FDA clears Gentuity imaging system for coronary interventions

Gentuity announced today that it received FDA 510(k) clearance for its HF-OCT imaging system with the Vis-Rx micro-imaging catheter.

Sudbury, Massachusetts-based Gentuity received approval for the technology for use both before and after percutaneous coronary intervention (PCI). The company said this makes it the only intravascular imaging platform specifically indicated for the assessment of the coronary vessel pre- and post-intervention.

According to a news release, recent studies showed that pre-PCI imaging with OCT led to changes in procedural strategy of 80% of lesions. That includes lesion assessment (45%), vessel preparation strategy (27%), stent diameter (37%) and stent length (36%).

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