Spryte’s Neuro OCT Imaging Gets Breakthrough Status

Spryte Medical has earned breakthrough device status from the U.S. Food and Drug Administration (FDA) for its neuro optical coherence tomography (nOCT) technology for neurointervention and cerebrovascular treatment.

Unlike traditional intravascular imaging designed mainly for cardiology, nOCT is engineered for cerebrovascular navigation. The imaging technology allows detailed visualization of the brain’s vascular anatomy at near histologic levels, according to Spryte. It can also offer improved diagnostic capabilities and treatment precision.

“Neurointervention has had an incredibly positive impact on the treatment of cerebrovascular conditions. nOCT intravascular imaging will allow us to advance the field even further,” commented Dr. Demetrius Lopes, a leading expert in neurointervention. “With this technology we will be able to better visualize disease and devices, guide our decision making and deliver even better patient care. I have followed the development of intravascular imaging in cardiology for many years. I always believed that OCT information could have an even greater impact in neurointervention outcomes and I am excited to bring the benefits of this technology into the brain for the first time ever. Spryte nOCT was developed specifically with neurointervention in mind and has the potential to overcome the many limitations that prevented its use in the neurovasculature previously. The initial nOCT clinical experience demonstrated consistently the ease of use, safety, and imaging quality. This is a dream coming true… our patients will benefit the most.”

nOCT is pointed to become the first, only intracranial imaging technology available that enables both intraluminal imaging as well as volumetric microscopy of the neurovascular vessels.

“Our engagement with the FDA through the Breakthrough Device and Total Product Life Cycle Advisory Program (TAP), highlights the potential of Spryte Medical’s neuro OCT imaging platform for patients with cerebrovascular disease,” added David Kolstad, CEO of Spryte Medical. “We look forward to working collaboratively with the FDA for the benefit of these patients.”