Symphony Medical has begun enrolling patients in its phase II multi-center human clinical trial of a novel, non-destructive therapy designed to prevent sustained post-operative atrial fibrillation.
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Post-operative atrial fibrillation (AF) is the most common complication associated with the approximately 500,000 coronary artery bypass grafting and cardiac valve replacement surgeries performed each year.
The company’s novel post-operative AF procedure, developed in collaboration with clinicians at The Cleveland Clinic Foundation and St Mary’s Hospital and Imperial College School of Medicine in London, employs a non-ablative, non-surgical approach whereby a biopolymer that prevents the development of persistent atrial fibrillation is prophylactically injected into a specific location of a patient’s heart prior to the conclusion of an open chest cardiothoracic procedure.
According to numerous published studies cited by the company, the incidence of post-operative AF is significant and occurs as an unintended consequence of cardiothoracic surgery affecting more than 30% of coronary artery bypass patients and up to 60% of patients who undergo a combination valve replacement and bypass procedure.
Symphony’s CEO Raymond Cohen highlighted the need for improved treatments of AF. “Cardiologists are virtually unanimous in their view that a prophylactic approach that prevents post-op AF is highly desirable and, moreover, that the current approach towards post-op AF treatment, which typically involves significant doses of pharmacologics, is, at best, inadequate and ineffective,” he said.
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