American and European regulatory agencies have recently given approval for clinical use of two systems—one a laser and one an optical coherence tomography (OCT) instrument—that target ophthalmology and cardiology, respectively.
The U.S. FDA has granted 510(k) clearance to Topcon Medical Laser Systems (Santa Clara, CA) to market its PASCAL Streamline 577 laser system, a solid-state, true-yellow 577 nm system with pattern-scanning capabilities for treating ophthalmic disorders such as diabetic retinopathy, wet age-related macular degeneration (AMD), glaucoma, and retinal vascular occlusive disease. According to Topcon president and CEO Hideharu Suzuki, the Streamline 577’s wavelength is “macula-friendly,” allowing surgeons to fine-tune laser output and minimize trauma to the retina.
Along similar lines, St. Jude Medical (St. Paul, MN) has received European CE Mark approval for its multimodal ILUMIEN system in diagnosing and treating coronary artery disease. ILUMIEN, which pairs OCT with fractional flow reserve (FFR), is the first instrument of its kind. St. Jude’s Medical PressureWire Aeris, a wireless interventional tool, measures FFR to evaluate the severity of blood flow blockages in the coronary arteries, and its C7-XR OCT diagnostic imaging technology with Extreme Resolution visualizes and measures vessel characteristics otherwise not visible or difficult to assess. The technologies enable optimization of percutaneous coronary intervention (PCI) by identifying culprit lesions responsible for ischemia (coronary narrowings that significantly obstruct blood flow to the heart) and by providing measurements of lesion dimensions and vessel size and structure.