The US Food and Drug Administration (FDA) has given Breakthrough Device Designation to Orchestra BioMed for its atrioventricular interval modulation (AVIM) therapy for patients with uncontrolled hypertension.
AVIM is a pacing algorithm incorporated into dual-chamber pacemakers to treat hypertension. It delivers repeating sequences of shorter and longer atrioventricular delays,lowering blood pressure while simultaneously modulating the autonomic nervous system.
The Breakthrough Device Designation is for an implantable system — a pacemaker — to deliver AVIM therapy in patients with increased 10-year atherosclerotic cardiovascular disease 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 that there are more than 7.7 million patients in the US that meet these criteria.
A Pacemaker for Hypertension
“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, CEO of Orchestra BioMed.
A double-blind, randomized pilot study called MODERATO II showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure after 6 months compared with control patients.
Another pivotal trial run in collaboration with Medtronic, called BACKBEAT, is currently evaluating the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have been indicated for, and recently implanted with, a dual-chamber cardiac pacemaker.
“Hypertension remains a significant global public health challenge that is especially relevant to the pacemaker population as the most common comorbidity in these patients,” said Robert C. Kowal, MD, vice president of cardiac pacing therapies within the Medtronic Cardiac Rhythm Management operating unit. “Medtronic is committed to collaborating with Orchestra BioMed to advance this innovative, investigational therapy through the BACKBEAT global pivotal study.”
But AVIM therapy is designed to have broad clinical applicability beyond patients with hypertension who require a pacemaker. So, there are also plans to extend this approach to patients with uncontrolled hypertension who would not otherwise have a pacemaker.
“There are millions of patients without a pacemaker indication who have uncontrolled hypertension and are at increased cardiovascular risk who we believe may benefit from a device-based treatment like AVIM therapy,” said Avi Fischer, MD, senior vice president of medical affairs and innovation at Orchestra BioMed. “It is our long-term vision that AVIM therapy will be used as a potent, always-on, programmable therapy for hypertension that does not rely only on adherence to daily oral medications – one of the greatest challenges in current standard of care – regardless of whether there is an indication for a pacemaker.”
The FDA’s Breakthrough Device program is intended to accelerate the development and provide priority review of new medical technologies that have the potential to significantly improve outcomes for patients with serious or life-threatening conditions. It also allows AVIM-enabled devices to qualify for higher reimbursement from the Center for Medicare & Medicaid Services in the future.