Thermedical said today that it won an investigational device exemption from the FDA for a clinical trial of its Durablate catheter for treating ventricular tachycardia.
The Durablate catheter is designed to simultaneously inject hot saline and use radiofrequency energy to effect the ablation; the Thermedical claims that the method is 20 times more effective than conventional RF ablation.
The Waltham, Mass.-based company said the 30-patient early feasibility study is designed for patients already implanted with an implantable cardioverter defibrillator who’ve also had a conventional VT ablation procedure that failed. The trial’s primary completion date is January 2019, with a final completion date in July 2019, according to ClinicalTrials.gov.
The primary safety outcomes are device-related adverse events at 30 days, major adverse cardiac events after two days and non-inducibility of clinical VT and/or elimination of clinically relevant scar or channels. The efficacy outcomes are intraprocedural non-inducibility and/or scar homogenization of target VT and elimination of the target VT and/or reduction in number of VT episodes at six months.
“Receiving IDE approval to begin clinical testing of our innovative ablation therapy in patients is an important next step to advance treatment to reduce or potentially eliminate VT episodes,” co-founder & CEO Michael Curley said in prepared remarks. “There is significant need for an effective ablation therapy that can serve as an adjunct to, or as a possible replacement for ICDs. We believe our solution may be a low-cost alternative for treating VT and it might save the US healthcare system significant costs associated with VT treatment today.”