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Boston Sci’s DIRECTSENSE Ablation Monitoring Tech Coming to U.S.


Boston Scientific is releasing in the United States its DIRECTSENSE Technology for live monitoring of cardiac tissue during radiofrequency ablation procedures. The capability is designed for use on the company’s RHYTHMIA HDx Mapping System along with the INTELLANAV MiFi Open-Irrigated ablation catheter and it works by measuring the change in electrical impedance of the tissue around the catheter as it is being irradiated.

It is currently very difficult to create sufficient lesions that alleviate cardiac arrhythmias while also minimizing unnecessary damage to surrounding tissues. Physicians have to perform a good deal of estimation based on patient anatomy combined with previously acquired knowledge and experience in similar procedures. As such, too often there’s insufficient ablation or overablation, which either don’t resolve the cause of an arrhythmia or cause additional side effects.

“Knowing the change in impedance around the tip of the catheter provides unique information about local tissue characteristics and the development of the lesion,” said David J. Callans, M.D., professor of medicine at the Perelman School of Medicine, University of Pennsylvania, in a Boston Scientific announcement. “Unlike existing products on the market, the DIRECTSENSE Technology assists physicians in evaluating pre-ablation tissue health, while supporting better clinical understanding of how they are influencing that tissue to guide minimal, predictable ablation during a procedure.”

Some related study data from the announcement:

According to chronic data from the LOCALIZE clinical trial, a retrospective analysis of the DIRECTSENSE Technology presented by Ignacio Garcia-Bolao, M.D., director of cardiology and cardiovascular surgery, University of Navarra, Pamplona, Spain at Heart Rhythm Society 2020 Science, a local impedance decrease of ≥16.6 ohms with an inter-lesion spacing of ≤ 6mm showed a ≥ 98% positive predicative value of durable pulmonary vein block at three months in patients with paroxysmal atrial fibrillation (AF).

Product page: DIRECTSENSE Technology

Via: Boston Scientific



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