FDA Grants Orchestra BioMed Additional Breakthrough Device Designation for AVIM Therapy
Orchestra BioMed Holdings, Inc. has received a second Breakthrough Device Designation from the FDA for its AVIM Therapy aimed at patients with uncontrolled hypertension, including those indicated for a pacemaker. This designation supports both clinical and commercial strategies for the therapy. The AVIM Therapy, developed in collaboration with Medtronic, targets a significant patient population and aims to improve treatment outcomes for hypertension.
NEW HOPE, Pa., April 30, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced that the FDA has granted a second Breakthrough Device Designation (“BDD”) for AVIM Therapy specific to patients with uncontrolled hypertension despite the use of anti-hypertensive medications, and an indication for a pacemaker.