PCI with or without depressed ejection fractions.”

An accompanying editorial published in JSCAI, written by physicians from Massachusetts General Hospital and Harvard Medical School, concludes, "based on the encouraging report from Wollmuth et al, a heart team–based recommendation for PCI in CABG-ineligible patients appears reasonable for patients with ICM (ischemic cardiomyopathy)."

Results from Restore EF and the PROTECT III study, which published in the June 2022 edition of the American Heart Journal, further demonstrate the safety and benefits of Impella-supported high-risk PCI, including low bleeding and MACCE rates (composite of death, stroke, myocardial infarction and repeat procedures). Data from PROTECT III shows reduced MACCE rates compared to PROTECT II (15.1% vs. 21.9%, p=0.037) when Impella is used to achieve a more complete revascularization in a single setting for high-risk PCI patients. Operators from community and academic centers demonstrated low major bleeding rates of 2.5% in the Restore EF study and 1.8% in the PROTECT III study when contemporary best practices were followed.

“These results further demonstrate that high-risk PCI procedures supported by Impella employing contemporary best practices are safe and effective, providing a treatment option for patients who have historically had limited options to improve their quality of life,” said Mitul Patel, MD, the study’s first author and an interventional cardiologist at UC San Diego Health.

Restore EF and PROTECT III are the latest in a growing list of studies that demonstrate Impella-supported high-risk PCI leads to improvement in LVEF:

  • Journal of the American College of Cardiology, 2009 – The PROTECT I trial found patients who had a Protected PCI with Impella had a 31% improvement in LVEF at 30-day follow up. (From 26 ± 6% to 34 ± 11%, p=0.003).
  • Catheterization and Cardiovascular Interventions, 2011 – This study, led by Maini, et al., found a 17% improvement in LVEF at follow up, after a Protected PCI with Impella (p<0.0001).
  • Circulation, 2012 –The PROTECT II randomized controlled trial found Protected PCI with Impella led to a 58% improvement in NYHA Class III and IV heart failure symptoms at 90 days (p<0.001). The trial also found, during follow up after Protected PCI with Impella, patients had a 22% improvement in LVEF (p<0.001).
  • Journal of Interventional Cardiology, 2013 – This study, led by O’Neill, et al., suggests that early initiation of hemodynamic support prior to PCI with Impella 2.5 is associated with more complete revascularization and improved survival to discharge compared to post-PCI support (65.1% vs. 40.7%, p<0.003).
  • American Journal of Cardiology, 2013 – An analysis of the PROTECT II randomized controlled trial by Dangas, et al., found Impella use led to a 29% reduction in major adverse cardiac and cerebrovascular events (MACCE) at 90 days, compared to the use of the intra-aortic balloon pump (IABP) (p=0.042).
  • Journal of Interventional Cardiology, 2019 – This study, led by Burzotta, et al., found six months after a Protected PCI, the percentage of patients with LVEF greater than or equal to 35% increased by 205%, from 22% to 67% (n=79, p≤0.001). The study also found more complete revascularization was associated with significant LVEF improvement and survival.

These studies have led to the PROTECT IV randomized controlled trial, which began enrolling patients in April 2021. PROTECT IV compares on-pump PCI to off-pump PCI and is the final step on the clinical evidence pathway to a Class I recommendation for Impella use in high-risk PCI. PROTECT IV leverages the best practices that physicians have learned during the past 10 years of clinical studies that led to the exclusive FDA PMA approval of Impella for high-risk PCI.

Additional information about the Restore EF study, including case studies and interviews with the study’s authors, is available on HeartRecovery.com.

ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® with SmartAssist® 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.

ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed, Inc., is a leading provider of medical technology that provides 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: http://www.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.

Contact information

Media Contact:
Jenny Leary
Associate Director, U.S. Communications
+1 (978) 882-8491
jleary@abiomed.com

Investor Contact:
Todd Trapp
Vice President and Chief Financial Officer
+1 (978) 646-1680
ttrapp@abiomed.com

About Business Wire

Business Wire
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

New Study From Egon Zehnder and Kearney Debunks the Myth of a Workplace Generational Divide28.9.2022 16:00:00 CEST | Press release

Egon Zehnder, the world’s preeminent leadership advisory firm, in partnership with Kearney, a leading global management consulting firm, today released findings from a new survey with over 8,000 respondents from eight different countries dismissing the myth of a generation divide in the workplace and showing that despite what is often believed, Gen Z, Millennials, Gen X and Boomers are more alike than different when it comes to workplace matters. The survey, titled “Different Generations, Same Ideals: What Workers of All Ages Value in their Jobs,” analyzed the similarities and differences among generations and found that they share more commonalities, especially when it comes to personal well-being, work-life balance, and desired traits from leadership. The most notable difference between the generations is how each group defines and plans to achieve their career desires. Key Findings from the survey include: Personal well-being, stability, and work-life balance matter more than money

BYD Announces Pre-sale Prices of European Passenger Car Range28.9.2022 15:35:00 CEST | Press release

BYD announces the pre-sale prices of its new European passenger car range. The world’s leading manufacturer of new energy vehicles and power batteries immediately introduces three full-electric passenger vehicles which will be delivered to Norway, Sweden, Denmark, the Netherlands, Belgium, Luxembourg and Germany. Before the end of the year customers in France and the United Kingdom will also have access to BYD’s zero-emission vehicles. After that, more dealers will be appointed supporting BYD’s plans to cover all major markets in Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220928005587/en/ BYD Europe Product Premiere 2022 The pre-sale price for the BYD ATTO 3 is € 38,000. The BYD HAN and TANG pre-sale prices are € 72,000. These pre-sale prices apply to Germany as a reference for Europe and may differ from country to country. The three full-electric BYD vehicles are technologically advanced and well-suited to the e

Monrol Will Establish a Legal Entity and Manufacturing Facility in Germany28.9.2022 15:27:00 CEST | Press release

Following an ongoing assessment of its entire operation, Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) has decided to establish a legal entity and manufacturing facility in Germany. The new facility will focus on the manufacture of SPECT products and radiopharmaceutical products for radioligand therapy(*) such as Gallium-68 generator and n.c.a Lutetium-177. Developed by Monrol R&D teams, these products are widely used in the production of radiopharmaceuticals for cancer patients. The facility will also have a dedicated division for state-of-the art cGMP Contract Development and Manufacturing Organization (CDMO) services. Monrol plans to make the site a center of excellence for both radiopharmaceutical production and scientific and industry collaborative efforts to create innovations. The facility is expected to be up and running by 2026 at an estimated cost of around 30 million euros. (*) Targeted radioligand therapy is an innovative approach to cancer treatment that is considered to

Fore Biotherapeutics Announces Fast Track Designation Granted by FDA to FORE8394 for the Treatment of Cancers Harboring BRAF Class 1 and Class 2 Alterations28.9.2022 15:00:00 CEST | Press release

Fore Biotherapeutics (Fore Bio), a precision oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to FORE8934, its investigational, novel, small-molecule, orally available inhibitor for the treatment of patients with cancers harboring BRAF Class 1 (V600) and Class 2 (including fusions) alterations who have exhausted prior therapies. The FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track designation may become eligible for Accelerated Approval, Priority Review, or Rolling Review if relevant criteria are met. “The FDA's Fast Track Designation for FORE8394 underscores the urgent need faced by patients with advanced BRAF-muted cancers who have no other options,” said Stacie

Quectel Announces New SC680A LTE Smart Module to Drive Digital Transformation and Machine Vision AI Applications28.9.2022 15:00:00 CEST | Press release

Quectel Wireless Solutions, a global IoT solutions provider, today announces that it has released its new SC680A smart module which features broad connectivity options including LTE Cat 6, Wi-Fi 802.11ac and Bluetooth 5.0 with powerful system performance and rich multimedia functions. The SC680A smart module is targeted towards mid-tier IoT devices including POS and payment terminals, industrial handhelds for logistics and warehousing, in-vehicle infotainment and dashcam solutions as well as micro-mobility applications and small electric cars. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220928005031/en/ Quectel's new SC680A LTE smart module (Photo: Business Wire) “We are excited to introduce another highly integrated smart module which gives global customers more flexibility in their IoT device designs,” said Norbert Muhrer, President and CSO of Quectel. “It enables a variety of industrial and consumer IoT verticals with

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