FDA Grants Breakthrough Device Designation for the TIVUS Renal Artery Denervation System

SoniVie, an Israeli company developing the Therapeutic Intra-Vascular Ultrasound (TIVUS) System to treat a variety of hypertensive disorders, announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The TIVUS System for renal artery denervation treats resistant hypertension, which is defined as blood pressure that remains above 140/90 mmHg despite use of three antihypertensive medications of different classes at the best tolerated doses.

SoniVie, an Israeli company developing the Therapeutic Intra-Vascular Ultrasound (TIVUS) System to treat a variety of hypertensive disorders, announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

December 9, 2020 — SoniVie, an Israeli company developing the Therapeutic Intra-Vascular Ultrasound (TIVUS) System to treat a variety of hypertensive disorders, announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The TIVUS System for renal artery denervation treats resistant hypertension, which is defined as blood pressure that remains above 140/90 mmHg despite use of three antihypertensive medications of different classes at the best tolerated doses, one of which must be a diuretic.

Millions of people world-wide suffer from resistant hypertension which substantially increases the risk of heart attack, stroke and kidney failure.

Breakthrough Device Designation is a special regulatory status granted to medical devices 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 FDA premarket approval, 510(k) clearance and de novo marketing authorization. The company previously received Breakthrough Device Designation for the TIVUS System in the treatment of pulmonary arterial hypertension (PAH) in September 2019.

“We are excited about moving the TIVUS System into therapeutic areas beyond PAH and believe that the technology has broad utility in a variety of serious health conditions,” said Chuck Carignan, M.D., chief executive officer at SoniVie. “A growing body of clinical evidence suggests that our ultrasound-based denervation technology may provide clinical benefit in the treatment of diseases that lack optimal medical management, including resistant hypertension. We believe that the TIVUS System can work synergistically with existing treatments to potentially improve clinical outcomes.”

The company also announced that it has acquired the remaining intellectual property and other assets related to the use of the TIVUS System from Cardiosonic. SoniVie had previously licensed technology related to the use of TIVUS specifically in the treatment of PAH.

With this acquisition, SoniVie’s TIVUS procedure becomes the only platform denervation technology with active development programs in multiple therapeutic areas: pulmonary artery denervation (PADN) for pulmonary hypertension and renal artery denervation (RDN) for resistant hypertension along with other potential applications.

Dr. Carignan added, “With Breakthrough Device Designation in two indications and control of the intellectual property and other assets related to the use of the TIVUS System in multiple indications, we have a strong competitive advantage as we work to advance targeted denervation as a therapeutic approach that can provide best-in-class outcomes to patients.”

Renal denervation with the TIVUS System is a minimally invasive procedure that uses high-frequency non-focused ultrasound to ablate nerves in the renal artery. This causes a reduction in the nerve activity, which decreases blood pressure. This procedure is designed for patients who suffer from resistant hypertension. Cardiosonic previously conducted two clinical trials of RDN in patients with resistant hypertension using an earlier version of the TIVUS System, and these trials showed excellent feasibility in lowering blood pressure out to six months. Cardiosonic also received a CE Mark for the earlier version of the system.

“With our very encouraging clinical data in PAH, and the excellent published data from the TIVUS II study in renal artery denervation conducted by Cardiosonic, we may be able to offer a platform solution that can change the lives of millions of people worldwide, while reducing costs to healthcare systems,” said Dr. Irit Yaniv, chair of SoniVie and founding partner and CEO of Almeda Ventures.

Building on the promising RDN clinical trials that Cardiosonic previously conducted, SoniVie expects to initiate new clinical trials of its current TIVUS System in patients with resistant hypertension in late 2021. In October 2020, the company announced that it had received IDE approval for its pivotal trial of the TIVUS System in patients with PAH (NCT04570228), and it currently anticipates initiating enrollment in the study in early 2021.

For more information: sonivie.com