Orchestra BioMed’s hypertension treatment is the latest medical device to earn the FDA’s breakthrough designation. The device is an atrio-ventricular interval modulation therapy, meaning it uses a pacing algorithm to actively lower blood pressure.
By granting Orchestra’s product a breakthrough device status, the FDA is putting it on a fast track program — with the aim that patients with uncontrolled hypertension can hopefully access a novel treatment sooner.
Millions of people across the world struggle to control their blood pressure, especially older adults and those already living with cardiovascular disease, pointed out David Hochman, Orchestra’s founder and CEO.
“One of the biggest challenges is adherence to daily medications — but even when patients comply with taking their prescribed medications, many are still unable to reach their target blood pressure. Uncontrolled hypertension remains the leading global risk factor for death, significantly increasing the likelihood of heart attacks, strokes and heart failure,” he stated.
Orchestra’s device seeks to address this unmet need by providing an immediate and sustained reduction in blood pressure — without adding another daily medication to a patient’s routine.
The device is a firmware enhancement added to standard, implantable pulse generators like pacemakers. This firmware programs the pacemaker to alternate between shorter and longer intervals between heartbeats — a pattern that lowers blood pressure, Hochman explained.
“The short AV intervals reduce cardiac preload, immediately lowering blood pressure. The intermittent longer AV intervals modulate the autonomic nervous system response (the baroreceptor reflex) and reduce afterload to sustain the blood pressure reduction,” he said.
Orchestra is currently conducting a clinical trial for its device in partnership with medical device giant Medtronic It is enrolling pacemaker-indicated patients with uncontrolled hypertension despite the use of blood pressure control medication.
The company has a strategic partnership with Medtronic for the development and commercialization of its product — and the deal stipulates that if the device’s indication ever expands to help patients who don’t need a pacemaker, Medtronic gets the first chance to negotiate a global commercialization deal with Orchestra.
Currently, Orchestra is the only company publicly known to be developing atrioventricular interval modulation therapy. But of course, there are other treatments and therapies doctors are prescribing to help patients with uncontrolled hypertension, including the Symplicity procedure.
This procedure, also known as renal denervation, is a minimally invasive treatment that uses radiofrequency energy to disrupt overactive nerves near the kidneys, thereby lowering high blood pressure.
Both Orchestra’s device and procedures like Symplicity are designed to help lower blood pressure, but they do so in different ways, Hochman noted.
“We believe that managing hypertension effectively will require a flexible, comprehensive treatment toolkit — one that allows physicians to tailor treatment to each patient’s unique needs. That’s why we’re working closely with our collaborators at Medtronic to help build a continuum of care for device-based hypertension management. Ultimately, we view AVIM therapy and Symplicity as complementary technologies that can expand the range of options available to clinicians and patients,” he remarked.
Orchestra, founded in 2018, is headquartered in New Hope, Pennsylvania, with additional operations in Fort Lauderdale, New York City and Europe.
Photo: Magicmine, Getty Images
