Thermedical Archives - Medical Design Sourcing

Thermedical completes feasibility study to use SERF with PFA

[Image from Thermedical]Thermedical announced today that it completed a feasibility study using pulsed field ablation in combination with its SERF ablation system.

Weston, Massachusetts–based Thermedical designed its SERF system and Durablate catheter to work with PFA to treat ventricular tachycardia (VT).

According to Thermedical, SERF (saline-enhanced radio frequency) ablation provides a new, more efficient form of biological heat transfer than conventional RF ablation methods. The company says its Durablate catheter delivers energy with a high level of accuracy. It treats tissue deeper in the heart wall, where arrhythmias causing VT often appear.

Thermedical is evaluating SERF with Durablate as a treatment for arrhythmias resistant to antiarryhtmic drugs or standard ablation. It believes that adding PFA to SERF ablation could offer a more complete approach to VT ablation.

“We are encouraged by the results from our pre-clinical feasibility study ev…

Thermedical wins FDA nod for clinical trial of ablation tech

[Image from Thermedical]Thermedical announced today that it received FDA approval for a clinical trial to evaluate its SERF ablation system.

Waltham, Massachusetts-based Thermedical will conduct an open-label, single-arm interventional clinical trial to evaluate the safety and efficacy of the Thermedical SERF ablation system with the Durablate catheter in people with ventricular tachycardia (VT) resistant to conventional treatment.

Thermedical designed the SERF ablation system with the Durablate catheter to treat patients with ventricular arrhythmias resistant to antiarrhythmic drugs or standard ablation procedures. The current treatment for VT comes in the form of implantable cardiac defibrillators (ICDs). VT patients with ICDs who experience VT episodes may be treated with conventional radiofrequency ablation.

According to a news release, the system provides a new form of biological heat transfer that it designed to be more efficient than conventional abl…

New method of cardiac ablation used in first in-human trial for ventricular tachycardia

Thermedical’s Durablate catheter [Photo courtesy of Thermedical]

A new cardiac ablation technique for patients with ventricular tachycardia (VT) has been used in its first in-human multicenter trial involving Mayo Clinic.

The new process — needle ablation using in-catheter, heated, saline-enhanced, radio frequency (SERF) energy — creates lesion scars inside the heart muscle where life-threatening arrhythmias cause VT, Mayo Clinic said. Injecting heated saline at the same time as the RF energy is applied increases heat transfer compared to conventional methods of ablation, which means the ablation can treat tissue deeper in the heart wall than the surface.

Caused by irregular electrical signals in the lower chambers of the heart, VT can trigger heartbeats so rapid that the heart’s chambers don’t fill with blood properly. VT can also stop the heart entirely. Implantable cardioverter-defib…