Avinger has received FDA approval for its Ocelot System, a multi-functional catheter for crossing chronic total occlusions (CTOs) in patients with Peripheral Artery Disease (PAD). It facilitates the intraluminal placement of conventional guidewires beyond stenotic lesions in the peripheral vasculature prior to further percutaneous intervention. The Ocelot integrates optical coherence tomography imaging (OCT), enabling physicians to see from inside an artery during the actual procedure, as an adjunct to conventional fluoroscopy images.
The Ocelot System is used in combination with the Lightbox, a mobile dual display imaging unit designed to deliver OCT images. The system can correlate media/lateral position on Lightbox with simultaneously acquired fluoroscopy images. Use of the system is contraindicated in iliac, coronary, cerebral, renal and carotid vasculature. FDA approval follows after Avinger’s CONNECT II global clinical trial, in which a total of 122 patients from both Europe and the U.S. took part. The Ocelot System demonstrated a CTO crossing success of 97 percent with a 98 percent freedom from Major Adverse Events (MAEs). The Ocelot received CE Mark in September of last year.
Features of the Ocelot according to Avinger:
CONSTANT OCT: When on, Ocelot images automatically.
RELATIVE POSITION: identify relative position to layered structures.
DIRECTIONALITY: Know how your catheter is oriented at all times.
SPIRAL WEDGES: Corkscrew through CtOs.
OCT IMAGING FIBER: 1.5 mm from distal tip.
PRE SHAPED TIP: increased directionality.
LOCAL FLUSH: Located right at the imaging fiber.
MANUAL FLUSH: Easily control the amount used.
1) OCt On/Off
2) Bi-Directional torque Knob
3) .014 Wire / Flush Lumen
MIDDLE MARkER: visable by OCt, is aligned with Ocelot’s radiopaque spine, visible by flouro.
DEFLECTION: Opposite Middle Marker.
OCELOT DISPLAY: Can be rotated to match angiogram
Flashback: Ocelot Catheter with OCT OK’ed in Europe
Press release: Avinger’s Ocelot System is FDA Cleared
Product page: Ocelot…