SoniVie Gains IDE Approval for THRIVE Pivotal Trial of Tivus RDN System

July 24, 2024—SoniVie announced that the FDA recently approved an investigational device exemption for the THRIVE pivotal study of the company’s Tivus therapeutic intravascular ultrasound system for renal denervation (RDN) therapy in patients with resistant hypertension. THRIVE is an international, multicenter, randomized, double-blind, sham-controlled study designed to demonstrate the adjunctive effectiveness and safety of RDN with the Tivus system.

Additionally, the company announced that results from its REDUCED-1 pilot study of RDN with the Tivus system were presented by James Zidar, MD, who is from the University of North Carolina in Raleigh, North Carolina. Additionally, a case presentation of the first-in-human treatment with the 4F, rapid-exchange Tivus radial access catheter was delivered by Professor Michael Jonas, MD, from Kaplan, Israel. Both presentations were made at EuroPCR, which was held May 14-17 in Paris, France.

According to SoniVie, RDN with Tivus uses a high-frequency, nonfocused ultrasound energy catheter that does not anchor to the vessel wall during treatment to ablate nerves in the surrounding tissue located along the renal arteries, thereby reducing sympathetic activity, which lowers blood pressure.

In the THRIVE pivotal trial, patients will be maintained off-antihypertensive medications for a 4-week wash-out period before the RDN or sham procedure and 2 months after the procedure. At 2 months after the procedure, patients with uncontrolled hypertension will be put back on antihypertensive medication according to a medication escalation protocol. At 6 months, unblinding will be performed and uncontrolled sham patients can crossover to Tivus, advised SoniVie.

THRIVE is led by a Global Steering Committee composed of Ajay Kirtane, MD, from Columbia University Medical Center in New York, New York; Michel Azizi, MD, from George Pompidou Hospital in Paris, France; and Felix Mahfoud, MD, from the University of Basel in Basel, Switzerland.

The REDUCED-1 study’s 3-month primary efficacy data were delivered by Dr. Zidar at EuroPCR. The study was composed of 40 patients with 25 in the United States and 15 in Israel.

As summarized in the company’s press release, the REDUCED-1 data showed an average -12.0 mmHg reduction in daytime ambulatory systolic blood pressure (ASBP) comparing baseline to 3-month with 78.4% of patients being responders (≥5-mm reduction in daytime ASBP).

The responder ASBP 3-month average reduction was -16.2mmHg. No device-related adverse events were reported in the 1-month primary safety endpoint analysis, and efficacy data are sustained at 6-month follow-up, stated the company.

The company’s press release noted that the EuroPCR panel of discussants and RDN experts commented, “This is the first no-touch RDN device that is not required to be in contact with the renal artery vessel wall, which is unique as the other RDN technologies to date require contact.”

SoniVie, which is based in Rehovot, Israel, and Minneapolis, Minnesota, advised that it has active development programs for Tivus in three therapeutic areas: renal artery denervation for resistant hypertension; pulmonary artery denervation for pulmonary hypertension; and total lung denervation for chronic obstructive pulmonary disease with chronic bronchitis.