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

January 17, 2023 — Arterial hypertension(AH), or high blood pressure, can be prevented if diagnosed pre-clinically on ...

Home January 17, 2023
Home
News | Hypertension

November 23, 2022 — In 2015, published findings from the landmark Systolic Blood Pressure Intervention Trial (SPRINT) ...

Home November 23, 2022
Home
News | Hypertension

November 21, 2022 — Mineralys Therapeutics, Inc., a private, clinical-stage biopharmaceutical company committed to ...

Home November 21, 2022
Home
News | Hypertension

November 21, 2022 — Mineralys Therapeutics, Inc., a private, clinical-stage biopharmaceutical company committed to ...

Home November 21, 2022
Home
News | Hypertension

November 9, 2022 — CinCor Pharma, Inc. announced the presentation today of Phase 2 data from its BrigHtn trial as part ...

Home November 09, 2022
Home
News | Hypertension

October 24, 2022 — CinCor Pharma, Inc. announced the publication of Phase 1 clinical data for baxdrostat, a highly ...

Home October 24, 2022
Home
News | Hypertension

October 5, 2022 — CinCor Pharma, Inc. (NASDAQ: CINC) today announced that the company will present Phase 2 data from its ...

Home October 05, 2022
Home
News | Hypertension

September 26, 2022 — ReCor Medical, Inc., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., announced the ...

Home September 26, 2022
Home
News | Hypertension

September 20, 2022 — Orchestra BioMed, Inc., a biomedical innovation company accelerating high-impact technologies to ...

Home September 20, 2022
Home
News | Hypertension

September 12, 2022 — Researchers at the National Institutes of Health have found that a novel blood test can be used to ...

Home September 12, 2022
Home
Subscribe Now