Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )
Infraredx, Inc.The Makoto Intravascular Imaging System™ is a medical imaging device that uses near-infrared spectroscopy combined with intravascular ultrasound to examine coronary and peripheral arteries. It helps clinicians detect lipid-core plaques, assess coronary artery lipid burden, and identify patients at risk of cardiac events by providing detailed images and compositional information of blood vessels. The device includes software that automatically identifies vessel borders and guide catheter locations, aiding in precise and efficient vascular assessment during invasive angiographic procedures.
Intended Use
The Makoto Intravascular Imaging System™ is intended for near-infrared examination of coronary arteries during invasive coronary angiography to detect lipid-core-containing plaques of interest, assess coronary artery lipid core burden, identify patients and plaques at increased risk of major adverse cardiac events, and for ultrasound examination of coronary and peripheral intravascular pathology.
Technology
The device combines near-infrared spectroscopy and intravascular ultrasound imaging in a dual-modality catheter system. It uses a swept source semiconductor laser for near-infrared light and a 50 MHz ultrasound transducer. The system offers image acquisition with preconfigured parameters including a penetration depth of approximately 8 mm, and operates in B-mode. It includes software features like Automatic Border Contouring that automatically delineates vessel lumen and EEM borders, and Guide Catheter Detection to automatically identify guide catheter edges during imaging.
Performance
The device was validated through bench testing of software features ABC and GCD demonstrating high accuracy and consistency with manual expert annotations. Performance metrics on test data show contouring errors within acceptable limits, and guide catheter detection achieved sensitivity of 0.86-0.93 and specificity of 1.00-0.93 for frame and scan level respectively. Testing included a diverse dataset from multiple clinical sites with annotated ground truth by expert IVUS readers, ensuring robust and unbiased evaluation. Sterilization and shelf life evaluations confirmed compatibility with predicate devices. No animal or clinical testing was performed in this submission.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/3/2024
8 months - 2
FDA Approval
2/26/2025
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