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 7.7m patients in the US who meet these criteria.
Pacemaker for hypertension
A double-blind, randomised 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 six 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 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.
Avi Fischer, MD, senior vice president of medical affairs and innovation at Orchestra BioMed, said: “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 programme is intended to accelerate the development and provide priority review of new medical technologies with the potential to significantly improve outcomes for patients with serious or life-threatening conditions.
Medscape article – A Pacemaker to Control BP Gets FDA Breakthrough Designation (Open access)
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