Orchestra BioMed (OBIO) said Tuesday the US Food and Drug Administration has given breakthrough device designation for its atrioventricular interval modulation, or AVIM, therapy to manage hypertension.
The designation is for an implantable device, such as a pacemaker, to deliver AVIM therapy in patients with increased 10-year atherosclerotic cardiovascular disease risk, preserved left ventricular systolic function, and uncontrolled hypertension, the company said.
The therapy, which is being evaluated in a pivotal study in collaboration with Medtronic (MDT), is also for people with intolerance to anti-hypertensive drugs, the company added.
As part of its collaboration with Medtronic, Orchestra said Medtronic holds the right of first negotiation to expand their licensing agreement to include global rights to commercialize AVIM therapy.
Shares of Orchestra were down more than 4% in recent trading.
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