SpectraWave’s HyperVue Intravascular Imaging System Cleared by FDA

March 1, 2023—SpectraWave, Inc. announced FDA 510(k) clearance of the company’s flagship HyperVue intravascular imaging system for the imaging of coronary arteries and indicated in patients who are candidates for transluminal interventional procedures.

According to the company, the system combines SpecraWave’s next-generation DeepOCT images and near-infrared spectroscopy (NIRS) with ease of use to support physicians optimizing coronary stenting in the cardiac catheterization lab.

The HyperVue system’s Starlight imaging catheter delivers rapid pullbacks of both imaging modalities in a single, low-profile, no-flush form factor. The NIRS capability of the system is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

The physician controls both image acquisition and artificial intelligence (AI)–enabled image review from the sterile field. This workflow is designed for simplicity for optimizing percutaneous coronary intervention (PCI) procedures, noted SpectraWave.

The company also advised that initial cases from the first-in-human study of the device have been conducted at the Department of Research Innovation, Angiografia de Occidente in Cali, Colombia, under the guidance of site Principal Investigator Antonio Dager, MD, and study Principal Investigator Ziad A. Ali, MD.

Dr. Dager is an interventional cardiologist and Director of the Structural Heart Program at Angiografia de Occidente.

Dr. Ali is Director of the DeMatteis Cardiovascular Institute at St. Francis Hospital and Heart Center in Roslyn, New York, and Director of the Angiographic Core Laboratory at the Cardiovascular Research Foundation in New York, New York.

“Clinical evidence strongly suggests that patients benefit from intravascular imaging-guided stent optimization,” commented Dr. Ali in the company’s press release. “After completing the first-in-human procedures, it’s clear SpectraWave has built something truly special with a combination of DeepOCT and NIRS, paired with a workflow and AI-enabled image analysis that will prove beneficial for precise and optimal coronary artery disease treatment.”

Dr. Ali continued, “The DeepOCT technology provides exceptional visualization of critical structures such as the external elastic membrane and calcium, while NIRS removes the guesswork in classifying lipidic plaques. I believe the HyperVue system will enable comprehensive and seamless PCI optimization, but also act as a trailblazing tool for future applications in high-risk vulnerable plaque detection and treatment.”