Two Large Studies Demonstrate Complete Revascularization with Impella Heart Pumps Improves Ejection Fraction and Long-Term Patient Outcomes
The final results of the PROTECT III and Restore EF prospective studies demonstrate improved outcomes for high-risk PCI patients with the use of Impella heart pumps. The study results were reviewed this morning at Transcatheter Cardiovascular Therapeutics (TCT) 2021, the annual scientific symposium of the Cardiovascular Research Foundation, by Gregg Stone, MD, director of academic affairs for the Mount Sinai Health System in New York City. The presentation is available to watch on-demand at www.heartrecovery.com/tct-2021.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211104005652/en/
Gregg Stone, MD, reviews the final results of the PROTECT III study in the Clinical Science Theater at TCT 2021 (Photo: Business Wire)
“The contemporary data from these two prospective studies provide evidence that the adoption of Impella best practices is improving safety and reducing MACCE in the high-risk PCI patient population,” said Dr. Stone. “These best practices are being examined in a broader patient population as part of the ongoing PROTECT IV Randomized Controlled Trial of Impella in high-risk PCI, which hypothesizes that by providing hemodynamic stability during high-risk PCI, Impella will facilitate more optimal stent implantation and complete revascularization, and that will translate into improved early and late patient outcomes.”
PROTECT III Final Results
The PROTECT III prospective study demonstrates improvement in 90-day clinical outcomes, completeness of revascularization, and safety, when compared to the PROTECT II Randomized Controlled Trial (RCT). The PROTECT II RCT found, when compared to intra-aortic balloon pump (IABP), Impella use led to a 29% relative risk reduction in MACCE at 90 days.
Study authors analyzed patients in PROTECT III who would have qualified for PROTECT II, known as “PII-like” patients, and compared them to PROTECT II patients. PROTECT III patients had improved 90-day MACCE rates, compared to PROTECT II patients (15.1% vs. 21.9%, p=0.037). This is a relative risk reduction of 31%. (see figure 1)
The study authors also note that PROTECT III patients, when compared to patients in PROTECT II:
- Were more complex, with more severe calcification, more rotational atherectomy and more vessels treated.
- Had more complete revascularization, with 78% less hypotension during support (2.2% vs. 10.2%, p=0.0004).
- Had improved in-hospital safety, with significantly fewer bleeding complications requiring transfusion (1.2% vs. 9.4%, p<0.001).
Restore EF Final Results
The Restore EF prospective study demonstrates the use of contemporary best practices with Impella in high-risk PCI significantly improves left ventricular ejection fraction (LVEF), heart failure symptoms, and anginal symptoms at 90-day follow-up in a wide variety of hospital settings including rural, urban, community and academic centers.
The study of 251 patients at 26 hospitals showed:
- Significant improvement in LVEF from baseline to 90-day follow-up (35% to 45% p<0.0001). LVEF improvement at 90 days is the study’s primary endpoint. Restore EF is the latest study in a growing body of evidence demonstrating LVEF improvement with Impella-supported high-risk PCI. (see figure 2)
- Significant reduction of heart failure symptoms with 76% reduction in New York Heart Association (NYHA) classification III/IV at follow-up (62% to 15% p<0.001). (see figure 3)
- Significant reduction of anginal symptoms with 97% reduction in Canadian Cardiovascular Society (CCS) classification III/IV at follow-up (72% to 2% p<0.0001). (see figure 3)
Advancement in Technology and Best Practices
Since PROTECT II, Impella-supported high-risk PCI has evolved to include the more powerful Impella CP with SmartAssist heart pump, which was used in about two-thirds of the patients in the Restore EF and PROTECT III studies.
“Advancement in technology, along with best practice learnings and operator experience has led to improvements in patient outcomes in contemporary practice,” said Jeff Moses, MD, the lead investigator of the PROTECT III study, director of interventional cardiovascular therapeutics and professor of medicine at Columbia University Medical Center in New York City, and director of advanced cardiac interventions at St. Francis Hospital and Heart Center in Roslyn, NY. “These two studies expand upon prior research and demonstrate a clinical benefit in today’s broader patient population.”
The PROTECT series of studies and the Restore EF study are sponsored by Abiomed (NASDAQ: ABMD) as part of its commitment to improving clinical outcomes.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® devices are U.S. 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.
The Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are U.S. 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.
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.
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.
For further information:
Director of Communications
+1 (978) 882-8408
Vice President and Chief Financial Officer
+1 (978) 646-1680
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
NextSense Emerges to Unlock Brain Health with Key Partners UCB, Heraeus, UC San Diego, and Emory University3.12.2021 16:00:00 CET | Press release
NextSense, the foundation of brain health, came out of stealth with an announcement made from the AES (American Epilepsy Society) Annual Meeting in Chicago, where NextSense and its partners are presenting the results of their research on seizure detection to peers in academia and industry for the first time. NextSense unlocks brain health with real world data insights and practical, scientific wisdom for daily living. Traditional brain health monitoring technology like EEG machines and polysomnograms are too bulky for home use, requiring patients to stay overnight at hospitals or sleep study clinics for observation. The high cost of care and lack of comfort of these devices makes long-term and continuous monitoring nearly impossible. Not only are these data based on a single timeframe, they observe what is anything but an ordinary night’s sleep. And for anyone living with epilepsy, the unpredictability of seizures makes direct observation and high-quality data-gathering exceedingly rar
Healthcare + Expo Taiwan to Build an Ecosystem of Digital Transformation in Healthcare3.12.2021 15:15:00 CET | Press release
One of the largest trade fairs in the APAC region- the Healthcare+ Expo Taiwan- takes place on 2 to 5 December in Taipei. The Expo displays Taiwan’s strength in AI, Cloud-based Applications, Flat Panels, IoT and Technologies that make up Metaverse, reflecting the trend on digital transformation in healthcare driven by the global pandemic. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211203005002/en/ Expand Businesses into growing markets in the APAC region, with Healthcare+ B2B. Join medical institutes and companies in the fields of pharmaceuticals, biotechnology, health/ information technology, electronics and manufacturing to promote products, build partnerships and seize supply-demand opportunities. (Graphic: Business Wire) The Expo has an all-star lineup of corporates, including Acer, Asus, AUO, Delta Electronics, Innolux, Quanta and Wistron, demonstrate their technologies and solutions tailored to digital transformati
Eurofins Technologies Launches a New Multiplex RT-PCR Assay for Combined SARS-CoV-2 Screening and Rapid Detection of the Omicron (B.1.1.529) Variant of Concern3.12.2021 14:05:00 CET | Press release
Eurofins Technologies (Paris:ERF) announces the launch of the multiplex RT-PCR assay GSD NovaType Detect + Select K417N SARS-CoV-2. Within just one week since the first reports on the Omicron variant of concern, this kit has been developed as a quick response to identify its presence. The assay is designed for the simultaneous qualitative detection of SARS-CoV-2 genomic RNA and identification of the spike (S) mutation K417N in one reaction. The results of this RT-PCR assay can be obtained within 1 hour, which makes it a fast and cost-effective solution to identifying the presence of the Omicron variant before samples are confirmed by whole genome sequencing. Eurofins Technologies is constantly working to adapt its product offering to meet the challenges of the ongoing COVID-19 pandemic.. For more information, please visit Eurofins Technologies website. About Eurofins Technologies – a fast growing provider of diagnostic technologies in the field of immunoassays and molecular detection m
How Can Chinese Cities Increase Their Global Communications Impact? Joint Report and Index from CCG and Xinhuanet Sizes up Strategies and Offers Valuable Suggestions3.12.2021 13:53:00 CET | Press release
The Center for China and Globalization (CCG) and Xinhuanet, China’s leading online news portal, recently released a joint report evaluating the global communications impact of Chinese cities, analyzing the problems with their communication strategies, and offering suggestions on improving their ability to “go global”. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211203005279/en/ Report on the Chinese Cities Global Communications Impact Index (CCGCII) & Ranking of Chinese Cities by Global Communications Impact (Graphic: Business Wire) The study covered the top 100 cities in China as ranked by GDP in 2019, including Shanghai, Beijing, Shenzhen, Guangzhou, Chongqing, Chengdu, Wuhan, Tianjin, Dalian, and Xiamen . Based on big data from the Xinhua RIS data bank, which has collated over 10 million items of public information from overseas mainstream media and international social media platforms, the Chinese Cities Global Commun
Valuence Japan Nanboya, BRAND CONCIER Recognized as No.1 in Five Categories in Japan, Including for Overall Purchase Volume, for Luxury Brand Goods and Other Items!3.12.2021 10:55:00 CET | Press release
Valuence Japan Inc. (Tokyo; Susumu Muguruma, representative director), a member of the Valuence Group (TOKYO:9270), which operates 135 offices in Japan and 23 other countries(*1) specializing in the purchase of watches, bags, jewelry, precious metals, antiques, and art objects has announced the results of a survey on the purchase volume of brand goods conducted by ESP Research Institute, Inc. According to the survey, the company’s Nanboya and BRAND CONCIER brands placed in the top position in Japan in terms of overall annual purchase volume of luxury brand goods. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211203005167/en/ Valuence Japan Nanboya, BRAND CONCIER Recognized as No.1 in Five Categories in Japan, Including for Overall Purchase Volume, for Luxury Brand Goods and Other Items! Also Recognized as No.1 in Japan for Purchase Volume of Rolex and Other Watches, Jewelry, Apparel, and Accessories (Graphic: Business Wire)
Moody’s Acquires PassFort and Agrees to Acquire kompany, Expanding KYC and Compliance Capabilities3.12.2021 10:00:00 CET | Press release
Moody’s Corporation (NYSE:MCO) announced today that it has acquired PassFort Limited and entered into an agreement to acquire 360kompany AG (kompany), two European providers of onboarding and Know Your Customer (KYC) technology solutions. The acquisitions complement Moody’s technology, data, and analytical capabilities, and enhance its industry-leading customer solutions for KYC, anti-money laundering, compliance, and counterparty risk. “Our customers rely on our data and analytical tools to make decisions about who they do business with,” said Keith Berry, General Manager of Moody’s KYC business unit. “PassFort and kompany are innovators in the compliance and regulatory space, and their technologies will upgrade and accelerate our customers’ onboarding and monitoring processes.” PassFort is a U.K. SaaS-based workflow platform for identity verification, customer onboarding, and risk analysis. Its software delivers data from over 25 third-party providers and automates the collection, ve
DEXLEVO's Liquid Polymer Filler Raises KRW 26 Billion in Pre-IPO Funding3.12.2021 08:41:00 CET | Press release
DEXLEVO has completed its pre-IPO funding of KRW 26 billion. It thus increased its valuation by six times compared to the Series B funding in 2018 thanks to its commercialization performance such as obtaining the European Union’s CE certification on the liquid polymer filler (product name: GOURI) in May of this year. The company plans to build a new cGMP-grade (current Good Manufacturing Practice) production facility in Songdo with the proceeds raised this time and start marketing its flagship product. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211202006086/en/ DEXLEVO's GOURI, the world's 1st Fully Liquid type PCL Injectable. (Graphic: Business Wire) According to industry sources on November 25, DEXLEVO has completed a total of KRW 26 billion in pre-IPO funding from existing investors such as Magna Investment, Smilegate Investment, Hyundai Venture Investment Corp., and Shinhan Capital. Magna Investment and Smilegate Inv