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The FreedomFlow Orbital Atherectomy System

Cardio Flow’s FreedomFlow® Orbital Atherectomy System— including user handle, diamond-coated spheres on driveshafts (5 Fr and 6 Fr), reusable electric power supply and mounting bracket, and saline infusion tubing set.

What is FreedomFlow?

Cardio Flow’s FreedomFlow® is an atherectomy device that can remove arterial plaque that can block blood flow to parts of the body. There are five minimally invasive techniques for removing this plaque, but current devices on the market do not remove it as efficiently as physicians may prefer.

This is especially the case for mineralized calcium deposits and blockages in large-diameter vessels above the knee, such as in the common femoral artery in the thigh and the common iliac and external iliac arteries in the pelvis.

The ability to treat these larger vessels is important because they provide access to smaller vessels down the leg—but current devices on the market may not treat vessels above 5 mm in diameter effectively.

Cardio Flow’s FreedomFlow® aims to provide safe and effective treatment for removing calcified plaque from a wide range of vessels, both above and below the knee—including larger arteries up to 8mm in diameter.

What makes Cardio Flow’s FreedomFlow system unique?

Cardio Flow’s FreedomFlow orbital atherectomy system includes a number of important innovations that give physicians the ability to modify or remove all types of plaque—including calcified and fibrotic plaque—in a wide range of vessel sizes.

Multiple diamond-coated spheres for effective treatment of difficult-to-remove plaque

Cardio Flow’s FreedomFlow technology features up to five diamond-coated abrasive spheres mounted eccentrically (off center) on the driveshaft. When rotated, these spheres move outwards due to centrifugal force, providing multiple, simultaneous contacts with the vessel wall.

This may provide greater efficiency in removing both fibrotic and calcified plaque as well as reduce procedural run times, which may enhance patient outcomes.

Since plaque removal by atherectomy is often followed by balloon angioplasty to compress residual plaque against the vessel wall, FreedomFlow’s diamond-coated spheres may also prove effective in creating micro-cracks in calcified plaque. This could enable physicians to use lower-pressure balloons—improving patient safety and the effectiveness of the treatment.

Dynamic rotational design enables treatment in arteries up to 8 mm

The spiral pattern created by Cardio Flow’s rotating spheres also maximizes the dynamic motion of the outward force—the driveshaft coil is wound so that it “opens up” during rotation, further forcing the spheres in an outward direction.

This outward force is also greater and more predictable than competitive technology and may remove plaque particles at a more efficient rate.

FreedomFlow can thus achieve larger orbits at lower speeds, enabling physicians to potentially treat larger vessels using smaller devices.

Innovative driveshaft tip helps access blocked arteries

The Cardio Flow FreedomFlow device incorporates an innovative diamond-coated hypotube at the tip of the driveshaft. This helps ease the tip through tight blockages, improving access into areas that are even smaller than the sphere diameter.

Lower orbital speed and saline-only infusion simplifies set-up and reduces cost

Cardio Flow’s innovative driveshaft design, along with lower rotational speeds, enables FreedomFlow to function with standard saline solution rather than the oil-based lubricants required by other commercially available rotational and orbital technologies.

This helps to reduce operational costs and patient exposure to foreign materials.

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


FreedomFlow® System

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Orbital atherectomy refers to a method physicians may use in removing plaque from an artery.

There are five types of atherectomy devices currently on the market. Each uses a different approach:

  • Directional atherectomy devices use a shaving technique to cut and remove plaque.
  • Rotational atherectomy devices use a rotating blade or diamond-coated burr on the tip of the device to cut or sand 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 plaque.
  • Intravascular lithotripsy devices use sonic pressure waves to break up plaque.