SoniVie Receives FDA Breakthrough Device Designation For The TIVUS System In The Treatment Of Pulmonary Arterial Hypertension (PAH)
SoniVie, an Israeli company developing a novel system for the treatment of PAH, today announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the Therapeutic Intra-Vascular Ultrasound (TIVUS) System in patients with PAH.
“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,” said Dr. Lewis Rubin, Emeritus Professor of Medicine, University of California, San Diego School of Medicine and Adjunct Professor of Medicine, Columbia University College of Physicians and Surgeons. “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 percent.”