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Next-Generation IVUS Catheter Receives FDA Clearance
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The FDA has granted 510(k) clearance for a next-generation IVUS catheter that allows interventional cardiologists to examine coronary intravascular pathology in candidates for transluminal coronary interventional procedures.
The IVUS catheter (OptiCross, Boston Scientific) also received CE Mark and Japan Pharmaceutical Medical Devices Agency (PMDA) approval.
According to a press release, the IVUS catheter offers higher-resolution imaging than previous generation devices and may allow cardiologists to deliver IVUS catheters in complex cases.
The new product’s delivery system includes 5F guide catheter capability, a shorter and more tapered tip, a bi-segmented catheter shaft, and a catheter hub that was redesigned for better connection, according to the release.
Results from an ADAPT-DES substudy presented at TCT 2012 showed that IVUS-guided stent procedures were associated with better outcomes and fewer complications at 30 days and 12 months compared with procedures not guided by IVUS. Patients with IVUS-guided procedures also had a 50% reduction in stent thrombosis and 33% reduction in MI compared with patients who did not undergo IVUS-guided procedures.