US Medical Innovations’ ablation system gets FDA issues 510(k) clearance

The US Food and Drug Administration (FDA) has granted 510k clearance to US Medical Innovations for its Canady Helios Cold Plasma (CHCP) Ablation System, a novel technology intended for soft tissue ablation during surgeries.

The system comprises the Canady Helios Cold Plasma XL-1000 CP Smart Electrosurgical Generator, a foot pedal, Canady Helios Cold Plasma Ablators, and a trolley cart. It utilizes plasma to generate a plasma jet operating within a non-thermal temperature range of 24°C to 30°C.

During surgery, the plasma jet is applied intra-operatively for five to seven minutes, targeting the surgical margin of soft tissue post solid tumor removal. Its distinctive Plasma Treated Electromagnetic Field permeates cellular membranes, inducing apoptosis while preserving adjacent healthy tissue.

The CHCP system has demonstrated 'exceptional safety and efficacy profiles', achieving up to an 80% non-local recurrence rate and an overall survival rate of up to 86%.

US Medical Innovations intends to distribute the plasma system to hospitals later this year.