Sam Brusco, Associate Editor06.20.22
Israeli firm SoniVie has earned U.S. Food and Drug Administration (FDA) approval for its REDUCED1 pilot study to treat resistant hypertension patients with renal artery denervation using TIVUS, the company’s ultrasound ablation system.
Resistant hypertension is defined as blood pressure higher than 140/90 mmHg despite use of three antihypertensive medications of different classes at the best tolerated doses.
"We are very pleased that FDA has approved the REDUCED1 (Renal Denervation using Ultrasonic Catheter EmitteD energy) study. Sites initiation has started, and many clinical teams have responded very favorably about participating to the study. There is a significant number of patients that may benefit from our technology and we are genuinely happy for this important step towards the introduction of TIVUS in the US. There is a lack of effective therapeutic solutions for patients suffering from resistant hypertension, and physicians are looking forward to a safe, effective and easy to use device treatment," Christian Spaulding, CMO of SoniVie told the press.
The minimally invasive procedure leverages high-frequency non-focused ultrasound energy to ablate nerves in the renal artery. The reduction in nerve activity can decrease blood pressure.
"This is a significant U.S. regulatory milestone for SoniVie, starting the feasibility study using the ultrasound ablation platform in the U.S. for the Renal Denervation indication. This is a major step and priority in the company's history," said Tomaso Zambelli, CEO of SoniVie.
Resistant hypertension is defined as blood pressure higher than 140/90 mmHg despite use of three antihypertensive medications of different classes at the best tolerated doses.
"We are very pleased that FDA has approved the REDUCED1 (Renal Denervation using Ultrasonic Catheter EmitteD energy) study. Sites initiation has started, and many clinical teams have responded very favorably about participating to the study. There is a significant number of patients that may benefit from our technology and we are genuinely happy for this important step towards the introduction of TIVUS in the US. There is a lack of effective therapeutic solutions for patients suffering from resistant hypertension, and physicians are looking forward to a safe, effective and easy to use device treatment," Christian Spaulding, CMO of SoniVie told the press.
The minimally invasive procedure leverages high-frequency non-focused ultrasound energy to ablate nerves in the renal artery. The reduction in nerve activity can decrease blood pressure.
"This is a significant U.S. regulatory milestone for SoniVie, starting the feasibility study using the ultrasound ablation platform in the U.S. for the Renal Denervation indication. This is a major step and priority in the company's history," said Tomaso Zambelli, CEO of SoniVie.