SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular Ultrasound (TIVUS™) System to treat a variety of hypertensive disorders, announced that on May 30th 2022 the first patient was treated with its Renal Artery Denervation TIVUS™ technology, as part of the recently FDA IDE-approved Pilot study to treat Hypertension (the REDUCED1 study).
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The procedure was successfully performed with TIVUS™ at the Kaplan Medical Center by Professor Michael Jonas, Principal Investigator of the REDUCED1 study, who commented: “We were able to use the TIVUS catheter to rapidly and efficiently perform UltraSound based renal denervation in our patient suffering from uncontrolled HTN. TIVUS’s catheter excellent ease of use and its ability to denervate at significant depth of the perivascular space allowed for a short, simple and straightforward procedure. We will closely follow our patient and look forward to continuing enrolment in this exciting trial.”
Renal Denervation with TIVUS™ is a minimally invasive procedure that uses high-frequency non-focused Ultra-Sound energy to ablate nerves in the renal artery. This causes a reduction in the nerve activity, which may decrease blood pressure. This procedure is designed for patients who suffer from resistant hypertension.
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, 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. We are genuinely happy for this important step forward. There is a lack of effective therapeutic solutions for these patients” says Christian Spaulding, CMO, SoniVie LTD.
“This procedure represents a great fulfilment for SoniVie team, whose expertise and achievements have been focusing on developing TIVUS™ technology for the Renal Denervation indication, both providing a promising treatment to the hypertensive patient and a high performing, easy to use device to the physician”, says Tomaso Zambelli, CEO, SoniVie LTD.