Marlborough, Mass.-based Boston Scientific’s DirectSense is available on the Rhythmia HDx mapping system that won FDA approval in April. Rhythmia HDx monitors changes in local impedance — electrical resistance — around the tip of the IntellaNav MiFi open-irrigated ablation catheter.
DirectSense offers data on the impedance around the catheter tip, measuring the ability of the tissue to respond to RF energy before physicians deliver therapy, according to a news release. It tracks local impedance change during ablation to help understand how the tissue is affected, leading to a reduction in the chances of over-ablation and complications.
Data from the Localize retrospective clinical trial showed 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). Dr. Ignacio Garcia-Bolao, director of cardiology & cardiovascular surgery at the University of Navarra (Pamplona, Spain) presented the data at Heart Rhythm Society 2020 Science.
Dr. David Callans, a professor of medicine at the Perelman School of Medicine at the University of Pennsylvania, the first center to use DirectSense in the U.S., said in a news release that the information the device provides physicians is unlike any existing product on the market.
“Building upon the success seen with the DirectSense technology in Europe, we are pleased to introduce this tool to physicians and their patients in the U.S.,” Boston Scientific rhythm management & global health policy senior VP & chief medical officer Dr. Kenneth Stein, M.D. said. “This approval marks an exciting milestone for our growing electrophysiology portfolio, providing physicians a more direct understanding of lesions and procedural efficiency to obtain optimal patient outcomes.”