News | April 28, 2014

Cardiosonic Received CE Mark for TIVUS Ablative Catheter Device

Cardiosonic Inc CE mark TIVUS ablative catheter renal denervation hypertension

April 28, 2014 — Cardiosonic Ltd. announced CE marking of its TIVUS (therapeutic intravascular ultrasound) ablative catheter device.

The core of the company's technology is a miniaturized ultrasonic transducer, located at the tip of a flexible catheter and capable of emitting ultrasonic waves, which creates controllable levels of heat for selective tissue ablation.

The first application of the TIVUS catheter is renal denervation (RDN) for the treatment of resistant hypertension.

Animal testing has shown that the TIVUS non-focused ultrasonic energy penetrates the artery wall and causes nerve ablation at a depth range of 0.5 mm to 10 mm, enabling a more complete nerve ablation than radio frequency energy, which damages the vessel wall and penetrates half as deep as TIVUS.

The TIVUS system has been evaluated in two multi-center clinical trials in Europe, Australia and Israel. The TIVUS II trial enrolled 25 patients and has shown an average reduction in blood pressure versus baseline of 38 mmHg. Benny Dilmoney, the company's CEO, commented: "The impressive drop in blood pressure is due to a high level of renal nerves ablation, made possible by the fact that ultrasonic heat waves penetrate much deeper into the artery tissues than any other ablation methods in use, mainly RF."

Cardiosonic now intends to carry out the TIVUS III study, which will further assess the TIVUS technology in a controlled manner. Dilmoney expressed confidence that the results obtained in the TIVUS II study will be replicated in the planned follow-up TIVUS III study.

Other applications of the company's technology include the treatment of pulmonary hypertension, COPD, asthma and atrial fibrillation (AF). The company has completed encouraging preliminary animal work in all of these areas.

For more information: www.cardiosonic.co.il


Related Content

News | Hypertension

June 28, 2024 — AstraZeneca has set out a new ambition for Healthy Heart Africa, its flagship health equity initiative ...

Home June 28, 2024
Home
News | Hypertension

June 6, 2024 — A substantial portion of young athletes are at risk of hypertension, according to a study presented at ...

Home June 06, 2024
Home
News | Hypertension

May 16, 2024 — People were more likely to develop a type of treatment-resistant hypertension when they experienced ...

Home May 16, 2024
Home
News | Hypertension

May 8, 2024 — Ultrasound could one day complement or even replace drugs to treat diseases. Bioelectronic medicine ...

Home May 08, 2024
Home
News | Hypertension

April 1, 2024 — Sleeping fewer than seven hours is associated with a higher risk of developing high blood pressure over ...

Home April 01, 2024
Home
News | Hypertension

March 18, 2024 — The Smidt Heart Institute at Cedars-Sinai recently became one of four institutions in the U.S. and the ...

Home March 18, 2024
Home
News | Hypertension

February 27, 2024 — Aria CV, Inc, a developer of medical devices treating pulmonary hypertension, today announced the ...

Home February 27, 2024
Home
News | Hypertension

February 14, 2024 — The replacement of regular salt with a salt substitute can reduce incidences of hypertension, or ...

Home February 14, 2024
Home
News | Hypertension

January 19, 2024 — Orchestra BioMed, a biomedical company accelerating high-impact technologies to patients through risk ...

Home January 19, 2024
Home
News | Hypertension

December 13, 2023 —Infusions of potentially therapeutic cells derived from the heart are safe for people with pulmonary ...

Home December 13, 2023
Home
Subscribe Now