April 22, 2025 — Orchestra BioMed Holdings, a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, has announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation (BDD) for atrioventricular interval modulation (AVIM) therapy.
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 estimates there are over 7.7 million patients in the U.S. that meet the criteria for the BDD for AVIM therapy. AVIM therapy is currently being evaluated under an FDA investigational device exemption (IDE) in the BACKBEAT global pivotal study which is being conducted by Orchestra BioMed in collaboration with Medtronic. The BACKBEAT pivotal study is enrolling pacemaker-indicated patients with uncontrolled hypertension despite the use of anti-hypertensive medication, a key subpopulation under the BDD for which Orchestra BioMed believes AVIM therapy may offer optimal clinical benefit.
“We are delighted to have received FDA Breakthrough Device Designation for AVIM therapy which has the potential to offer a differentiated, advantageous solution for hypertension management in a broad population,” said David Hochman, Orchestra Biomed's chairman and CEO. “Patients at higher risk for mortality and morbidity associated with high blood pressure are the core of the population we are actively enrolling in the BACKBEAT global pivotal study of hypertensive pacemaker-indicated patients in collaboration with Medtronic. The FDA Breakthrough Device Designation recognizes the potential of this unique therapy to benefit a significantly expanded number of patients who are not indicated for a pacemaker but who also have uncontrolled hypertension and increased cardiovascular risk. We are committed to working closely with the FDA, Medtronic and the clinical community to maximize the impact of AVIM therapy.”
The FDA Breakthrough Devices Program, is designed to expedite the development and provide priority review of innovative medical technologies that have the potential to significantly improve outcomes for patients with serious or life-threatening conditions. To be eligible for this designation, a device must demonstrate the potential to provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating condition. In addition, the device must meet at least one of these criteria: it must represent breakthrough technology, have no approved or cleared alternatives, offer significant advantages over existing options, or be determined by the FDA to be in the best interest of patients.
Beyond regulatory acceleration, the Breakthrough designation may also support favorable reimbursement pathways, including eligibility for incremental inpatient reimbursement through the New Technology Add-on Payment (NTAP) and outpatient Transitional Pass-Through payments (TPT) under the Center for Medicare & Medicaid Services (CMS) programs. These mechanisms may help facilitate more timely access to breakthrough technologies while supporting provider adoption and patient access.
“We are very pleased that AVIM therapy received Breakthrough Device Designation, a recognition of the potential of AVIM therapy to address unmet needs in hypertension management,” said Robert C. Kowal, M.D., Ph.D., vice president/general manager of Cardiac Pacing Therapies within the Medtronic Cardiac Rhythm Management operating unit. “Hypertension remains a significant global public health challenge that is especially relevant to the pacemaker population as the most common comorbidity in these patients. Medtronic is committed to collaborating with Orchestra BioMed to advance this innovative, investigational therapy through the BACKBEAT global pivotal study.”
Orchestra BioMed has a strategic collaboration with Medtronic for development and commercialization of AVIM therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. Under the terms of the existing collaboration agreement, Medtronic holds the right of first negotiation to expand its licensing agreement with Orchestra BioMed to obtain global rights to commercialize AVIM therapy for the treatment of uncontrolled hypertension in patients that do not have an indication for a pacemaker.
December 01, 2025 
