Business Wire

Miracor Medical Announces FDA IDE Approval For PiCSO ® Pivotal Study

Share

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. The PiCSO-AMI-II multicenter, randomized trial will enroll 300 patients with anterior ST-segment Elevation Myocardial Infarction (STEMI) presenting with TIMI flow 0, 1, and 2 within 12 hours of symptom onset. The primary efficacy endpoint of the study will be infarct size measured by cardiac magnetic resonance imaging (CMR) at 5 days. The primary safety endpoint is a performance goal for device and procedure related adverse events at 30 days. Major adverse cardiac events and heart failure endpoints will be captured acutely and for up to 3 years.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220823005069/en/

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

PiCSO® Impulse Catheter (Photo: Business Wire)

PiCSO-AMI-II will be the second major randomized trial to evaluate the role of PiCSO in improving coronary microvascular function and reducing infarct size in patients presenting with anterior STEMI. Miracor is currently recruiting 144 patients in PiCSO-AMI-I, a landmark European randomized controlled trial, with comparable endpoints as the approved US trial. Recruitment in the European study is expected to end this summer. It is anticipated that a future patient-level pooled meta-analysis of the two studies will demonstrate a hard clinical endpoint improvement in heart failure hospitalization.

PiCSO is used as an adjunctive procedure after epicardial flow has been restored during the primary percutaneous coronary intervention (PCI) procedure. The unique mechanism of action, of intermittently occluding the coronary sinus outflow, redistributes venous blood-flow to the peri-infarct zone and enhances the coronary microcirculation viability by washing-out debris and other noxious agents of the infarct process. Early non-randomized European studies have suggested that this leads to reduced incidence of coronary microvascular obstruction (MVO) [3,4] and smaller infarct size, which are both strongly correlated to improvement in heart failure hospitalizations and reduced mortality following primary PCI [5]. Despite improvements in patient care pathways, widespread use of reperfusion strategies, and adjuvant pharmacological therapies, the one-year mortality rate after STEMI in high-risk patients has plateaued over the past decade at 14% [1]. Also, heart failure development after hospital discharge is very prevalent, being diagnosed in approximately 13% of patients at 30 days and 20–30% at 1 year after discharge [2].

“Reducing infarct size and MVO is a key factor in improving survival and reducing the risk of heart failure among patients with heart attack. PiCSO therapy is a promising new therapy to reduce infarct size and improve outcomes in anterior STEMI patients. The FDA-approved randomized IDE trial has been designed to validate the safety and effectiveness of PiCSO.” said Prof. Gregg W. Stone, (Director of Academic Affairs for the Mount Sinai Heart Health System, New York, NY, USA) who will be study principal investigator, with Prof. Marco Valgimigli of Istituto Cardiocentro Ticino in Lugano, Switzerland, as the study co-principal investigator.

“In addition to the ICD-10-PCS code that was granted by the Centers for Medicare and Medicaid Services (CMS) in April 2022, the Investigational Device Exemption marks a key milestone in the company’s lifecycle and speaks to the positive evolution of the company. We look forward to conducting a meticulous study with our clinical investigators to bring PiCSO to American patients.” said Olivier Delporte, CEO. The company plans to raise funds later this year to execute this important study, support company operations and assess potential partnerships for Asia.

The PiCSO Impulse System received ‘Breakthrough Designation’ from the FDA in 2019 and the CE-Mark in 2020. The development of Miracor’s PiCSO technology is supported by a reimbursable cash advance from the Walloon Region since August 2017.

About Miracor Medical

Miracor Medical (www.miracormedical.com), located in Awans, Belgium, provides innovative solutions for the treatment of severe cardiac diseases, aiming to improve short and long-term clinical outcomes and reduce associated cost.

Miracor Medical was originally founded by a cardiac surgeon at the Medical University of Vienna, Austria, Professor emeritus Werner Mohl. Prof. Mohl has worked and published about coronary sinus occlusion and interventions for decades, and invented the PiCSO therapy concept. Miracor Medical has developed the PiCSO Impulse System, the first and only coronary sinus intervention designed to reduce infarct size, improve cardiac function by clearing microcirculation and potentially reduce the onset of heart failure following acute myocardial infarction.

# # # # #

NOTE: The PiCSO® Impulse System is limited to investigational use in the United States.

  1. Szummer, K., et al., Improved outcomes in patients with ST-elevation myocardial infarction during the last 20 years are related to implementation of evidence-based treatments: experiences from the SWEDEHEART registry 1995–2014. European Heart Journal, 2017. 38(41): p. 3056-3065.
  2. Jenča, D., et al., Heart failure after myocardial infarction: incidence and predictors. ESC Heart Failure, 2021. 8(1): p. 222-237
  3. Egred, M., et al., Effect of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) on infarct size in anterior STEMI: PiCSO in ACS study. IJC Heart & Vasculature, 2020. 28: p. 100526.
  4. De Maria et al. Index of microcirculatory resistance-guided therapy with pressure-controlled intermittent coronary sinus occlusion improves coronary microvascular function and reduces infarct size in patients with ST-elevation myocardial infarction: the Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion study (OxAMI-PICSO study). EuroIntervention 2018;14(3):e352-e359.
  5. Stone et al. Relationship Between Infarct Size and Outcomes Following Primary PCI: Patient-Level Analysis From 10 Randomized Trials. J Am Coll Cardiol. 2016 Apr 12, 67(14), 1674-1683.

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

Contact information

Olivier Delporte
CEO
Miracor Medical SA
odelporte@miracormedical.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

Blue Yonder Announces Binding Agreement To Acquire One Network Enterprises for Approximately $839 Million To Create Multi-Enterprise Supply Chain Ecosystem29.3.2024 13:13:00 CET | Press release

Blue Yonder, a leader in digital supply chain transformations, continues its forward momentum to revolutionize the supply chain and has today announced the signing of an agreement to acquire One Network Enterprises (One Network) for approximately $839 million, subject to adjustments. One Network, provider of the Digital Supply Chain Network™, is known for its autonomous and resilience services and is a leading global provider of intelligent control towers. Upon completion, Blue Yonder will be well positioned to serve customers’ needs across planning, execution, commerce, and networks. “Supply chains have become more complex, and as more and more companies reduce risk by diversifying sourcing of products globally, there is an increased demand for the sharing of information and resources across the whole value chain. This, along with increased disruptions and geopolitical risks, have put the pressure on organizations to build more resilient and robust supply chains,” said Duncan Angove,

Dubai Electricity and Water Authority PJSC Shareholders Approve Payment of AED 3.1 Billion in Dividends29.3.2024 13:12:00 CET | Press release

Dubai Electricity and Water Authority PJSC (ISIN: AED001801011) (Symbol: DEWA), the Emirate of Dubai’s exclusive electricity and water services provider and majority owner of the largest cooling services provider, which is listed on the Dubai Financial Market (DFM), reported that its shareholders have, in the general assembly held on March 28th, 2024, approved the payment of total dividend of AED 3.1 billion with a record date of April 8th, 2024. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240329162756/en/ Dubai Electricity and Water Authority PJSC shareholders approve payment of AED 3.1 billion in dividends (Photo: AETOSWire) General Assembly Details The meeting, chaired by HE Matar Humaid Al Tayer, Chairman of the Board of Directors of DEWA, was attended by HE Saeed Mohammed Al Tayer, MD & CEO of DEWA and Members of the Board of Directors of DEWA as well as 85.9% of the shareholders. The assembly was held on Thursday (2

PAN Finance Names Libertex ‘Global CFD Broker of the Year’29.3.2024 06:25:00 CET | Press release

As the first quarter of 2024 draws to a close, Libertex is thrilled to announce its first accolade of the new year! The established global financial publication PAN Finance has determined Libertex to be the ‘CFD Broker of the Year – Global 2024’ following a rigorous evaluation process conducted by the publication's highly experienced editorial and research teams. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240328235325/en/ (Graphic: Libertex) PAN Finance is a trusted source of global financial intelligence with an impressively wide readership across 150 countries. Its ecosystem includes a quarterly magazine, special reports, a news website, and various social media channels. As an organisation, PAN Finance is committed to providing concise, intelligent, and up-to-date news for a worldwide readership of specialists spanning the entire finance industry. The company's awards programme aims to serve as a true indicator of exc

Midea Group releases its first-ever ESG brand story with an unexpected VIP visit highlighting its commitment to sustainability.29.3.2024 02:39:00 CET | Press release

Midea Group: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240328526418/en/ Background: Midea Group, a leading global technology group, recently released its 2023 Environmental, Social, and Governance (ESG) Report with ambitious sustainable development goals set for 2030. They include achieving over 500 megawatts of photovoltaic power generation, reducing greenhouse gas emission intensity (scopes 1 and 2) by 0.040, secure Energy Management System Certification for 50 factories, and achieve 100% carbon footprint accounting for major categories of smart home appliances. This is aligned with the Sustainable Development Report Standards of the Global Report Standards of the Global Reporting Initiative (GRI). The new report and campaign focuses on four dimensions: Protect the Blue Planet, Build a Harmonious Community, Practice 'Bring Great Innovations to Life', and Jointly Create the Prosperous Ecology. The campaign: Midea’s ESG

DC Secretary Announces Annual Determinations Committees Outcome28.3.2024 21:14:00 CET | Press release

DC Administration Services, Inc. has today announced the composition of five regional Determinations Committees (DCs), effective from April 27, 2024. Voting Dealers (for all regions): Voting Non-Dealers (for all regions): Bank of America N.A. Citadel LLC Barclays Bank plc Elliott Management Corporation BNP Paribas Pacific Investment Management Company LLC Citibank, N.A. Deutsche Bank AG Goldman Sachs International JPMorgan Chase Bank, N.A. Voting Dealer for the Americas, EMEA, AEJ, and Japan Determination Committees: Mizuho Securities Co., Ltd. The process for selecting DC members is specified in the DC rules. The DC rules, along with more information about the Determinations Committees and what they do can be found at the Determinations Committees website: https://www.cdsdeterminationscommittees.org/. View source version on businesswire.com: https://www.businesswire.com/news/home/20240328441002/en/Contact information Press Inquiries: Orlando Figueroa orlando.figueroa@citadelspv.com

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
HiddenA line styled icon from Orion Icon Library.Eye