Makoto Intravascular Imaging System™

Primary DI

00857595006432

Basic UDI-DI Code

B-00857595006432

Reference

TVC-MC10

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Infraredx, Inc.

The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravascular imaging system that enables structural assessment of coronary and peripheral arteries and plaques by using integrated Extended Bandwidth IVUS imaging and chemical assessment of coronary arteries and plaques using NIRS (near infrared spectroscopy) to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50 MHz Extended Bandwidth rotational IVUS imaging from a single catheter. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) and the Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit (TVC-E195-42). Indications for Use: 1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events. 2. The System is intended for ultrasound examination of coronary and peripheral intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary and peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).