Home/Specialty/Cardiovascular/Catheter, Intravascular, Plaque Morphology Evaluation/Dualpro™ IVUS+NIRS Imaging Catheter Kit

Infraredx, Inc. TVC-C195-42 Dualpro™ IVUS+NIRS Imaging Catheter Kit

Company Name

Infraredx, Inc.

Catalog Number

TVC-C195-42

Description

The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) is a single use, disposable coronary catheter and accessory kit designed for use only with the Makoto Intravascular Imaging System™ (TVC-MC10 and TVC-MC10i). The dual-modality intravascular imaging catheter combines 50 MHz Extended Bandwidth IVUS transducer and laser-based near infrared spectroscopy (NIRS) for simultaneous acquisition of vessel structure and plaque composition data— a single catheter, a single pullback, two sets of data. The Dualpro™ IVUS+NIRS Imaging Catheter features a durable hydrophilic coating for improved deliverability.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. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

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Additional Details

Device Identifier

00857595006234

Is RX

Yes

Is Over the Counter

No

Requires Sterilization

No

Is Sterile

Yes

Is Single Use

Yes

Categories

Barcode Mapping

Unit of Measurement	Eaches	GTIN
Each	1	00857595006234
Carton of 5	5	00857595006333