FDA breakthrough device designation for its Therapeutic Intra-Vascular Ultrasound System for patients with pulmonary arterial hypertension.
The Therapeutic Intra-Vascular Ultrasound (TIVUS) System is a dedicated therapeutic ultrasound catheter that enhances the treatment of PAH, according to the company. It is inserted into the pulmonary artery during right heart catheterization and is designed to ablate nerves associated with PAH without damaging vessel walls and tissues.
“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,” CEO Chuck Carignan said in a press release.
“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 alternative new technology add-on payment once the system is commercially available. 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.”
Rosh-Haayin, Israel-based SoniVie plans to start a pivotal trial of the system in 2020.
“PAH is classified as a life-threatening or irreversibly debilitating disease because it is characterized by a progressive increase in pulmonary vascular resistance that leads to right-sided heart failure and death,”
Dr. Lewis Rubin, professor of medicine at UC San Diego and Columbia University College of Physicians and Surgeons, said. “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 in PAH patients, suggesting that it could offer significant incremental benefits to a patient population that has a five-year mortality greater than 40%.”