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.

Garnering an expanded FDA clearance for pre- and post-percutaneous coronary intervention (PCI) assessments of coronary vessels, the Gentuity HF-OCT Imaging System led to procedural strategy changes for 80 percent of lesions and facilitated reduction of major adverse cardiovascular events (MACEs), according to recent research. (Image courtesy of Gentuity.)

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.