International Cardio Corporation (ICC) announced that it has achieved the first human use of its high-intensity focused ultrasound (HIFU) system to designed to treat peripheral vascular disease (PVD).
The Minneapolis-based company said its HIFU Synthesiser system is undergoing a 15-patient safety study in The Netherlands to investigate its feasibility and safety for the treatment of atherosclerotic plaques. The system uses high-intensity ultrasound to noninvasively treat vulnerable and occlusive plaques in peripheral arteries to reduce stroke mortality and improve the quality of life for those suffering from PVD.
“The potential for noninvasively ablating and stabilising vulnerable vascular plaques is a compelling opportunity to both reduce stroke risk and deliver better outcomes with higher patient safety than current treatment options for patients suffering from PVD,” says ICC chief operating officer David Lee in a news release.
The safety study is the first step toward achieving the CE mark and FDA approval HIFU Synthesiser.
On The Netherlands Trial Register website, the investigators summarise their study: “Current treatment of lower extremity peripheral arterial disease consists of risk factor modification, exercise therapy and pharmacological treatment initially, but intervention is frequently needed when patients are significantly disabled. Interventional treatment is invasive, either surgical or endovascular. This study investigates a new non-invasive technique that uses high intensity focused ultrasound to treat atherosclerotic arterial disease.”
The primary endpoint of the study is the 30-day major complication rate, which is a composite endpoint that includes 30-day major adverse limb event rate and 30-day mortality rate. Secondary outcomes assessed include a range of technical, MRI, echo-duplex, clinical, and quality of life parameters.