Boston Scientific has announced the US launch of DirectSense technology, a tool for monitoring the effect of radiofrequency (RF) energy delivery during cardiac ablation procedures. According to a press release, the DirectSense technology, which received US Food and Drug Administration (FDA) approval in April and is available on the Rhythmia HDx Mapping System, is the only tool to monitor changes in local impedance around the tip of the Intellanav MiFi open-irrigated ablation catheter, offering physicians an additional measurement of therapy effect during an ablation.
The company statement says that the DirectSense technology provides data on the impedance around the catheter tip to measure the ability of the tissue to respond to RF energy before physicians deliver therapy. During ablation, the tool tracks the change in local impedance which, in conjunction with other measures, offers physicians a distinct understanding of tissue characteristics and how they are affecting that tissue. These insights may indicate temperature change in the tissue, helping to reduce the chances of over-ablation and avoid complications.
Kenneth Stein, senior vice president and chief medical officer, rhythm management and global health policy, at Boston Scientific says in the press release: “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 US. 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.”
Boston Scientific says that it continues to expand its electrophysiology offerings with the recently granted CE mark for the POLARx Cryoablation System and plans to launch the product and begin enrolling European patients in a post-approval registry with the device in the coming months. It adds that the addition of this new single-shot therapy, alongside existing products and services, affirms the company’s commitment to providing meaningful advancements for the treatment of patients with atrial fibrillation.