Leading Electrophysiologists (EPs) have performed several preclinical animal studies that support use of the Durablate for the successful treatment of VT.  

 

  • In vivo and ex vivo animal models demonstrate that SERF can make the large, transmural lesions required to treat the full extent of VT in the thick ventricle walls

  • Preclinical in vivo animal data include canine, ovine and porcine models.  

 

  • Investigators have concluded that the SERF Ablation Catheter can do the following:

 

  • Create larger lesions than existing therapeutic catheters in both infarcted and normal tissue

 

  • Create large, well-defined transmural ablations largely confined to the infarct scar 

 

  • Homogenize the infarct region and eliminate channels of viable myocardium in scar

 

  • Cure infarcted animals of VT inducibility

 

  • Deliver large lesions with no detectable additional effects on myocardial hemodynamic function and no evidence of myocardial perforation, wall thinning, or aneurysm formation in chronic animal studies

Durablate™ Ablation In Infarcted Porcine Tissue 
Durablate® ablation in infarcted porcine tissue

A list of posters and publications supporting these conclusions are available at this link and further information is available upon request.

 

The Thermedical® Ablation System is 510(k) cleared for the coagulation and ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.  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.

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