Biotronik begins new AlCath Flux eXtra Gold study

Biotronik has announced the commencement of a new clinical study of AlCath Flux eXtra Gold, its advanced irrigated ablation catheter with GoldTip technology.

The first enrolments have now been completed for the prospective multi-centre international Reduce-TE Pilot study, which will assess the ability of the catheter to reduce the incidence of silent microemboli (SME), a complication associated with catheter ablation therapy.

Biotronik's GoldTip technology and a 3D irrigation system are designed to diminish the number of SMEs via optimised cooling, thereby improving patient safety.

The Reduce-TE Pilot study will observe up to 125 patients, with the primary endpoint of the study being to investigate the incidence of new microembolic lesions occurring after treatment.

Wolf Ruhnke, vice-president at Biotronik, said: "We are now eager to explore what additional safety benefits the uniform cooling facilitated by our signature GoldTip and unique 3D irrigation system provides."

This comes after the firm last month completed a study of its Entovis pacemakers in patients undergoing full-body magnetic resonance imaging scans.