SoniVie TIVUS System Receives FDA Breakthrough Device Designation

SoniVie, an Israeli company developing a system for the treatment of PAH, today announced that it has been granted Breakthrough Device Designation from the 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.”
 
Breakthrough Device Designation is granted to certain medical devices and device-led combination products that provide a more 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 De Novo marketing authorization.
 
TIVUS is a dedicated therapeutic ultrasound catheter to enhance the treatment of PAH and 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 quality of life and clinical outcomes. In the United States alone there are more than 50,000 patients suffering from PAH.
 
“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 at 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 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.” SoniVie expects to initiate a pivotal trial of the TIVUS System in 2020.
 
In August 2019 the Centers for Medicare and Medicaid Services finalized its proposal to create an alternative new technology add-on pathway for medical devices with Breakthrough Device Designation under its Inpatient Prospective Payment System for fiscal year 2020. The new model increases the add-on payment for such devices to 65% and also removes the requirement for a device to demonstrate prior to approval that it substantially improves diagnosis or treatment compared with marketed products. Under the rule, manufacturers have two years post-approval to provide real-world evidence that demonstrates substantial clinical improvement over currently marketed products.
 
In May 2019, Sonivie presented data from the TROPHY1 (TReatment Of Pulmonary HYpertension 1) trial (NCT02835950 and NCT02516722) at EuroPCR 2019. The trial enrolled 23 Functional Class III PAH patients who were on an established regimen of dual-oral medical therapy. The study found no serious adverse events related to the device or procedure and demonstrated improvements in pulmonary vascular resistance, mean pulmonary artery pressure, six-minute walk distance, daily activity, and European Society of Cardiology (ESC) low-risk indicators compared with baseline assessments. The study authors conclude that the TROPHY1 results support the safety of pulmonary denervation using TIVUS in this patient population and suggest that this procedure may improve hemodynamics and exercise tolerance in patients with PAH.