FDA sees potential in new pacemaker-guided hypertension therapy
Orchestra BioMed Holdings, a Pennsylvania-based healthcare technology company, has received the FDA’s breakthrough device designation for its atrioventricular interval modulation (AVIM) therapy designed to provide immediate relief to high-risk patients with uncontrolled hypertension.
The FDA’s breakthrough devices program is designed to help medical devices make it through the approval process faster than they would otherwise. The agency’s representatives work directly with the manufacturer, for example, and any submissions are prioritized.
Additional details about Orchestra BioMed’s AVIM technology
The company’s AVIM therapy is delivered using a standard implantable dual-chamber pacemaker system that uses conduction system pacing to reduce and maintain the patient’s blood pressure. It works automatically, without requiring patients to take any additional steps.
Image courtesy of Orchestra BioMed Holdings.
Orchestra BioMed’s business model involves forming risk-reward sharing partnerships with a variety of medical device companies. For this AVIM therapy, for example, the group is working closely with Medtronic on both the development and commercialization sides of the equation. Medtronic is also assisting Orchestra BioMed with the BACKBEAT pivotal study, which is currently enrolling pacemaker-indicated patients who could potentially benefit from treatment.
Medtronic is Orchestra BioMed’s exclusive partner when it comes to commercializing AVIM therapy to pacemaker-indicated patients with a heightened 10-year risk of atherosclerotic cardiovascular disease and hypertension that persists despite the use of anti-hypertensive medications. Medtronic also holds the right of first negotiation when it comes to patients who do not have an indication for a pacemaker.
“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,” David Hochman, chairman and CEO of Orchestra BioMed, said in a statement. “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 … We are committed to working closely with the FDA, Medtronic and the clinical community to maximize the impact of AVIM therapy.”
“Hypertension remains a significant global public health challenge that is especially relevant to the pacemaker population as the most common comorbidity in these patients,” added Robert C. Kowal, MD, PhD, vice president and general manager of cardiac pacing therapies within Medtronic’s 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.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.