FDA Breakthrough Device Designation for SoniVie’s TIVUS Pulmonary Arterial Hypertension System

Pulmonary Arterial Hypertension (PAH) treatment specialist SoniVie, has been granted Breakthrough Device Designation from the U.S. FDA for the Therapeutic Intra-Vascular Ultrasound (TIVUS) System in patients with PAH.

Background

SoniVie is a medical device company developing the TIVUS™ Ultrasonic Denervation System as an innovative system for the treatment of pulmonary hypertension including pulmonary arterial hypertension (PAH). Pulmonary hypertension is a disease affecting millions of patients in the United States and Europe. The TIVUS procedure is straightforward, and has shown excellent results in first-in-human clinical trials in Group 1 PAH patients. The company has also launched a clinical trial of TIVUS in Group 2 PH patients.

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.

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.

Clinician comments

“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.”

Company comments

“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, Chief Executive Officer 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.

Source: PR Newswire

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