Tool to assess treatment effect during cardiac ablation launches in US
Boston Scientific announced the launch of a monitoring tool to assess effects of radiofrequency energy delivery during cardiac ablation procedures.
The monitoring tool (Directsense), which is used with a mapping system (Rhythmia HDx), tracks changes in local impedance around the open-irrigated ablation catheter (Intellanav MiFi), according to a press release from the company. This provides physicians with information on potential treatment effect before radiofrequency energy is delivered, in addition to information on tissue characteristics such as temperature changes to avoid complications and over-ablation.
“Knowing the change in impedance around the tip of the catheter provides unique information about local tissue characteristics and the development of the lesion,” David J. Callans, MD, professor of medicine at the University of Pennsylvania Perelman School of Medicine, said in the release. “Unlike existing products on the market, the Directsense technology assists physicians in evaluating pre-ablation tissue health while supporting a better clinical understanding of how they are influencing that tissue to guide minimal, predictable ablation during a procedure.”
Findings from a retrospective analysis of this technology — the LOCALIZE trial — determined that a local impedance decrease of 16.6 ohm or greater with an interlesion spacing of less than 6 mm in patients with paroxysmal atrial fibrillation contributed to a positive predictive value of at least 98% for durable pulmonary vein block at 3 months.
“This approval is an exciting milestone for our growing electrophysiology portfolio, providing physicians a more direct understanding of lesions and procedural efficiency to obtain optimal patient outcomes,” Kenneth Stein, MD, senior vice president and chief medical officer of rhythm management and global health policy for Boston Scientific, said in the release.