Advancing a new approach to the treatment of ventricular tachycardia
A serious and growing problem
VT is often driven by abnormal electrical circuits located deep within scarred ventricular tissue, commonly following a heart attack or other structural heart disease.
There are an estimated 800,000 cases of sudden cardiac arrest annually in the United States and Europe, with the majority driven by VT or ventricular fibrillation.
Ventricular tachycardia (VT) is a complex condition with potentially fatal outcomes if not treated effectively.
Current therapies manage—but do not resolve—the disease
Standard treatment strategies include:
Implantable cardioverter defibrillators (ICDs)
Anti-arrhythmic medications
Radiofrequency ablation
These approaches can reduce episodes, but they:
Might not eliminate the underlying arrhythmia
Are associated with side effects
Contribute to long-term healthcare burden
Ablation remains limited in VT
Radiofrequency (RF) ablation is widely used and effective for atrial arrhythmias.
However, VT requires more controllable, larger and deeper lesions within the thick ventricular walls.
As a result:
Procedures are often long and complex
RF Lesions may not fully treat the substrate
There remains a need for a more effective approach.
Designed to treat the underlying substrate
Preclinical studies demonstrate that SERF technology can:
Create lesions of controllable and reproducible volumes in ventricular tissue
The dimensions of these lesions are reproducible to within 15%
These lesions can be large and/or transmural whenever needed, even when the tissue is scarred
Treat substrate within scarred myocardium
Deliver energy without causing steam pops
These characteristics are critical for addressing deep electrical circuits within the heart.
Preclinical data support VT treatment potential
Thermedical has conducted multiple in vivo studies across:
Canine
Ovine
Porcine models
These studies show that SERF can:
Create lesions that are significantly more controllable and reproducible than conventional catheters
Create larger lesions than conventional catheters when needed
Achieve consistent transmural ablation when needed
Eliminate channels of viable myocardium within scar
Eliminate VT inducibility in infarct models
Deliver therapy without perforation or structural damage
Deliver ablations with less embolic material (particles and bubbles)
Targeting substrate from within the myocardium
The Durablate® catheter is designed to treat VT using an endocardial approach exclusively. Epicardial access should never be needed.
Features include:
An extendable needle electrode that penetrates the myocardium when in place
Delivery of heated saline and RF energy simultaneously within the tissue to create nearly isothermal ablations without steam pops
The ability to create controllable lesions of any size that are full thickness (transmural) whenever needed
The ability to create lesions with reduced production of particulates and bubbles
This enables treatment of substrate from within the scar, rather than only from the surface.
A different path for VT treatment
By enabling deeper lesions which are nearly constant temperature, SERF has the potential to:
Improve patient outcomes
Improve treatment durability
Reduce recurrence
Shorten procedure time
Scientific foundation
Preclinical work has been presented at major scientific meetings, including the Heart Rhythm Society, and published in peer-reviewed journals.
Additional information is available upon request.
Regulatory status
The Thermedical Ablation System is 510(k) cleared for the coagulation and ablation of soft tissue.
Use of the system for the treatment of ventricular tachycardia is investigational and has not been approved for use or sale in any market.