Business
Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy
Breakthrough Device Designation (“BDD”) applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular riskBDD also encompasses pacemaker-indicated patients with uncontrolled hypertension who are the focus of the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)BDD status provides accelerated FDA engagement and reviews for AVIM therapy; it also supports
About this update from Orchestra Biomed Holdings, Inc.
[{"type":"image","alt":"Orchestra BioMed Holdings, Inc.","displaySize":"","headline":null,"caption":"Orchestra BioMed Holdings, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":97,"url":"https://media.zenfs.com/en/globenewswire.com/82bb98ef85c6f29f82627c7205a5e888"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/PcUBlKSAoIj3BMZ.626pqg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEzNjtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/82bb98ef85c6f29f82627c7205a5e888","width":300,"height":97}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"Breakthrough Device Designation (“BDD”) applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk","length":173,"tagName":"p"}]},{"val":[{"type":"text","content":"BDD also encompasses pacemaker-indicated patients with uncontrolled hypertension who are the focus of the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)","length":234,"tagName":"p"}]},{"val":[{"type":"text","content":"BDD status provides accelerated FDA engagement and reviews for AVIM therapy; it also supports potential pathways to secure higher reimbursement for AVIM-enabled devices in the future","length":182,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":589,"olType":false},{"type":"text","content":"NEW HOPE, Pa., April 22, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Breakthrough Device Designation (“BDD”) for atrioventricular interval modulation (“AVIM”) therapy.","length":426,"tagName":"p"},{"type":"text","content":"Specifically, the BDD is for an implantable system (i.e., a pacemaker) to deliver AVIM therapy using conduction system pacing to reduce blood pressure in patients with increased ten-year atherosclerotic cardiovascular disease (“ASCVD”) risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite the use of anti-hypertensive medications or in patients who may have intolerance to anti-hypertensive medications. Orchestra BioMed e...