DiamondTemp Ablation System FDA Approved for AFib
Cardiac ablation is the current go-to method for treating most cases of atrial fibrillation (AFib) that are not responsive to medications. While radiofrequency ablation, the most common kind, can be highly effective, the technique often results in damage to cardiac tissue beyond what is intended. This can be a result of poor heat dispersal, overly aggressive delivery of energy, or a number of other parameters such as poor targeting or lack of sensing of how hot things are getting.
Helping to overcome such matters, Medtronic has just received FDA approval to introduce its DiamondTemp ablation system in the United States. The ablation delivery catheter (8.5 Fr) for the new system features three diamonds near the tip, a material that has an exceptional ability to diffuse heat. This helps the built-in temperature sensor to get more accurate readings while reducing the amount of cooling irrigation fluid that needs to be pumped in, leading to faster procedures. As such, the DiamondTemp system can quickly and intelligently adjust energy delivery based on the sensed temperature of the tissue being ablated.
The catheter was designed to record high-resolution electrograms (EGM) that help physicians performing the procedure to identify treatment target locations as well as assess whether lesions are forming as expected.
Medtronic helped conduct a prospective, multicenter, single blind, non-inferiority, randomized, controlled trial to assess the safety and effectiveness of the DiamondTemp ablation system compared with a contact force-sensing ablation system. Here are some details about the study and its results:
The trial enrolled 482 patients (239 DTA, 243 control) across 23 sites in the United States, Europe and Canada. DIAMOND-AF is the largest completed AF ablation technology IDE trial which resulted in FDA approval to date.
Results demonstrated a freedom from patient complication rate of 96.7% in the DTA group versus 93.4% in the control (P<0.0001 versus -6.5% non-inferiority margin). Primary effectiveness for the treatment of AF was met in 79.1% of DTA and 75.7% of control subjects (P<0.0001 versus -12.5% non-inferiority margin).
Additionally, the DTA system demonstrated procedural advantages compared to the control group, with shorter total RF times and individual RF ablation duration, and reduction in volume of infused saline. A clinically meaningful quality-of-life improvement was also observed in both arms at 6 and 12-months post-ablation
“The DIAMOND-AF trial results are encouraging not only because the DTA system was shown to be safe and effective, but because the outcomes underscored significant procedural efficiencies for clinicians,” said JACC EP corresponding author Tom McElderry, M.D., University of Alabama, Birmingham, in a Medtronic announcement. “Improved efficiencies – including shorter total RF ablation times and individual RF ablation durations, are important for both the well-being of the patient and the productivity of the physician and lab staff.”
Product page: DiamondTemp Ablation System