FDA Grants Breakthrough Device Designation to Orchestra BioMed’s AVIM Treatment

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

The designation applies to an implantable system, specifically a pacemaker that delivers AVIM therapy using conduction system pacing. This system is intended to help reduce blood pressure in patients who are at an increased ten-year risk of atherosclerotic cardiovascular disease (ASCVD), have preserved left ventricular systolic function, and suffer from uncontrolled hypertension. These patients may either not respond adequately to anti-hypertensive medication or may be intolerant to it.

The Breakthrough Device Designation aims to speed up the development and review of medical technologies that could significantly improve treatment for serious or life-threatening conditions. To qualify, devices must show potential for more effective treatment and meet additional criteria such as representing a breakthrough technology, lacking approved alternatives, or providing notable benefits over existing options.

Receiving the designation may also offer potential advantages in reimbursement. These include eligibility for the New Technology Add-on Payment (NTAP) for inpatient care and Transitional Pass-Through (TPT) payments for outpatient services, both under the U.S. Centers for Medicare & Medicaid Services (CMS). These mechanisms are designed to support faster access to breakthrough therapies and help with wider adoption among healthcare providers.