International Cardio Corporation (ICC) announced this week that it has achieved the first human use of its high-intensity focused ultrasound system to designed to treat peripheral vascular disease (PVD).
The Minneapolis-based company said its HIFU Synthesizer system is undergoing a 15-patient safety study in the Netherlands.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 stabilizing 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,” said 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 Synthesizer.