Miracor Medical Granted FDA Breakthrough Device Designation for the PiCSO Impulse System
22.8.2019 09:00:00 EEST | Business Wire | Press release
Miracor Medical SA (Miracor Medical) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its PiCSO® Impulse System for treatment of STEMI patients.
The FDA Breakthrough Device designation is intended to speed time to market for treatments of life-threatening or irreversibly debilitating diseases or conditions and recognizes the novelty of the PiCSO Impulse System and its potential to benefit patients with anterior STEMI heart attacks. The Centers for Medicare & Medicaid Services (CMS) also recently acknowledged the importance of this designation by establishing an alternative reimbursement pathway for products that receive FDA marketing authorization and held the Breakthrough Designation.
PiCSO therapy is provided by interventional cardiologists during PCI (Percutaneous Coronary Intervention) in patients experiencing ST-elevated myocardial infarction (STEMI). The PiCSO Impulse System clears the coronary microcirculation by intermittently occluding the coronary sinus outflow resulting in improved perfusion of the infarcted area of the heart. This mechanism of action is unique and very differentiated.
The PiCSO Impulse System is intended to reduce infarct size after STEMI, which is strongly associated with reductions in heart failure hospitalizations and reduced mortality1. Heart failure occurs in 18-28% of patients within the first 90 days after STEMI2 and the one-year mortality rate for STEMI is 14% despite all improvements and widespread use of reperfusion strategies and adjuvant pharmacological therapies3.
“The Breakthrough Designation demonstrates FDA’s continued commitment to encouraging medical device innovation to address clinical needs and improve patient care. This designation highlights the need for improving care of STEMI patients and will help Miracor accelerate the pathway in the USA.” said Olivier Delporte, CEO.
“Despite effective treatment, patients with STEMI often have large heart attacks, resulting in heart failure. Early studies have shown the potential for PiCSO to reduce infarct size in STEMI. The FDA Breakthrough designation acknowledges the need for therapies like PiCSO that may be able to reduce infarct size in patients with STEMI.” said Prof. Dr. Gregg Stone, NY, USA.
In July of this year, Miracor announced the start of its European randomized study, PiCSO-AMI-I, to further evaluate the benefits of PiCSO therapy as compared with conventional PCI for the treatment of anterior STEMI patients.
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 commercially available.
1 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.
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 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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190821005347/en/
Contact information
Olivier Delporte
CEO
Miracor Medical SA
odelporte@miracormedical.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
AI-driven Bot Attacks Surged 12.5x According to Thales Bad Bot Report29.4.2026 10:00:00 EEST | Press release
Thales today released the 2026 Bad Bot Report: Bad Bots in the Agentic Age, revealing a fundamental shift in how the internet operates, as AI-accelerated automation becomes a defining feature of modern digital infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428783532/en/ ©Thales The findings highlight three major structural changes: the emergence of AI agents as a new category of internet traffic, the dominance of automated activity over human interaction, and the rapid expansion of attacks targeting APIs and identity systems that serve as the backbone of digital business. AI Is Redefining Internet Traffic and Security The report shows that AI is not just increasing the volume of bot activity, but fundamentally changing its nature. In 2025, AI-driven bot attacks surged 12.5x compared to the previous year. More significantly, AI agents are now emerging as a third category of traffic, alongside traditional “g
OpenGate Capital Signs Definitive Agreement to Acquire Total Safety’s Europe and Middle East Division29.4.2026 10:00:00 EEST | Press release
OpenGate Capital (“OpenGate”), a global private equity firm, announced today that it has signed a definitive agreement to acquire the European and the Middle Eastern (“EMEA”) division of Total Safety, a Littlejohn & Co. portfolio company. Total Safety EMEA is a leading provider of mission-critical safety and compliance solutions serving petrochemical and oil & gas customers across EMEA. The company focuses on workforce protection and regulatory compliance in complex, safety critical environments. Terms of the acquisition were not disclosed. Headquartered in Diepenbeek, Belgium, Total Safety EMEA offers a fully integrated, one-stop platform spanning safety services, rental equipment and product sales. Services include the deployment of highly trained personnel for critical safety operations, short- and long-term rental of essential equipment and the supply of personal protective equipment. As a trusted partner embedded in highly regulated environments, Total Safety EMEA supports clients
Hytera to Host Global Partner Summit 2026 in Shanghai, Advancing AI-Powered Mission-Critical Communications29.4.2026 09:00:00 EEST | Press release
Hytera Communications, a leading global provider of critical communications technologies and solutions, today announced it will host its highly anticipated Hytera Global Partner Summit (HGPS) 2026 in Shanghai on May 8, 2026, bringing together partners from more than 60 countries worldwide. Held under the theme "Advancing Together", this year’s summit marks the return of HGPS to China after several years overseas. As Hytera’s flagship event, it serves as a key platform to deepen collaboration, align strategic priorities, and unlock new opportunities for shared growth in an increasingly dynamic global market. The agenda will feature executive keynotes, new product launches, technology workshops, and partner-focused discussions, offering participants valuable insights into market trends and future development directions. A major highlight of HGPS 2026 will be the immersive exhibition pavilion, showcasing Hytera’s end-to-end portfolio and next-generation AI-powered solutions. Spanning sect
Autonomous University of Sinaloa (UAS) Releases Study on the Positive Economic Impacts of Pacifico Mexinol Project in Northern Sinaloa29.4.2026 01:39:00 EEST | Press release
As part of an ongoing joint effort between the academic and commercial sectors, stemming from a Collaboration Agreement between the Autonomous University of Sinaloa (UAS) and Pacifico Mexinol (a subsidiary of Transition Industries) signed in 2024, UAS released the findings of the economic effects study of the world's largest ultra-low-carbon methanol plant, located near Topolobampo, Ahome, Sinaloa. The Pacifico Mexinol project is aligned with the UN Sustainable Development Goals by promoting the use of clean energy, the utilization of treated wastewater, and climate change mitigation. It protects local ecosystems and will generate thousands of local jobs. The project represents more than the construction of industrial infrastructure; it is a trigger for economic growth for northern Sinaloa and Mexico. The study estimated the direct and indirect economic effects of the project’s investment in terms of employment, income, value added, and social well-being; identified regional developmen
Suzano 2025 Annual Report on Form 20-F29.4.2026 00:32:00 EEST | Press release
Suzano S.A. (B3: SUZB3 | NYSE: SUZ) informs that its 2025 Annual Report on Form 20-F was filed on March 24, 2026 with the U.S. Securities and Exchange Commission. Holders of the Company’s equity securities can receive hard copies of the Annual Report, including its audited financial statements, without charge by request directed to: ri@suzano.com.br. This document is also available on Suzano’s website (http://ir.suzano.com.br/). For further information, please contact our Investor Relations Department: Phone: (+55 11) 3503-9330 E-mail: ri@suzano.com.br View source version on businesswire.com: https://www.businesswire.com/news/home/20260428152792/en/
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