The FreedomFlow™ Orbital Atherectomy System

Cardio Flow’s FreedomFlow Orbital Atherectomy System, including the user handle, control module, and tubing set

FreedomFlow treats atherosclerosis in a wide range of artery sizes

Atherectomy is a minimally invasive endovascular (in-the-vessel) technique for removing arterial plaque, which can block blood flow to parts of the body. Currently there are four minimally invasive techniques for removing this plaque—directional, laser, rotational, and orbital:

  • Directional atherectomy devices use a shaving technique to cut and remove the plaque.
  • Rotational atherectomy devices use a rotating blade or diamond-coated burr on the tip of the device to cut or sand the plaque away.
  • Orbital atherectomy devices use a diamond-coated sanding element that is attached to the side of the device; the element is then rotated in an orbital (eccentric) technique that enables it to adjust to the size of the vessel being treated.
  • Laser atherectomy devices use light energy to vaporize the plaque.

Atherectomy devices currently on the market do not remove plaque as efficiently as physicians would prefer. This is especially the case for mineralized calcium deposits and for blockages in large-diameter vessels above the knee, such as the common femoral artery in the thigh and the common iliac and external iliac arteries in the pelvis.

The ability to treat these vessels is important because they provide access to the smaller vessels further down the leg—but most current devices can only treat vessels up to 5 mm in diameter.

Cardio Flow’s First-in-Human study will focus on treating peripheral arteries from 2mm-5mm. This pivotal study will include a wide range of vessels both above and below the knee—including larger arteries up to 8mm in diameter.

FreedomFlow is the first atherectomy device that can remove or modify all types of plaque—including calcified and fibrotic plaque—in a wide range of vessel sizes.

CAUTION: Investigational device. Limited by United States law to investigational use.

Read about what makes Cardio Flow’s FreedomFlow unique.

System Components

User Handle

Control Module & Tubing Set