Orchestra BioMed Holdings has announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for atrioventricular interval modulation (AVIM) therapy.
The breakthrough device designation is for an implantable system (i.e. a pacemaker) to deliver AVIM therapy using conduction system pacing to reduce blood pressure in patients with increased ten-year atherosclerotic cardiovascular disease (ASCVD) 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 over 7.7 million patients in the USA that meet the criteria for the breakthrough device designation for AVIM therapy. AVIM therapy is currently being evaluated under an FDA investigational device exemption (IDE) in the BACKBEAT global pivotal study which is being conducted by Orchestra BioMed in collaboration with Medtronic.
The BACKBEAT pivotal study is enrolling pacemaker-indicated patients with uncontrolled hypertension despite the use of anti-hypertensive medication, a key subpopulation under the BDD for which Orchestra BioMed believes AVIM therapy may offer optimal clinical benefit.
“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,” commented David Hochman, chairman and chief executive officer 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 recognises 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 maximise 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,” said Robert C Kowal, vice president and general manager of Cardiac Pacing Therapies within the Medtronic 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. Medtronic is committed to collaborating with Orchestra BioMed to advance this innovative, investigational therapy through the BACKBEAT global pivotal study.”
