DualproTM IVUS+NIRS Imaging Catheter or Dualpro Catheter - Transducer assembly; ultrasound; diagnostic; intracorporeal; intravascular; single-use

Intended purpose

The DualproTM IVUS+NIRS Imaging Catheter is a single use, disposable coronary catheter designed for use with the Infraredx MakotoTM IVUS+NIRS Imaging System, TVC-MC10 and TVC-MC10i models. The Makoto IVUS+NIRS Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. The System is intended for the detection of lipid-core-containing plaques of interest and the assessment of coronary artery lipid core burden. The System is intended for identification of patients and plaques at increased risk of major adverse cardiac events. The System is intended for ultrasound examination of coronary intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Functional description

Dualpro Catheter has a tip, Tracking Reinforcement Sleeve, window, and shaft. Distal is coated with hydrophilic coating. Catheter outer body is made of a soft, atraumatic tip, a stiffer proximal shaft and a clear imaging window located to the TRS. The catheter is intended to be introduced into the vasculature via a coronary guidewire. With the catheter fixed handle held stationary by the Makoto Controller, the rotating hub can be advanced, retracted and rotated.