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
Clene Nanomedicine Partners with Veristat to Reduce Biostatistical Output Time by 80% for ALS New Drug Application12.11.2026 19:09:00 EET | Press release
VeristatTM, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced that it has partnered with Clene Nanomedicine to cut the time to deliver biostatistical outputs for a pivotal ALS drug application submission by 80%. Veristat reduced the time from study data to validated tables, listings and figures (TLFs) from up to six weeks to just one week. Clene, a late-stage biotech company, leveraged Veristat’s recently launched InStat™ platform, the industry’s first zero-code, fully automated solution to accelerate clinical trial processes. Biostatistical TLFs sit on the critical path for submissions, yet most sponsors rely on antiquated processes that involve slow, manual workflows to produce them, making post-database lock one of the biggest bottlenecks to regulatory approval. To remove this barrier, Veristat uses its AI-enhanced platform to compress the timeline to submission-ready TLFs from weeks to days, with every output validated by stati
WHOOP Launches WHOOP Humans, the Most Verifiably Human Social Network12.11.2026 19:00:00 EET | Press release
WHOOP, the human performance brand, today launched WHOOP Humans, a new feature that lets members follow friends and family, share fitness, health, and performance data they choose, and support each other's progress. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112176779/en/ WHOOP Launches WHOOP Humans, the Most Verifiably Human Social Network For more than a decade, WHOOP has helped members better understand their own health and performance. Now, WHOOP Humans extends that experience beyond the individual, making it easier to celebrate achievements, encourage progress, and look out for the people who matter most. "In a world that's becoming increasingly artificial, we're building something deeply human,” said Will Ahmed, Founder and CEO of WHOOP. “This is the most verifiably human network ever launched. Every account represents a real person with a verified heartbeat. They have real goals, challenges, and achievements. T
Integrated Hubs for Green Chemistry Research Aim to Transform How Chemicals and Materials Are Designed12.11.2026 18:00:00 EET | Press release
The Gordon and Betty Moore Foundation today announced four Integrated Research Hubs to explore new frontiers in chemical design, from materials that respond to their surroundings to molecules designed for safety from the start. Bringing together global researchers across institutions and disciplines, the hubs will investigate fundamental principles that could enable new capabilities in chemicals and materials while improving performance and protecting human health and the environment. The research priorities emerged through extensive engagement with the scientific community to identify the questions that could transform what chemistry can achieve. Each hub will connect researchers across institutions around one of four green chemistry focus areas: Safer molecular design: Led by The George Washington University, this hub will combine artificial intelligence and quantum chemistry to embed safety into chemical design from the outset. Adaptive catalytic systems: Led by the Max Planck Insti
Roquette Highlights Scalable Excipient and Capsule Solutions for Regional and Global Pharmaceutical Markets at CPHI India 202612.11.2026 17:00:00 EET | Press release
Roquette, a global leader in plant-based ingredients and a leading provider of pharmaceutical excipients, will showcase its comprehensive portfolio of excipient and capsule solutions at CPHI India 2026, Hall 1, Booth 1I12 from November 23 to 25, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112803410/en/ Meet Roquette at CPHI India 2026, Hall 1, Booth 1I12 At the event, Roquette will demonstrate how it helps pharmaceutical manufacturers accelerate the journey from formulation to market with confidence. By combining technical expertise, trusted quality, meaningful innovation and close collaboration, Roquette helps customers address formulation, scale-up and manufacturing challenges across a broad range of pharmaceutical applications. As India continues to play a critical role in supplying medicines to patients around the world, pharmaceutical manufacturers face increasing demands for quality, regulatory compliance,
Tigo Energy and Google Cloud Pair AI-Powered Tools for Solar Installers and Utilities12.11.2026 16:00:00 EET | Press release
Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced a collaboration with Google Cloud to develop AI-enabled operational workflows for solar installers and distributed energy portfolios. By making core Tigo data and software products available through Google Cloud, Tigo aims to deliver faster deployment, simplified data integration, and additional insights with Gemini. The resulting workflows will help installers, asset managers, and energy operators more easily identify issues, prioritize actions, and automate routine operational tasks across growing fleets of distributed energy systems. As solar and storage portfolios expand, energy businesses are increasingly responsible for managing more sites, more system data, and more customer interactions without a proportional increase in operational resources. Through collaboration with Google Cloud, Tigo is developing AI-assisted workflows to help opera
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