This pivotal clinical trial, titled "EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study," conducted in Collaboration with the ACTION Learning Network (https://lnkd.in/eH3BTaTw) represents a significant milestone for Berlin Heart, the clinical community, and the patients that we serve.
With the completed enrollment, 40 patients have been treated with the EXCOR® Active in 15 Childrens Hospitals across the US. Our focus is to assess the performance, effectiveness, and safety of the innovative Berlin Heart EXCOR Active Driving System when used in conjunction with the approved EXCOR Pediatric Ventricular Assist Device. This established system has been crucial in bridging patients with end-stage heart failure towards heart transplantation, while being the only solution to treat infants and small children.
After a follow-up of a further three months the study data will be analyzed. The insights gained will play a pivotal role as Berlin Heart seeks market approval for the EXCOR Active driving unit in the United States. Developed with patient well-being in mind, the EXCOR Active system empowers increased patient mobility within various hospital settings.
Stay tuned for more updates as we continue our mission to enhance patient care and revolutionize the field of medical technology. Thank you for your ongoing support and commitment to our shared vision.
Find more about the IDE study: https://lnkd.in/ehx4jNPW
Bob Kroslowitz, ACTION (Advanced Cardiac Therapies Improving Outcomes Network)
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At Berlin Heart we do everything we can to provide people with heart failure with the best possible care. The aim of our work is to ensure that these patients live well despite their illness.
Berlin Heart develops, produces and markets innovative systems for mechanical circulatory support. With our products EXCOR® Adult and EXCOR® Pediatric, we cover the entire scope of medical indications. We are the only company in the world offering systems that can support patients of every age and size, from newborns all the way to adults.
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Find out more about Berlin Heart on www.berlinheart.de/en/
Learn more about the EXCOR® Active: https://lnkd.in/d-NKvTE
Berlin Heart on Youtube: https://lnkd.in/eggNbGyY
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The access to some or all shown products may be restricted due to country-specific regulatory approvals. IKUS and EXCOR Active are intended for professional healthcare facility environments only.
The use of EXCOR® VAD for adults, RVAD-support, EXCOR® Blood pumps with bileaflet valves, EXCOR® Venous Cannula, EXCOR® Arterial Cannula for Graft, Caddy quattro kit as well as Excor mobile is not FDA approved. EXCOR® Active is an investigational device approved for use in a clinical study under IDE# G200252 approved by the FDA.