FDA Awards Breakthrough Device Designation to AVIM Therapy for Hypertension

The US Food and Drug Administration (FDA) has granted Breakthrough Device designation to an implantable pacemaker system delivering atrioventricular interval modulation (AVIM) therapy in patients with elevated atherosclerotic cardiovascular disease (ASCVD) risk and uncontrolled hypertension.1

Announced by Orchestra BioMed Holdings, Inc., on April 22, 2025, the AVIM therapy is labeled under an FDA investigational device exemption in the global, pivotal BACKBEAT trial, conducted by the company in collaboration with Medtronic.

“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, MD, PhD, vice president and general manager of cardiac pacing therapies at Medtronic’s 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.”1

The FDA’s Breakthrough Device designation is designed to expedite the development and offer priority review to medications or technologies that could significantly benefit outcomes in patients with serious or life-threatening conditions. Eligibility for this designation requires the breakthrough technology to provide more effective treatment or diagnosis of an irreversibly debilitating condition, with no approved alternatives and a significant advantage over existing treatment options.2

Orchestra BioMed received this designation for an implantable system to deliver AVIM therapy by conduction system pacing to substantially lower blood pressure in patients with increased ten-year ASCVD risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite use of anti-hypertensive medications or intolerance to their use.

Initial data from the double-blind, randomized MODERATO II pilot study found patients treated with AVIM therapy reported net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office SBP at 6 months, compared with control. AVIM therapy also reported improvement in cardiac function and hemodynamics.3

The BACKBEAT trial will assess the safety and efficacy of AVIM therapy in lowering blood pressure in dual-chamber cardiac pacemaker-indicated patients with above-target systolic blood pressure, despite the use of anti-hypertensive medication. Orchestra BioMed pointed to these individuals as a key subpopulation for whom AVIM therapy may provide significant clinical benefit.1

The company estimated that more than 7.7 million people in the US could meet the criteria for the Breakthrough Device designation for AVIM therapy.

Aside from regulatory acceleration, the designation may also provide favorable reimbursement pathways, including eligibility for incremental inpatient reimbursement under Center for Medicare & Medicaid Services programs. These could lead to more timely access to breakthrough technologies and support provider adoption and patient access.

Orchestra BioMed has a strategic collaboration with Medtronic for the development and commercialization of AVIM therapy for uncontrolled hypertension in pacemaker-indicated patients. In the release, the company announced its commitment to working closely with the FDA, Medtronic, and the clinical community to widen the potential impact of AVIM therapy.

“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,” said David Hochman, chairman and chief executive officer of Ochestra BioMed. “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.”1

References

1. Orchestra biomed receives FDA Breakthrough device designation for avim therapy. Orchestra BioMed. April 22, 2025. Accessed April 22, 2025. https://investors.orchestrabiomed.com/news-releases/news-release-details/orchestra-biomed-receives-fda-breakthrough-device-designation.

2. Center for Devices and Radiological Health. Breakthrough devices program. U.S. Food and Drug Administration. Accessed April 22, 2025. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program.

3. Kalarus Z, Merkely B, Neužil P, et al. Pacemaker-Based Cardiac Neuromodulation Therapy in Patients With Hypertension: A Pilot Study. J Am Heart Assoc. 2021;10(16):e020492. doi:10.1161/JAHA.120.020492