FDA Grants Breakthrough Device Status to SoniVie’s TIVUS System for PAH

The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough device to SoniVie’s Therapeutic Intra-Vascular Ultrasound (TIVUS) System for the treatment of people with pulmonary arterial hypertension (PAH).

Similar to breakthrough therapy, the designation of breakthrough device is given to medical equipment that provides significant advantages over currently available options. It is intended to accelerate the development, review, and approval of devices that have been designed to treat irreversibly debilitating or life-threatening conditions.

“There are no approved medical device treatment options for PAH, only medications. The TIVUS System has been shown in early clinical studies to stabilize or improve pulmonary vascular resistance [a measure of heart strain] in PAH patients, suggesting that it could offer significant incremental benefits to a patient population that has a five-year mortality greater than 40 percent,” Lewis Rubin, emeritus professor of medicine at the University of California San Diego School of Medicine and adjunct professor of medicine at Columbia University College of Physicians and Surgeons, said in a press release.

TIVUS features a special catheter that produces ultrasound waves once it is inserted into the patient’s pulmonary artery — the artery that connects the heart to the lungs — during a right heart catheterization procedure. By doing so, TIVUS destroys certain nerves that constrict the patient’s arteries — without injuring the blood vessel walls or nearby tissues — thus improving the individual’s quality of life.

Right heart catheterization is commonly used to diagnose PAH as it measures the pressure in the pulmonary arteries and shows the heart’s capacity to pump blood.

SoniVie, formerly known as Cardiosonic, presented preliminary data in May 2019 on the safety, performance, and early efficacy of TIVUS in people with PAH. Those data — early findings from the TROPHY1 trial — were presented during the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR), held in Paris.

The TReatment Of Pulmonary HYpertension 1 trial (NCT02835950 and NCT02516722) enrolled a total of 23 participants who showed marked PAH symptoms and substantial limitations in physical activity (functional class III). All participants were on an established regimen of dual-oral therapy, after undergoing treatment with TIVUS.

Preliminary data showed no evidence of serious adverse events occurring due to the use of TIVUS, or of the procedure of nerve elimination itself. In addition, a few months after the procedure, investigators reported significant improvements in pulmonary vascular resistance, mean pulmonary artery pressure, patients’ exercise capacity, and daily activity.

Based on these findings, researchers believe that the TIVUS system, and the procedure of nerve elimination, may safely reduce heart strain and improve exercise tolerance in people with PAH.

The company already is planning to launch a new pivotal trial next year to continue to explore the clinical benefits of TIVUS.

“The TIVUS System qualifies as a breakthrough device because it is the first of any potential therapeutic product for PAH to use high-frequency non-focused ultrasound and can address a significant unmet need in this patient population,” said Chuck Carignan, MD, CEO of SoniVie.

“In addition to providing priority review for the TIVUS regulatory submission to the FDA, this breakthrough device designation will also provide reimbursement benefits under a new Centers for Medicare and Medicaid Services (CMS) alternative new technology add-on payment once the system is commercially available,” Carignan added. “We believe that, if shown to be effective, these benefits will help PAH patients gain access to a treatment option that has the potential to improve outcomes for this life-threatening disease.”

The new technology payment model increases add-on payment up to 65% and removes the need for a medical device to demonstrate that it significantly improves the efficiency of the diagnosis or treatment of its target patients compared to other products currently available on the market. Any medical devices that receive the designation of breakthrough device, and that are under CMS’ Inpatient Prospective Payment System for the fiscal year of 2020 may benefit from this new rule.

This means that once a device has been approved, manufacturers will have two years to provide real-world evidence demonstrating its clinical benefits over other products.