The Company has used its technology to investigate the treatment of VT and the treatment of soft tissue conditions in liver and kidney models. The Company has performed several preclinical animal studies that support the use of the Thermedical® Ablation System for the treatment of VT. Preclinical in vivo animal data include data from canine, ovine and porcine models.
The Company has a 510(k) clearance for use of the Thermedical® Ablation System for the coagulation and ablation of soft tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.
The use of the Thermedical Ablation System for any specific soft tissue indication has not been evaluated or approved by the US FDA.
Use of the Thermedical Ablation System for the treatment of VT is investigational and is not approved for use or sale in any market.