SpectraWAVE has announced US Food and Drug Administration (FDA) 510(k) clearance for product enhancements to the HyperVue imaging system, an intravascular imaging system combining next-generation DeepOCT images and near infrared spectroscopy (NIRS) to support physicians optimising coronary stenting in the cardiac catheterisation lab.
Updates include contrast-free saline imaging, artificial intelligence (AI) algorithms to support the identification of key clinical structures of calcium and external elastic lamina (EEL), and hands-free angiographic co-registration. The latest clearance adds to the existing HyperVue toolkit, which includes AI-enabled lipid, lumen, stent, and side branch detection, as well as the no-flush prep Starlight imaging catheter designed for efficient setup and image acquisition in complex lesions.
“Intravascular imaging is essential to optimise patient outcomes,“ said Richard A Shlofmitz (St Francis Hospital and Heart Center, Roslyn, USA). “I use intravascular imaging in all my coronary stenting patients, and I am delighted to see SpectraWAVE enter the arena and push the limits of these technologies to help us better care for our patients. The combination of DeepOCT and NIRS is ground-breaking and provides important clinical information that was previously unavailable. With the recent updates that allow for contrast-free saline imaging and support image review with artificial intelligence, this product will provide significant value to both experienced physicians and those just beginning to embrace imaging.”
“HyperVue had already set a new bar for intravascular imaging, and these additions now solidify its place as a leapfrog platform in the catheterisation lab,” said Eman Namati, chief executive officer of SpectraWAVE. “Optimal stenting outcomes for patients, as demonstrated by the wealth of randomised clinical studies and meta-analyses, are predicated on the ability to acquire high-quality intravascular images and distil the data into clinical actions. We have pushed the limits of image quality with our DeepOCT-NIRS technology, created a simple low-profile no-flush prep catheter, and enabled long and fast pullbacks.
“We have now expanded our AI algorithms to support EEL-based vessel measurements, fully automated angiographic co-registration to map findings back to the angiogram, and enable saline imaging to mitigate the need for additional contrast use. The team is thrilled about these new additions and their ability to have a meaningful and broad impact on patient care. This next-generation intravascular imaging product serves as the backbone of the HyperVue platform as a diagnostic hub for interventionalists, with the addition of a fractional flow reserve physiology assessment on its way.”
