Abbott announces expanded FDA indication, CE Mark for two ablation catheters
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Abbott today announced the FDA approval and receipt of CE Mark for two of its sensor-enabled ablation catheters.
The FDA approved an expanded indication of its sensor-enabled, flexible tip catheter (FlexAbility Ablation Catheter, Sensor Enabled) to treat ventricular tachycardia in patients with non-ischemic cardiomyopathy, according to a company press release.
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The approval was based on the results of the LESS-VT study of the safety and effectiveness of ablation for the treatment of ventricular tachycardia in patients with non-ischemic cardiomyopathy. Following ablation with the sensor-enabled catheter, 80% of the study cohort were free from ventricular tachycardia for at least 6 months and showed significant improvements in measures of both mental and physical quality of life.
The company also announced that its ablation catheter designed with a flexible tip and contact force sensing (TactiFlex Ablation Catheter, Sensor Enabled) had received CE Mark in Europe.
The catheter can be integrated with the company’s ablation system (EnSite X EP) to allow physicians to identify areas for ablation treatment, according to the release.
The next-generation catheter can also reduce procedure times compared with the company’s previous-generation catheters, according to the release.
The approval was based on the results of the TactiFlex AF IDE study of treatment using high-power ablation (40-50 Watts) in which the catheter created fast, safe lesions to treat the arrhythmia with more than 99% acute procedural success, according to the release.
"When we treat complex ablation cases for people battling arrhythmias, we want to eliminate the arrhythmia and get our patients back to living their lives," Isabel Deisenhofer, MD, professor and head of the department of electrophysiology at the German Heart Centre Munich in Germany, said in the release. "The TactiFlex catheter’s data around using high-power during ablation will be game-changing for patients. When you combine these tools with Abbott’s EnSite X EP System, the innovation is truly opening new doors in patient care."
The catheter is currently undergoing FDA review for premarket approval.
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