Device Dossier

REFINITY ST Rotational IVUS Catheter Model 89900 - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use

Device Dossier for REFINITY ST Rotational IVUS Catheter Model 89900 - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular,…

Intended purpose

Intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. Designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

Functional description

The REFINITY ST catheter consists of 2 assemblies: imaging core and catheter body. The catheter body is comprised of 4 sections: a distal section with a .014” guide wire lumen, a clear imaging window, a mid-shaft, a braided proximal shaft, and a telescoping section. The telescoping section is outside the catheter and allows the imaging core to be advanced and retracted for up to 15 cm of linear movement. The imaging core is composed of a hi-torque rotating cable with an ultrasonic transducer.

TGA Public Summary