The Pantheris SV System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 2.0 mm to 4.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies.

The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies.

The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies.

The Lightbox 3 imaging console is a line-extension of the Lightbox imaging consoles that have been used with catheters in the device families of the Ocelot CTO-crossing catheter system and the Pantheris atherectomy catheter system. The Lightbox 3 console is intended to be used in conjunction with compatible Avinger catheter products by means of an accessory Sled interface to facilitate spinning of fibers at the distal ends of catheters. The Lightbox 3 console houses a laser light source and transmits light to the intraluminal environment through an optical fiber in compatible Avinger products. The Lightbox 3 console receives and interprets the reflected light using a computer to analyze the reflected signal that is returned and processes it in order to present an OCT image of the vessel on the operator monitor in real time.

The Ocelot System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.

The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures.

Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a compatible Avinger product.

Imaging catheter accessories

Imaging catheter accessories

Imaging System

Imaging catheter consists of Novasight Hybrid Catheter, Accessory Pack and PIM Bag.

Imaging catheter

Imaging System

Imaging System

Software Upgrade Kit

Software Upgrade Kit

Imaging Software Upgrade Kit

2.0 Software Upgrade Kit

Software Upgrade Kit

Imaging System

Imaging System

Imaging System

Mobile Workstation

Installation Kit

Software Upgrade Kit

Software Upgrade Kit

Imaging System

Upgrade Kit

Tableside Controller

Installation Kit

Installation Kit

Software Upgrade

Software Upgrade

The diameter of the balloon is 16mm, the effective length is 30mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm

The diameter of the balloon is 16mm, the effective length is 55mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm

The diameter of the balloon is 16mm, the effective length is 80mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm

The diameter of the balloon is 18mm, the effective length is 30mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm

The diameter of the balloon is 18mm, the effective length is 55mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm

The diameter of the balloon is 18mm, the effective length is 80mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm

The diameter of the balloon is 20mm, the effective length is 30mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm

The diameter of the balloon is 20mm, the effective length is 55mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm

The diameter of the balloon is 20mm, the effective length is 80mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm

The machine model is C1, the light source sweep frequency is 100kHz

The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor.

The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor.

The OTIS 2.1 system includes a single-use specimen container, the Consumable Set, that facilitates tissue imaging. The consumable set consists of a Specimen Tray and Specimen Lid. The Specimen Tray engages with the device to initiate scanning and the Specimen Lid facilitates engaging vacuum to enable vacuum assisted specimen positioning during image acquisition.

The SpectraWAVE Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system. The SpectraWAVE Imaging System consists of the following components:• Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface. • Software: A proprietary application software that orchestrates the control, acquisition, processing, and display of the OCT-NIRS data. • Controller: A tethered controller that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console.• Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.

The SpectraWAVE Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system. The SpectraWAVE Imaging System consists of the following components:• Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface. • Software: A proprietary application software that orchestrates the control, acquisition, processing, and display of the OCT-NIRS data. • Catheter Interface Unit (CIU): A tethered CIU that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console.• Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.