Miracor Medical Starts PiCSO-AMI-I Randomized Study in EU
Miracor Medical SA (Miracor Medical) today announced the initiation and first patient enrollment in the PICSO-AMI-I study to evaluate the benefits of PiCSO® therapy compared with conventional PCI for the treatment of anterior STEMI patients.
The first patient enrolled into this study was treated at Oxford Heart Center, Oxford, UK by Professor Adrian Banning, the principal investigator of the study. “We are delighted to be initiating the PiCSO-AMI-I study. This study will explore the potential for PiCSO therapy to significantly improve the care of patients with larger heart attacks. My group and I have treated over 30 patients with the PiCSO therapy and we are excited to start this important randomized study, which builds upon the existing registry data. Improving outcomes for patients with large heart attacks is an important challenge and is an important unmet need currently. With this trial we hope to help define the long-term impact and benefits of the PiCSO therapy,” says Prof. Banning.
PICSO-AMI-I is a prospective, randomized, double-arm, multicenter study and will enroll 144 patients presenting with anterior STEMI, TIMI 0 & 1 Flow, at up to 9 clinical sites in Western Europe. The study is designed to prove superiority of PiCSO used as an adjunct to PCI over a conventional strategy of PCI alone, in reducing infarct size measured by CMR at 5 days.
Secondary efficacy endpoints include MVO and cardiac function (EF, LVESV, LVEDV) at 5 days and 6 months. Secondary clinical endpoints include death, heart failure-related hospitalization, new onset or worsening of heart failure. The clinical endpoints will be followed up annually for 3 years.
The PiCSO therapy has shown in several clinical studies positive results. Data from two recent studies (“PiCSO in ACS” and “OxAMI-PICSO”) showed that the use of the PiCSO Impulse System is associated with a significant infarct size reduction 1,2. Furthermore, OxAMI-PICSO showed an early improvement of coronary microvascular function post PiCSO treatment. PiCSO therapy accelerates the microcirculatory recovery resulting in significantly lower IMR (Index of Microcirculatory Resistance) at 24-48 hours when compared to controls leading to overall infarct size reduction 1.
“We are thrilled to start this randomized clinical trial in Europe, and to include world-leading institutions in our clinical investigation. This study is designed to provide the definitive proof of the clinical benefit of PiCSO over conventional standard of care for STEMI patients, and has the potential to bring PiCSO to guidelines for the treatment of this STEMI patient population.”, says Olivier Delporte, CEO of Miracor Medical.
PiCSO therapy is provided during the PCI (Percutaneous Coronary Intervention) in patients enduring acute myocardial infarct (AMI). The PiCSO Impulse System clears the coronary microcirculation by intermittently occluding the coronary sinus outflow resulting in improved perfusion of the infarcted area. This mechanism of action is unique and very differentiated. The use of the PiCSO Impulse System offers advantages of reducing the infarct size after AMI, and infarct size reductions lead to reductions in heart failure hospitalizations and reduced mortality 3. Heart Failure develops in 18-28% of patients 90 days after their STEMI 4.
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 develops the PiCSO Impulse System, the first and only coronary sinus intervention designed to reduce infarct size, improve cardiac function and potentially reduce the onset of heart failure following acute myocardial infarction.
# # # # #
NOTE: The PiCSO® Impulse System is not commercially available.
1 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
2 Egred et al. Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) reduces Infarct Size after primary PCI: A propensity - controlled matched study (EuroPCR 2018 poster/abstract)
3 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.
4 Cahill et al. Heart failure after myocardial infarction in the era of primary percutaneous coronary intervention: Mechanisms, incidence and identification of patients at risk. World J Cardiol. 2017 May 26;9(5), 407-415.
Miracor Medical SA
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
Idriverplus Joins the “Automate with Velodyne” Ecosystem29.5.2020 20:31:00 CEST | Press release
Velodyne Lidar, Inc. and Idriverplus today announced an expanded partnership and Idriverplus inclusion into the Automated with Velodyne integrator ecosystem, which helps companies grow their businesses while using Velodyne lidar technology. Through the program, Velodyne will further collaborate with Idriverplus to support its continued innovation and promote Idriverplus autonomous vehicles, including street cleaners, passenger cars and logistics vehicles. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200529005589/en/ Velodyne Lidar, Inc. and Idriverplus announced an expanded partnership and Idriverplus inclusion into the Automated with Velodyne integrator ecosystem, which helps companies grow their businesses while using Velodyne lidar technology. (Photo: Velodyne Lidar) Recently, Velodyne signed a multi-year sales agreement with Idriverplus to provide Puck™ sensors for the mass production of autonomous vehicles. Idriverplu
Takeda Announces Compelling Data from the Phase 2 Trial of Pevonedistat Plus Azacitidine in Patients with Higher-Risk MDS29.5.2020 14:00:00 CEST | Press release
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced the results of the Phase 2 Pevonedistat-2001 trial will be presented during oral sessions at the virtual 56thAmerican Society of Clinical Oncology (ASCO) Annual Meeting and the virtual 25thEuropean Hematology Association (EHA) Annual Meeting. The study evaluated pevonedistat plus azacitidine versus azacitidine alone in patients with rare leukemias, including higher-risk myelodysplastic syndromes (HR-MDS). These results show that the combination of pevonedistat and azacitidine is a highly active, promising therapeutic approach and suggest benefit in the HR-MDS subgroup across multiple clinically meaningful endpoints, including overall survival (OS), event-free survival (EFS), complete remission (CR) and transfusion independence, with a safety profile similar to azacitidine alone. The Pevonedistat-2001 trial was designed as a proof-of-concept study in patients with HR-MDS, higher-risk chronic myelomonocytic leukemi
Takeda Receives Positive CHMP Opinion for Pre-Filled Syringe Presentation of TAKHZYRO ® (lanadelumab) for Use as a Preventive Treatment for Hereditary Angioedema Attacks29.5.2020 14:00:00 CEST | Press release
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on a Type II Variation regulatory application and recommended the approval of a pre-filled syringe presentation of TAKHZYRO® (lanadelumab). TAKHZYRO is a subcutaneous injectable prescription medication approved in Europe for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. HAE is a rare genetic disorder that results in recurrent attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat.1,2,3 “Our goal is to continuously innovate in all areas of HAE management,” said Isabel Kalofonos, Global Product Strategy Lead, HAE, Takeda. “This positive opinion marks another important step forward as we aim to enhance the experience of treatment administration for peo
Interim Data from the Open Label Phase 2 OPTIC Study of Iclusig ® (ponatinib) for Chronic Phase-CML Presented at the ASCO and EHA Virtual Meetings29.5.2020 14:00:00 CEST | Press release
Incyte (Nasdaq:INCY) today announced that data from the interim analysis of the Phase 2 OPTIC (Optimizing Ponatinib Treatment In CML) trial, which was sponsored by Takeda and co-funded by Incyte, will be presented during an oral session at the upcoming 2020 American Society of Clinical Oncology Virtual Meeting (ASCO20; May 29 – May 31) (Abstract #7502)1; and at the virtual 25th Congress of the European Hematology Association (EHA25; June 11 – 14) (Abstract #S172)2. The OPTIC trial is an ongoing randomized, open-label study prospectively evaluating response-based dosing regimens of Iclusig® (ponatinib) over a range of three starting doses (45 mg, 30 mg, 15 mg) with the aim of optimizing its efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML), who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. With a median follow up of approximately 21 months, data from the interim analysis of the OPTIC trial show that the optimal benefit-r
Takeda to Present Data from the ICLUSIG ® (ponatinib) Clinical Trial Program that Could Prove Practice-Changing for the Treatment of Chronic-Phase CML29.5.2020 14:00:00 CEST | Press release
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that interim analysis data from the Phase 2 OPTIC (Optimizing Ponatinib Treatment In CML) trial will be presented during an oral session at the virtual 56thAmerican Society of Clinical Oncology (ASCO) Annual Meeting and the 25thEuropean Hematology Association (EHA) Annual Meeting. The OPTIC trial is an ongoing, randomized, open-label study prospectively evaluating response-based dosing regimens of ICLUSIG® (ponatinib) over a range of three starting doses (45-, 30-, or 15-mg) with the aim of optimizing its efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML) who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. With a median follow-up of approximately 21 months, data from the interim analysis of OPTIC show that the optimal benefit-risk profile for ICLUSIG in patients with CP-CML is achieved with a daily starting dose of 45-mg and, upon achieving ≤1% BCR-A
LetsGetChecked Debuts FDA EUA-Authorized At-Home Coronavirus (COVID-19) Sure-track Test29.5.2020 13:57:00 CEST | Press release
LetsGetChecked, the leading direct-to-consumer at-home health testing and insights company, announces today the authorization of the new Coronavirus (COVID-19) Sure-track Test for at-home consumer use by the U.S. Food and Drug Administration under an EUA. The new test is authorized to serve at-risk individuals with a proprietary at-home PCR nasal swab test that delivers accurate and definitive results within 24 hours. Offering an end-to-end model, LetsGetChecked’s new Sure-track Test introduces the most complete FDA EUA-authorized Coronavirus at-home testing solution. The at-home Coronavirus (COVID-19) test incorporates a nasal swab and PCR lab analysis, offering convenient and secure results in 24 hours. Unlike serology tests that detect the presence of antibodies, the at-home COVID-19 test determines the presence or absence of SARS-CoV-2 viral RNA. LetsGetChecked’s Sure-track Test is the only FDA EUA-authorized at-home Coronavirus (COVID-19) test that owns all aspects of the testing