Orchestra BioMed Earns Breakthrough Status for AVIM Hypertension Therapy

Orchestra BioMed has been granted Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) for its atrioventricular interval modulation (AVIM) therapy.

The designation is for a pacemaker to deliver AVIM therapy using conduction system pacing to reduce blood pressure in those with increased ten-year atherosclerotic cardiovascular disease (ASCVID) risk, preserved left ventricular systolic function, and uncontrolled hypertension—despite using anti-hypertensive medications or in patients who may have intolerance to anti-hypertensive medications.

The company estimated there are over 7.7 million U.S. patients that meet the criteria for the BDD for AVIM therapy. AVIM therapy is currently being assessed under an investigational device exemption (IDE) in the BACKBEAT pivotal study, which Orchestra BioMed is conducting in partnership with Medtronic.

The collaboration with Medtronic gives Medtronic the right of first negotiation to expand its licensing deal with Orchestra BioMed to get global rights of commercialization for AVIM therapy to treat uncontrolled high blood pressure in patients without an indication for a pacemaker.

The study is enrolling pacemaker-indicated patients with uncontrolled high blood pressure despite using anti-hypertensive medication, a key subpopulation under the BDD. The FDA’s 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.

“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, chairman and CEO of Orchestra BioMed. “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.”

“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,” added Robert C. Kowal, MD, Ph.D., VP and GM of Medtronic’s Cardiac Pacing Therapies business. “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.”

In February, Orchestra BioMed presented data from its MODERATO II study of AVIM therapy on patients with diastolic dysfunction at the Technology and Heart Failure Therapeutics (THT) conference.