The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the
The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if desired. Its use is explained in the IFU.
The SoundBite® Console generates controlled high-amplitude short-duration mechan
The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i.e., shock waves) which are transmitted to a connected SoundBite® Active Wire 14P and cause the distal tip of the active wire to move back and forth (axially), acting like a micro-jackhammer. After the passage of each pulse, the tip goes back to its original position.
The SoundBite® Active Wire 14P which is part of the SoundBite® Crossing System
The SoundBite® Active Wire 14P which is part of the SoundBite® Crossing System - Peripheral (14P) is supplied sterile, has a maximum outer diameter of 0.014” in its usable length (145 cm) and is 300 cm long. Only the distal 145 cm of the SoundBite® Active Wire 14P is ever in contact with patient vasculature. At the proximal end of the SoundBite® Active Wire 14P, a section reducer allows the wire to be connected to the SoundBite® Console.
The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the
The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if desired. Its use is explained in the IFU.
The SoundBite® Console generates controlled high-amplitude short-duration mechan
The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i.e., shock waves) which are transmitted to a connected SoundBite® Active Wire 14P and cause the distal tip of the active wire to move back and forth (axially), acting like a micro-jackhammer. After the passage of each pulse, the tip goes back to its original position.
The SoundBite® Active Wire 14P which is part of the SoundBite® Crossing System
The SoundBite® Active Wire 14P which is part of the SoundBite® Crossing System - Peripheral (14P) is supplied sterile, has a maximum outer diameter of 0.014” in its usable length (145 cm) and is 300 cm long. Only the distal 145 cm of the SoundBite® Active Wire 14P is ever in contact with patient vasculature. At the proximal end of the SoundBite® Active Wire 14P, a section reducer allows the wire to be connected to the SoundBite® Console.
The Upstream™ GoBack (GB) Crossing Catheter is designed to address the needs of
The Upstream™ GoBack (GB) Crossing Catheter is designed to address the needs of vascular interventionalists (Radiologists, Angiologists) and vascular surgeons when attempting to place a guidewire in the peripheral vasculature during endovascular procedures.The Upstream™ GB Crossing Catheter is intended to be used in conjunction with a steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires.The Upstream GoBack Crossing Catheter have outer diameter of 4FRr (1.4mm) or 2.9Fr (0.96mm), accommodate 0.018” or 0.014” guidewires accordingly, and both diameters have effective length of 80cm or 120 cm.
The Upstream™ GoBack (GB) Crossing Catheter is designed to address the needs of
The Upstream™ GoBack (GB) Crossing Catheter is designed to address the needs of vascular interventionalists (Radiologists, Angiologists) and vascular surgeons when attempting to place a guidewire in the peripheral vasculature during endovascular procedures.The Upstream™ GB Crossing Catheter is intended to be used in conjunction with a steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires.The Upstream GoBack Crossing Catheter have outer diameter of 4FRr (1.4mm) or 2.9Fr (0.96mm), accommodate 0.018” or 0.014” guidewires accordingly, and both diameters have effective length of 80cm or 120 cm.
The Upstream™ GoBack (GB) Crossing Catheter is designed to address the needs of
The Upstream™ GoBack (GB) Crossing Catheter is designed to address the needs of vascular interventionalists (Radiologists, Angiologists) and vascular surgeons when attempting to place a guidewire in the peripheral vasculature during endovascular procedures.The Upstream™ GB Crossing Catheter is intended to be used in conjunction with a steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires.The Upstream GoBack Crossing Catheter have outer diameter of 4FRr (1.4mm) or 2.9Fr (0.96mm), accommodate 0.018” or 0.014” guidewires accordingly, and both diameters have effective length of 80cm or 120 cm.
The Upstream™ GoBack (GB) Crossing Catheter is designed to address the needs of
The Upstream™ GoBack (GB) Crossing Catheter is designed to address the needs of vascular interventionalists (Radiologists, Angiologists) and vascular surgeons when attempting to place a guidewire in the peripheral vasculature during endovascular procedures.The Upstream™ GB Crossing Catheter is intended to be used in conjunction with a steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires.The Upstream GoBack Crossing Catheter have outer diameter of 4FRr (1.4mm) or 2.9Fr (0.96mm), accommodate 0.018” or 0.014” guidewires accordingly, and both diameters have effective length of 80cm or 120 cm.
The Ocelot System is intended to facilitate the intraluminal placement of conven
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 Ocelot PIXL System consists of the Ocelot PIXL Catheter (“Ocelot PIXL”), th
"The Ocelot PIXL System consists of the Ocelot PIXL Catheter (“Ocelot PIXL”), the Lightbox console (“Lightbox”), and the Lightbox Umbilical (“Umbilical”). This system combines the use of Avinger’s peripheral catheter designs and an Optical Coherence Tomography (OCT) intravascular orientation and imaging tool. The Ocelot PIXL System is intended to cross chronic total occlusions in the peripheral vasculature while simultaneously providing OCT visualization to help orient the distal tip of the Ocelot PIXL to support the primary intended use. Use of Ocelot PIXL in conjunction with Lightbox allows for OCT imaging as an adjunct to fluoroscopy which facilitates intravascular orientation of the catheter. See Lightbox Operator’s Manual and Umbilical IFU for guidance on setting up and using the Lightbox and Umbilical, respectively. Ocelot PIXL is available in 2 different lengths, 135cm working length and 150cm working length.Ocelot PIXL is an over-the-wire device compatible with a 5F sheath and 0.014” guidewire. It consists of a catheter shaft with handle assembly at the proximal end and a distal tip designed to cross CTOs. A locking luer connecter at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire (i.e., Lumen Flush Port). The catheter is sterilized by ethylene oxide and is intended for single use only. "
Lightbox Umbilical is intended for use in peripheral vascular procedures in conj
Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a compatible Avinger product.