Gentuity® HF-OCT Imaging System Receives FDA 510(k) Clearance for Pre- and Post-Coronary Intervention Imaging

Intravascular Imaging Technology Featuring the World’s Smallest Imaging Catheter Now FDA Cleared for Pre- and Post-Intervention Use.

SUDBURY, Mass., Oct. 22, 2024 /PRNewswire/ — Gentuity, LLC, a global leader in advanced intravascular imaging technologies, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Gentuity HF-OCT Imaging System, featuring the Vis-Rx Micro-Imaging Catheter, for use both before and after percutaneous coronary intervention (PCI), making it the only intravascular imaging platform specifically indicated for the assessment of the coronary vessel pre and post intervention.

Intravascular imaging has long been recognized for its ability to improve patient outcomes during PCI. Recent studies, such as the LightLab initiative, have shown that pre-PCI imaging with OCT led to changes in procedural strategy in 80% of lesions, including lesion assessment (45%), vessel preparation strategy (27%), stent diameter (37%), and stent length (36%).¹

Building on these insights, Gentuity has developed and commercialized the Vis-Rx Micro-Imaging Catheter, which at 1.8 F is the world’s smallest imaging platform. The low crossing profile of the Vis-Rx Micro-Imaging Catheter makes it uniquely capable of performing essential pre-PCI imaging, reducing the need for pre-dilation, streamlining the procedural workflow, and enhancing intervention accuracy by allowing clinicians to assess coronary arteries in their native state.

“We are excited to receive this FDA clearance, which marks a major milestone for the Gentuity HF-OCT Imaging System,” said Desmond Adler, President of Gentuity, LLC. “The ability to image pre-PCI where it is most needed—without pre-dilation—offers clinicians unparalleled opportunities to optimize treatment plans and obtain previously unavailable insights throughout the entire procedure. Combined with our AI-guided analysis tools, best-in-class scan range for left main and bifurcation assessment, and seamless device setup, the Gentuity HF-OCT Imaging System is truly an indispensable tool for advancing patient care.”

Dr. Hiram Bezerra, Medical Director of TGH Interventional Cardiology Center of Excellence at Tampa General Hospital, emphasized the significance of this advancement: “The expanded indication for the Gentuity HF-OCT Imaging System, particularly for pre-PCI imaging, represents a major step forward in coronary intervention. 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.”

Key Benefits of the Gentuity HF-OCT Imaging System:

Smallest Imaging Catheter: The 1.8 F Vis-Rx Micro-Imaging Catheter is the smallest intravascular imaging device in the world, designed with a low crossing profile to streamline image acquisition without the potential need for pre-dilation.
Pre- and Post-Intervention Use: Designed to streamline workflow and enhance decision-making in PCI procedures, the Vis-Rx Imaging catheter, integrated with advanced AI-driven software, enables physicians to access real-time, actionable insights in as little as one second. The innovative system improves procedural efficiency while also minimizing contrast utilization.²
Improved Clinical Outcomes: Pre-PCI imaging with OCT has been shown to enhance procedural planning, reduce MACE, and improve stent deployment.^3,4

For more information about the Gentuity HF-OCT Imaging System and its expanded indications, please visit Gentuity’s website or contact Gentuity’s global distribution partner Nipro Corporation.

The Gentuity HF-OCT Imaging System will be featured during an industry sponsored symposium at the upcoming TCT (Transcatheter Therapeutics) Conference in Washington D.C. on Monday October 28^th . Visit the Nipro booth (#3005) during the conference to learn more.

About Gentuity, LLC

Based in Sudbury, MA, Gentuity is a commercial-stage medical technology company with a global presence focused on developing next-generation intravascular imaging devices using best-in-class technologies. The company’s mission is to advance patient care, improve outcomes, and expand the utility of intravascular procedural guidance tools in cardiovascular disease.

¹Bergmark, B. et al: Decision-Making During Percutaneous Coronary Intervention Guided by Optical Coherence Tomography: Insights From the LightLab Initiative. Circ Cardiovasc Interv. 2022;15:e011851. DOI: 10.1161/CIRCINTERVENTIONS.122.011851.

² Uemura, Shiro, et al. “Abstract 11731: Efficacy of a new generation fast-pullback, high-frequency intracoronary optical coherence tomography imaging on the reduction of contrast medium in clinical practice.” Circulation, vol. 148, no. Suppl_1, 7 Nov. 2023, https://doi.org/10.1161/circ.148.suppl_1.11731.

³ Holm, Niels R., et al. “OCT or angiography guidance for PCI in complex bifurcation lesions.” New England Journal of Medicine, vol. 389, no. 16, 19 Oct. 2023, pp. 1477–1487, https://doi.org/10.1056/nejmoa2307770.

⁴ Hong, Sung-Jin, et al. “Optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention for patients with complex lesions (OCCUPI): An investigator-initiated, multicentre, randomised, open-label, Superiority Trial in South Korea.” The Lancet, vol. 404, no. 10457, Sept. 2024, pp. 1029–1039, https://doi.org/10.1016/s0140-6736(24)01454-5.

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SOURCE Gentuity, LLC