Article source: Siyu MedTech; Editor: Yihe
Reprinting requirements: Reprinting can be done 24 hours after the first release, and the source must be indicated.
On August 22, 2022, Thermedical announced that the company had received FDA approval to conduct a clinical trial to evaluate The effectiveness of its SERF ablation system. Thermedical will then conduct an open-label, single-arm interventional clinical trial to evaluate the safety and efficacy of the Thermedical SERF thermal ablation system with Durablate catheter in the treatment of patients with ventricular tachycardia (VT) who are resistant to conventional treatments. effectiveness.
# 01 Thermedical’s SERF ablation system
Thermedical is a medical system developer headquartered in Massachusetts, USA, that mainly develops technology for soft tissue ablation. Thermedical technology can be used to treat ventricular tachycardia , as well as percutaneous puncture treatment of various types of cancer such as liver cancer, kidney cancer , lung cancer, etc. Its star product, the Saline Enhanced Radiofrequency (SERF) ablation system with Durablate catheter, provides a new biological heat transfer method that can be used to treat ventricular arrhythmias that are resistant to antiarrhythmic drugs or are resistant to standard ablation procedures. patient.
The current treatment for ventricular tachycardia (VT) can be an implantable cardioverter defibrillator (ICD). However, this method cannot stop the disease process or cure the disease, and ICD treatment is expensive and requires pain. Therefore, ablation technology is more used in the treatment of VT, among which radiofrequency ablation is the most commonly used ablation technology and is very successful in the treatment of atrial arrhythmia .
However, treating ventricular tachycardia often requires larger, deeper ablation zones within the thicker ventricular walls. Existing ablation catheters cannot reach the required depth. In order to solve the shortcomings of existing ablation technology, Thermedical has developed a new punctureable radiofrequency ablation technology - Thermedical Ablation.
▲Thermedical Ablation System (picture from official website)
Thermal Ablation’s heat transfer efficiency is 20 times that of traditional ablation methods. Compared with traditional VT ablation catheters, the Durablate catheter can precisely control the ablation area and treat tissue deep within the heart wall. Durablate uses an endocardial approach, with a 25G retractable electrode built into the distal end of the catheter. The electrode is porous and can penetrate the myocardium to treat from within the scar. Durablate not only releases radiofrequency power, but also injects saline into the myocardium. Saline can provide additional thermal energy to the treatment as well as convection to the biological heat transfer, thereby dispersing the energy in the tissue and creating transmural ablation in the ventricular wall. Today, patients with VT treated with an ICD can often receive routine radiofrequency ablation.
▲ (picture from the official website)
In May 2020, Thermedical’s SERF ablation system and Durablate catheter were awarded the breakthrough device designation by the FDA. The FDA Breakthrough Devices Program is designed to help patients gain more timely access to breakthrough technologies that may provide more effective treatments or diagnostics for life-threatening or irreversibly debilitating diseases.
# 02 Clinical trial at scale
Thermedical co-founder and CEO Michael Curley said in a press release: "We are grateful to the FDA for its prompt approval of this pivotal trial to evaluate our SERF ablation system for the treatment of VT. Effectiveness in patients with recurrent VT and very poor quality of life. In our recent multicenter trial , 31 of 32 participants had their clinical VT resolved immediately at the end of surgery, and in these patients during the subsequent 5 weeks. Treatments such as shock or pacing regulation reduced the risk by 89% at 3 months of follow-up."
It is reported that the Mayo Clinic will become the first clinical site among up to 25 research centers in North America to enroll a larger sample of patients for clinical trials, and American cardiac electrophysiologist Dr. Douglas Packer will become the principal investigator.In the future, the company will plan to add more sites in Birmingham, Alabama, Boston, Charleston and other places. The clinical trial will subsequently recruit 154 participants, who will undergo the SERF ablation procedure and undergo the SERF ablation procedure in 7 days, Follow-up visits were conducted after 1, 3, and 6 months.
Michael Curley also mentioned: "This larger clinical trial is very important for us to further evaluate innovative methods for this difficult-to-treat VT. If the trial is successful, it will help reduce the use of defibrillators for patients. Potential electric shock injuries will serve as a guide and will further verify the safety and effectiveness of SERF technology. In addition, SERF brings hope to people suffering from this disease because it may bring changes to the lives of VT patients. ".
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-