Boston Scientific Acquires Medical Device Company SoniVie

(Rehovot, Israel), the developer of the TIVUS Intravascular Ultrasound System. The TIVUS system is an investigational technology designed to treat various hypertensive disorders by performing renal artery denervation (RDN) to reduce nerve activity surrounding blood vessels.

Hypertension, often linked to excessive activity in the sympathetic nervous system, is a major contributor to cardiovascular disease, which increases the risk of stroke, heart attack, and heart failure. While lifestyle changes and antihypertensive medications aimed at regulating the sympathetic nervous system – especially through renal nerve activity – are commonly prescribed, they often fall short in effectively controlling high blood pressure (BP). The TIVUS system is designed to perform RDN, targeting the renal nerves in the kidneys and offering an alternative or complementary therapy to these medications for better BP management. Unlike radiofrequency energy, ultrasound energy used by the TIVUS system has the potential to penetrate deeper into tissues, which could allow for quicker and more efficient nerve ablation.

The TIVUS system utilizes a catheter to deliver ultrasound energy that passes through the blood to reach the renal arteries, which supply blood to the kidneys, without attaching to the artery wall. This design allows continuous blood flow to cool the treatment area during the procedure. The ultrasound energy heats and ablates the nerve bundles outside the arteries, disrupting their ability to transmit signals and reducing the release of sympathetic hormones. This process leads to relaxation of the blood vessels and a decrease in blood pressure. In the previous year, SoniVie reported promising efficacy data from an IDE pilot trial of the TIVUS system conducted in the U.S. and Israel. The company has since launched the THRIVE global IDE pivotal trial for further evaluation of the device.

"Renal denervation for hypertension is an exciting medical advancement for the millions of patients it may help and is supported by positive results from contemporary clinical trials and ongoing research," said Lance Bates, senior vice president and president, Interventional Cardiology Therapies, Boston Scientific. "We believe the addition of the differentiated, ultrasound-based TIVUS system can complement our expansive interventional portfolio with a minimally invasive therapy for patients with hypertension and provides opportunity for future advancements in this space."

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Boston Scientific Corporation
SoniVie Ltd.