Miracor Medical Announces FDA IDE Approval For PiCSO® Pivotal Study

AWANS, Belgium–(BUSINESS WIRE)–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.

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.

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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.