Business Wire

Miracor Medical Starts PiCSO-AMI-I Randomized Study in EU

Share

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.

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

Schlumberger Announces Fourth-Quarter and Full-Year 2019 Results Conference Call6.12.2019 21:07:00 EETPress release

Schlumberger Limited (NYSE:SLB) will hold a conference call on January 17, 2020 to discuss the results for the fourth quarter and full year ending December 31, 2019. The conference call is scheduled to begin at 8:30 am US Eastern time and a press release regarding the results will be issued at 7:00 am US Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (844) 721-7241 within North America or +1 (409) 207-6955 outside of North America approximately 10 minutes prior to the start of the call and the access code is 4013483. A webcast of the conference call will be broadcast simultaneously at www.slb.com/irwebcast on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until February 17, 2020, and can be accessed by dialing +1 (866) 207-1041 within North Amer

BUFF STUDIO Globally Launches My Coloring, a Mobile 3D Pixel Art Coloring Book Game6.12.2019 16:00:00 EETPress release

BUFF STUDIO announced on December 5 that it launched My Coloring, a mobile 3D pixel art coloring book game, in 155 countries simultaneously. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191206005162/en/ BUFF STUDIO launched My Coloring, a mobile 3D pixel art coloring book game, in 155 countries simultaneously. My Coloring is a game that materializes a 3D pixel art coloring book on mobile devices. You can blow your stress away as you paint spaces in the order of numbers on the screen while reading calming messages. Relaxing background music you will listen during gameplay and its fairytale-like design will give you pleasure and happiness. You can download it for free on Google Play and the Apple App Store. (Graphic: Business Wire) Its Android and iOS versions were released at the same time so the users can download it for free on Google Play and the Apple App Store. My Coloring is a game that materializes a 3D pixel art col

Horizon8 Opens European Headquarters in Cork with Plans for up to 50 Jobs6.12.2019 15:00:00 EETPress release

Horizon8, an innovative, technology solutions company today opens its European headquarters in Cork, Ireland. Formerly called HengTian, the Company was created in 2004 as a strategic partnership between Boston based State Street, and Hangzhou based Insigma Technology and Zhejiang University. The new office in Cork will mark the first European office for Horizon8 adding to the company’s North American presence in Boston. An Tánaiste (Deputy Prime Minister), Simon Coveney, T.D. commenting on the opening said: “This announcement is great news for Cork and indeed Ireland. With up to 50 jobs planned, Horizon8 is placing a significant vote of confidence in the Irish Market and further demonstrates our competitive position in attracting Foreign Direct Investment. All of these roles will be for high-skilled workers, including engineers, developers and business consultants. As a Government, we have been committed to making sure that there is a strong pipeline of job opportunities outside of Dub

UAE Company Completes GBP 300 Million Investment in UK6.12.2019 12:58:00 EETPress release

Twenty14 Holdings, the hospitality investment arm of LuLu Group International, has completed investments of US$ 390 million in UK with the inauguration of the Great Scotland Yard in London today. The hotel will be open for business from December 9, 2019. The historic property was acquired in 2015 for GBP 110 million, and the makeover of the hotel involved a further GBP 50 million. In addition to the Great Scotland Yard, Twenty14 Holdings had acquired the celebrated Waldorf Astoria Edinburgh – The Caledonian in Scotland in 2018. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191206005122/en/ The Great Scotland Yard being formally inaugurated by Nicky Morgan, Secretary of State, Lord Jonathan Marland, Sir Edward Lister, UAE Ambassador HE Mansoor Abulhoul, Indian High Commissioner Ruchi Ghanshyam, Hyatt Hotels Global President & CEO Mark Hoplamazian in the presence of LuLu Group Chairman Yusuffali MA and Twenty14 Holdings MD Ad

Autodoc GmbH adapts its storage capacity to strong company growth6.12.2019 12:08:00 EETPress release

Autodoc, the benchmark in online retail for car spare parts in Europe, is expanding its logistics locations in Szczecin and Berlin. With above-average growth in recent years, the demands placed on logistics have become increasingly extensive. In 2018 as a whole, around five million orders were processed and delivered at the two Autodoc warehouses in Berlin and Szczecin. In the current year, the 6 million mark in orders was already exceeded by mid-November. In order to meet Europe-wide demand in the future as well, Autodoc has rented additional warehouse space in Szczecin and at its main location in Berlin. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191206005110/en/ The Autodoc warehouse in Szczecin, Poland, will provide around 27,000 m² of storage space from spring 2020. (Photo: Business Wire) Expansion of logistics capacities is a key growth factor Autodoc saw itself as a European company from the outset and identified

Play harnesses ADVA timing solution for 5G-ready mobile network6.12.2019 11:00:00 EETPress release

ADVA (FSE: ADV) today announced that Play has deployed its Oscilloquartz timing solution to provide LTE Advanced services throughout Poland and prepare its network for 5G. The PTP grandmaster with dual integrated GNSS antenna enables Play to deliver the resilient and accurate Precision Time Protocol (PTP) frequency and phase synchronization needed for next-generation connectivity. With its ultra-compact design, the OSA 5405 Series empowers Play to migrate its radio access network from costly GNSS RF antennas and coax cables to standard copper and fiber Ethernet cabling, dramatically reducing capital expenditure and operating expenses. ADVA’s long-term partner NAVI also played a key role in the project. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191206005008/en/ ADVA's OSA 5405 timing technology is helping Play prepare for 5G (Photo: Business Wire) “This deployment is about taking our RAN infrastructure to the next level.

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