Orchestra BioMed Holdings Inc. has announced that its AVIM therapy has been granted Breakthrough Device Designation by the FDA. This designation is based on the significant unmet need among patients and the innovative potential of the AVIM therapy, as demonstrated by clinical results to date. The designation aims to streamline the regulatory process, providing potential pathways for securing higher reimbursement for AVIM-enabled devices in the future. This regulatory milestone supports Orchestra BioMed's goal of expanding beyond its current focus on pacemaker patients to address a broader population of high-risk hypertensive individuals. The FDA's designation is a testament to the therapy's promise and could accelerate its reach to millions of patients worldwide.
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