Starlight Imaging Catheter
SpectraWAVE, Inc.The Starlight Imaging Catheter is a sterile, single-use catheter designed for imaging coronary arteries in patients undergoing transluminal interventional procedures. It uses near-infrared light and an internal rotating fiber optic core to capture detailed cross-sectional images inside vessels, helping clinicians assess vessel condition and guide interventions safely and effectively.
Intended Use
Starlight Imaging Catheter with HyperVue Imaging System is intended for imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. Intended for use in vessels 2.0 to 5.2 mm in diameter; not for use in vessels with previous bypass.
Technology
The device consists of a catheter body and an internal rotating fiber optic imaging core that delivers near infrared light to the vessel tissue and collects reflections while moving longitudinally and rotating inside the vessel sheath. It connects to the HyperVue Imaging System for data acquisition and imaging.
Performance
Performance testing included confirmatory bench testing for optical performance, catheter deliverability, pullback performance, trackability, kink resistance, tensile strength, biocompatibility tests per ISO 10993-1, and animal testing in porcine models confirming safety and performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/27/2024
5 months - 2
FDA Approval
3/20/2025
Other devices from SpectraWAVE, Inc.
- HyperVue™ Software2025 • 510K
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