US-based medical equipment manufacturer SpectraWAVE has received the US Food and Drug Administration (FDA) 510(k) approval for its HyperVue intravascular imaging system.

HyperVue is intended for the imaging of coronary arteries and is indicated for patients who are eligible for transluminal interventional procedures.

The system combines next-generation DeepOCT images and near-infrared spectroscopy (NIRS) to optimise coronary stenting in the cardiac catheterisation lab.

SpectraWAVE said that its HyperVue intravascular imaging system has already been used by several physicians as part of a first-in-human study.

The first-in-human study was conducted at the Department of Research Innovation, Angiografia de Occidente in Colombia, South America.

SpectraWAVE chief executive officer Eman Namati said: “This is a landmark day for SpectraWAVE, but more importantly, a critical step towards improving outcomes for patients with coronary artery disease.

“Our proprietary DeepOCT-NIRS imaging system pushes the technological limits of optical coherence tomography—both in image quality and depth—while combining it with spectroscopy for the first time, packaging both into a no-flush catheter with an artificial intelligence-powered user experience.

“With this regulatory clearance, we are excited to begin the transition to a commercial entity and launch our product.”

According to the company, intravascular imaging has become an essential tool to optimise around one million coronary stenting procedures per year in the US.

It provides insights into plaque morphology, plaque modification decisions, stent and balloon sizing, landing zone selection, treatment optimisation and risk of adverse events in future.

HyperVue is the first intravascular imaging system to combine DeepOCT and NIRS imaging technologies, in addition to optimising image quality and procedural efficiency in the cath lab.

Its Starlight imaging catheter delivers rapid pullbacks of both imaging modalities in a single, low-profile, no-flush form factor.

Also, it allows physicians to control both image acquisition and AI-enabled image review, for optimising percutaneous coronary intervention (PCI), said the company.

Established in 2017, SpectraWAVE is a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD).