SpectraWAVE Secures FDA Clearance for Intravascular Imaging Tech

Medical imaging company SpectraWAVE has received 510(k) clearance from the Food and Drug Administration (FDA) for its intravascular imaging system, HyperVue. The dual-modality system combines OCT and near-infrared spectroscopy (NIRS) to support physicians optimizing coronary stenting in the cardiac catheterization lab.

Additionally, SpectraWave announced, the system has now been used by multiple physicians as part of a first in-human study.

According to Eman Namati, CEO of SpectraWAVE, the company’s technology combines a no-flush catheter with an AI-powered user experience. With the DeepOCT-NIRS system, the physician controls both image acquisition and AI-enabled image review from the sterile field. The workflow is designed for simplicity when optimizing percutaneous coronary intervention.

Upon its receipt of regulatory clearance, Namati said, the company will begin the transition to a commercial entity and launch its product. In February 2021, SpectraWAVE earned $13.2 million in series A-2 financing to support completion of product development and regulatory filing for its flagship intracoronary imaging product.

According to Ziad Ali, director of the DeMatteis Cardiovascular Institute at St. Francis Hospital and Heart Center and director of the Angiographic Core Laboratory at the Cardiovascular Research Foundation in New York, who worked on the first in-human procedures, the system’s DeepOCT technology provides greatly improved visibility of critical structures such as the external elastic membrane and calcium, and the NIRS technology provides greater certainty in the classification of lipidic plaques.

“Clinical evidence strongly suggests that patients benefit from intravascular imaging-guided stent optimization,” Ali said. He believes that the HyperVue system will act as a tool leading to future applications in high-risk vulnerable plaque detection and treatment.

Initial cases from the first-in-human study (NCT05241665) have been conducted at the Department of Research Innovation, Angiografia de Occidente in Colombia, South America, under the guidance of Ali and fellow principal investigator Antonio Dager, interventional cardiologist and director of the Structural Heart Program.