Israeli medical device company SoniVie announced on Tuesday that it has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for their device to treat patients with pulmonary arterial hypertension (PAH).
The device, called the Therapeutic Intra-Vascular Ultrasound (TIVUS) System, is an ultrasound catheter that is inserted into the pulmonary artery during a right heart catheterization procedure. It is designed to ablate nerves associated with disease activity without damaging the vessel walls or the adjacent tissues to improve clinical outcomes.
“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,” Lewis Rubin, MD, 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, says in a statement.
“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,” says Rubin.
Breakthrough Device Designation is granted to certain medical devices and device-led combination products that provide an effective treatment for life-threatening or irreversibly debilitating diseases.
The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and marketing authorization.
“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,” says Chuck Carignan, MD, chief executive officer at SoniVie.