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Abbott scores regulatory wins in electrophysiology

February 2, 2023 By Danielle Kirsh

A close up photo of Abbott's TactiFlex ablation catheter. On a white background, there is a white handle with a long, black tube attached that runs across the middle of the image with and orange and silver end.
Abbott TactiFlex [Image courtesy of Abbott]
Abbott today announced two new regulatory approvals related to its TactiFlex and FlexAbility ablation catheters.

TactiFlex ablation catheter, sensor enabled (SE), received a CE mark for treating abnormal heart rhythms such as atrial fibrillation. The company’s FlexAbility ablation catheter, SE, also received an expanded indication from the FDA for treating patients with complex heart conditions.

The company’s TactiFlex ablation catheter SE has a unique flexible tip and contact force sensing. Its tip design has a laser-cut pattern that flexes when in contact with the heart wall to direct irrigation flow to the treated tissue and to increase catheter stability by up to two times for consistent therapy delivery.

Abbott said in a news release that the device has proven to reduce procedure times and patients’ exposure to radiation compared to standard power ablation. When integrated with the company’s EnSite X EP system, physicians can accurately identify areas in the heart that require ablation, deliver high-power, and more easily adapt to the heart tissue than conventional catheters.

TactiFlex is one of the latest devices in Abbott’s portfolio of electrophysiology devices designed to treat arrhythmias.

“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,” Dr. Isabel Deisenhofer, professor and head of the department of electrophysiology at the German Heart Center Munich in Germany, said in a news 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.”

Abbott’s FlexAbility ablation catheter SE is a flexible tip catheter that helps physicians identify abnormal signals and apply therapy to treat ventricular tachycardia in patients with non-ischemic cardiomyopathy.

In its LESS-VT study, Abbott said 80% of study patients were free from VT for at least six months post-procedure. The data also showed statistically significant improvements in patients’ mental and physical quality-of-life measures.

Filed Under: Catheters Tagged With: Abbott

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Tubing + Extrusion, Medical Design & Outsourcing and MassDevice. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.

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