Gentuity HF-OCT System FDA Cleared for Pre- and Post-PCI Imaging

October 22, 2024—Gentuity, LLC, a developer of intravascular imaging technologies, announced FDA 510(k) clearance for the Gentuity HF-OCT imaging system for assessment of the coronary vessel both before and after percutaneous coronary intervention (PCI). The platform features the company’s 1.8-F Vis-Rx microimaging catheter.

According to the company, the low crossing profile of the Vis-Rx catheter makes it capable of performing essential pre-PCI imaging, reducing the need for predilation, streamlining the procedural workflow, and enhancing intervention accuracy by allowing clinicians to assess coronary arteries in their native state while also minimizing contrast use. In addition, pre-PCI imaging with OCT has been shown to reduce major adverse cardiac events and improve stent deployment, noted the Gentuity press release.

Hiram Bezerra, MD, Medical Director of TGH Interventional Cardiology Center of Excellence at Tampa General Hospital in Tampa, Florida, commented on the FDA clearance in the company’s press release.

“The expanded indication for the Gentuity HF-OCT imaging system, particularly for pre-PCI imaging, represents a major step forward in coronary intervention,” stated Dr. Bezerra. “The ability to assess coronary arteries comprehensively before and after intervention enhances procedural planning and postprocedural 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 preintervention imaging.”

Gentuity’s global distribution partner is Nipro Corporation. The Gentuity HF-OCT imaging system will be presented at Nipro’s booth and featured during an industry-sponsored symposium on October 28 at TCT 2024, the Transcatheter Cardiovascular Therapeutics conference held October 27-30 in Washington, DC, advised the company.