Israeli medical device company SoniVie, announced on Sunday that it received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration for its REDUCED1 (Renal Denervation using Ultrasonic Catheter EmitteD energy) pilot study to treat resistant hypertension patients with renal artery denervation using its proprietary therapeutic intra-vascular ultra-sound system, or TIVUS.
Renal denervation with TIVUS is a minimally invasive procedure that uses high-frequency non-focused ultra-sound energy to burn away nerves in the renal artery. The TIVUS catheter is inserted into the pulmonary artery and selectively damages nerves afflicted by the disease without touching vessel walls or damaging adjacent tissues. This causes a reduction in the nerve activity, which decreases blood pressure and is meant for patients who suffer from resistant hypertension.
Resistant hypertension is defined as blood pressure that remains higher than 140/90 mmHg despite the use of three hierarchical classes of antihypertensive medications at their most appropriate tolerated doses. The condition affects millions of people around the world, increasing the risk of heart attack, stroke, and kidney failure.
Founded in 2014, SoniVie has developed a first-of-its-kind ultra-sound denervation platform with active programs establishing nuanced therapeutic solutions for pulmonary hypertension denervation, renal artery denervation for resistant hypertension, and lung denervation for obstructive pulmonary disease with chronic bronchitis.
“We are very pleased that the FDA has approved the REDUCED1 study,” said Christian Spaulding, chief marketing officer of SoniVie. “Sites initiation has started, and many clinical teams have responded very favorably about participating in 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,” he added. “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.”
“This is a significant US regulatory milestone for SoniVie, starting the feasibility study using the ultra-sound ablation platform in the US for the renal denervation indication,” said Tomaso Zambelli, CEO of SoniVie. “This is a major step and priority in the company’s history.”