Boston Scientific’s Jetstream atherectomy system has received CE mark for a new in-stent restenosis indication. This indication gives EU physicians “another safe and effective treatment option for in-stent restenosis, a disease state that has historically been challenging to treat with traditional therapies,” says a Boston Scientific press release.
The indication is supported by data from the Jetstream-ISR feasibility study, in which the device demonstrated a strong safety profile, with zero device-stent interactions. The study included long, complex lesions (62% were TASC C&D). Six-month freedom from target lesion revascularisation was 86.2% with patency at 72%.