DUBLIN--(BUSINESS WIRE)--FIRE1 today announced that the first U.S. patients have been successfully implanted with its FIRE1™ System for remote heart failure monitoring in an Early Feasibility Study. The study will assess FIRE1’s novel solution to improve outcomes for heart failure patients. The first patient was implanted at Austin Heart, Texas, where Kunjan Bhatt, MD, leads the study as Principal Investigator and Thomas McMinn, MD, performed the implants.
“We are delighted to announce the first implants in the U.S. of this new, transformative technology for patients with chronic heart failure,” said Dr. Bhatt. “The procedures were very straightforward, and the patients tolerated the procedure well without any complications. We are excited to use the unique insights we will get from this device to improve patient care. On behalf of Austin Heart, the Heart Hospital of Austin, and St. David’s Healthcare, we are honored to launch research of this technology in the U.S.”
“This device may offer a completely new way of measuring chronic heart failure,” said Nir Uriel, MD, National Principal Investigator for the study and Director of Heart Failure, Heart Transplant and Mechanical Circulatory Support programs at New York-Presbyterian. “The data gathered outside of the U.S. has been promising, and we look forward to studying its use in the U.S.”
Dr. Uriel is also a Professor of Medicine in the Division of Cardiology at Columbia University Vagelos College of Physicians and Surgeons and an adjunct Professor of Medicine in the Greenburg Division of Cardiology at Weill Cornell Medicine.
FIRE1 CEO and President Conor Hanley said, “We have made great clinical progress in Europe and I am proud to announce the milestone of first cases in the U.S., the largest healthcare market in the world. I want to express my gratitude to all the patients who continue to put their faith in us and their care teams who are working tirelessly to bring this important technology to market. The FIRE1 team is committed to its mission of helping millions of patients living with heart failure to get their normal lives back, and today is an important step forward on this journey.”
About Austin Heart
Austin Heart is the largest provider of cardiac and vascular services in Central Texas, specializing in cardiology, congestive heart failure, invasive cardiology, cardiovascular disease, interventional cardiology, venous disorders, peripheral vascular interventions and valvular heart disease. Austin Heart is part of the HCA Healthcare family and is affiliated with St. David’s HealthCare. Further information: https://austinheart.com/services/, http://stdavids.com/
About FIRE1
Headquartered in Dublin, Ireland, FIRE1 is a connected medical device solutions company dedicated to improving outcomes for people suffering with chronic diseases. Its investors include Andera Partners, Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic, New Enterprise Associates, Novo Holdings and Seventure. Its mission is to empower millions of people suffering from heart failure to get their normal lives back. The FIRE1 team is led by an experienced medical devices team that is working closely with world-leading researchers, clinicians, patients and payors to help reduce the burden of heart failure. Further information: www.fire1foundry.com.
More information about the Early Feasibility Study may be found on clinicaltrials.gov.
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