FDA Grants Expanded Clearance of Intravascular Imaging System for Use with Percutaneous Coronary Interventions

The Food and Drug Administration (FDA) has expanded the 510(k) clearance of the Gentuity HF-OCT Imaging System to include an indication for evaluation of coronary vessels before and after percutaneous coronary intervention (PCI) procedures.¹

Gentuity, the manufacturer of the Gentuity HF-OCT Imaging System, said the platform’s 1.8 F Vis-Rx Micro-Imaging Catheter offers a low crossing profile that makes it uniquely suited for pre-PCI assessments.

Recent research has demonstrated that use of the Gentuity HF-OCT Imaging System for pre-PCI evaluation led to procedural strategy changes for 80 percent of lesions, including changes with stent diameter and length. Other studies have shown a reduction of major adverse cardiovascular events (MACEs) with the pre-PCI use of the system, according to Gentuity.^2,3

Hiram Bezerra, M.D., called the expanded FDA clearance for the Gentuity HF-OCT Imaging System “a major step forward” for coronary interventions.

“The ability to assess coronary arteries comprehensively before and after intervention enhances procedural planning and post-procedural assessment, ultimately improving patient outcomes. The high-speed pullback, 100 mm in 1 second, coupled with a very small catheter profile, 1.8 F, position HF-OCT as the ideal system for pre-intervention imaging,” noted Dr. Bezerra, the medical director of the TGH Interventional Cardiology Center of Excellence at Tampa General Hospital.

References

1. Gentuity. Gentuity HF-OCT Imaging System receives FDA 510(k) clearance for pre- and post-coronary intervention imaging. PR Newswire. Available at: https://www.prnewswire.com/news-releases/gentuity-hf-oct-imaging-system-receives-fda-510k-clearance-for-pre--and-post-coronary-intervention-imaging-302282402.html . Published October 22, 2024. Accessed October 23, 2024.

2. Bergmark B, Dallan LAP, Pereira GTR, et al. Decision-making during percutaneous coronary intervention guided by optical coherence tomography: insights from the LightLab initiative. Circ Cardiovasc Interv. 2022;15(11):872-881.

3. Holm NR, Andreasen LN, Neghabat O, et al. OCT or angiography guidance for PCI in complex bifurcation lesions. N Engl J Med. 2023;389(16):1477-1487.