MIRACOR-MEDICAL-SA
Miracor Medical SA (Miracor Medical) has announced the award of the CE Mark for its latest generation of PiCSO Impulse Catheter and PiCSO Impulse Console, which is indicated for the treatment of anterior STEMI patients. The new system features improvements in ease of use.
PiCSO therapy is delivered by interventional cardiologists during the primary PCI (Percutaneous Coronary Intervention) procedure in patients experiencing anterior ST-elevated myocardial infarction (STEMI). Despite all improvements and widespread use of reperfusion strategies and adjuvant pharmacological therapies1 the one-year mortality rate for STEMI has plateaued at 14% and heart failure occurs in up to 28% of patients within the first 90 days2 . However, via its unique mechanism of action, the PiCSO Impulse System reduces the infarct size by intermittently occluding the coronary sinus outflow leading to improved microcirculatory function. Infarct size is strongly associated with reductions in heart failure hospitalizations and reduced mortality3 .
The CE Mark file was supported by clinical data from both the PiCSO in ACS4 study, which was recently published, and the OxAMI-PiCSO5 study, confirming that the use of the PiCSO Impulse System is associated with statistically significant infarct size reduction. Furthermore, OxAMI PICSO showed improvement of coronary microvascular function post PiCSO treatment by accelerating the coronary microcirculation recovery resulting in significantly lower IMR (Index of Microcirculatory Resistance) at 24 to 48 hours when compared to controls, also leading to overall infarct size reduction.
“We are very excited to have CE Mark for the next-generation PiCSO Impulse System. This was an intense effort by everyone at Miracor and I wish to congratulate the Miracor team, our physician partners and clinical steering committee members for this achievement! The CE Mark is a great milestone and our market access strategies over the next 12-18 months will generate new clinical data and facilitate the commercial roll-out in the second half of 2021.” said Olivier Delporte, CEO.
Miracor is currently recruiting patients in a landmark European randomized controlled trial, PiCSO-AMI-I, to further demonstrate the benefits of PiCSO therapy as compared with conventional PCI for the treatment of anterior STEMI patients.
The development of Miracor’s PiCSO technology is supported by a reimbursable cash advance from the Walloon Region since August 2017. This financial grant covers 55% of the technical and clinical research for the product.
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 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 not approved for 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
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.
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
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.
5
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200622005335/en/
About 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
MarkLines Gen-AI Beta Version Released for Automotive Industry13.1.2026 01:00:00 CET | Press release
MarkLines Co., Ltd. (Headquarters: Minato-ku, Tokyo; President & CEO: Makoto Sakai; TYO:3901) announced its launch of the "MarkLines Gen-AI Beta Version," the new feature for B2B users in the automotive industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112383839/en/ "MarkLines Gen-AI Beta Version" can take questions in natural language and instantly give highly reliable, relevant data drawn from MarkLines’ extensive automotive database (Image: MarkLines Co., Ltd.) This AI-powered feature enables users to ask questions in natural language and instantly receive highly reliable, relevant data drawn from MarkLines’ extensive automotive database. Moreover, the system analyzes this information by leveraging the rich content across its platform and delivers clear, concise, text-based insights. By combining trusted data with advanced analytical capabilities through generative AI, this service represents a first-of-its-kind
Australian Defence Force Secures Satellite Communications on SES IS-2212.1.2026 22:30:00 CET | Press release
New agreement for uninterrupted UHF connectivity for Australian Defence Force through 2033, With Options Extending to 2041 Satellite communications solutions provider SES will provide secure uninterrupted satellite communications to the Australian Defence Force (ADF) for a minimum of 16 years thanks to a new extended agreement. The service will be provided via the SES Intelsat 22 satellite and an ultra-high frequency (UHF) military communications payload. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112137182/en/ Assistant Secretary Space Systems Branch, Michael Hunt, formalizes contract negotiations for the through-life support of the IS-22 satellite with Rory Welch, senior vice-president of service delivery at SES Space and Defense. Photos: Corporal Annika Smit Under the renewed arrangement, SES will reposition the IS-22 satellite to a new orbital slot specified by the ADF, continuing a mission that has been the corne
NetApp Appoints Paul Fipps to the Board of Directors12.1.2026 22:05:00 CET | Press release
NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced that Paul Fipps, President of Global Customer Operations at ServiceNow, has joined its Board of Directors. The board now has ten directors, nine of whom are independent, and 50% of whom have been appointed within the last five years. Fipps brings more than 20 years of experience driving technology-enabled growth and customer transformation. At ServiceNow, he currently leads global sales, customer success, partner ecosystems, and field operations. He previously served as EVP of Worldwide Sales at ServiceNow and as President of Under Armour Connected Fitness and Chief Experience Officer at Under Armour, overseeing global direct-to-consumer, connected fitness, and digital experiences. He also previously served on the advisory board of Quantum Metric. Fipps holds a B.S. in Information Systems, an MBA from the University of Baltimore, and is a graduate of The Wharton School’s Advanced Management Program. “P
FDA Accepts New Drug Application for Pimicotinib for the Treatment of Tenosynovial Giant Cell Tumor12.1.2026 20:00:00 CET | Press release
Not intended for Canada-, UK- or US-based media Merck, a leading science and technology company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) for pimicotinib as a systemic treatment for patients with tenosynovial giant cell tumor (TGCT). The application is based on the primary results and longer-term follow-up of the global Phase 3 MANEUVER study, which demonstrated deep and durable tumor responses and meaningful improvements in clinical outcomes with pimicotinib. “With pimicotinib, we have an opportunity to significantly advance care for people living with TGCT, a painful and debilitating disease that has few effective and well-tolerated treatment options beyond surgery,” said David Weinreich, Global Head of R&D and Chief Medical Officer for the Healthcare business of Merck. “Based on clinical trial results showing not only a reduction in tumor burden, but also the ability to help alleviate symptoms like pain an
Fabentech receives Marketing Authorization for Ricimed®, an antidote against ricin poisoning12.1.2026 19:32:00 CET | Press release
First Marketing Authorization granted in France for the treatment of ricin poisoning, one of the most toxic natural substances in the world and a recognized priority biological threat. Ricimed® addresses a previously unmet medical need in the management of severe and potentially fatal ricin intoxications.Supported by the French Ministry of the Armed Forces and Veterans Affairs (the Directorate General of Armaments and the French Military Health Service), the development of Ricimed® illustrates Fabentech’s transition to a new scale and, with recent support from the European HERA Invest program, reinforces its positioning as a reference player in medical countermeasures against biological threats, serving both civilian and military markets. Fabentech, a French biopharmaceutical company specializing in medical countermeasures against biological threats, today announces that it has been granted Marketing Authorization for Ricimed®, a treatment for ricin poisoning. This press release featur
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