FreedomFlow System
Orbital Atherectomy System for the Treatment of Peripheral Artery Disease
User Handle, Driveshaft, Tubing Set, and Power Supply
The FreedomFlow® system is a minimally invasive, catheter-based endovascular device for removing atherosclerotic plaque from peripheral arterial blood vessels within the body.
FreedomFlow treats a wide range of vessel sizes above and below the knee and may provide more efficient removal of plaque with less run time than existing orbital atherectomy treatments.
CAUTION: Investigational device. Limited by United States law to investigational use.
System Components
User handle
Controls rotational and translational movement of the driveshaft
The single-use user handle with integrated electric motor and saline pump provides control over the rotational and translational movement of the integrated driveshaft.
The blue button on the user handle activates the rotation of the driveshaft; rotation stops when the button is released.
Two user handles are available to treat a wide range of vessel sizes— from 2 mm to 8 mm:
- User Handle H6001 (5 Fr introducer) is approx. 1.5 mm (0.062″) in diameter and treats vessels 2 mm – 4 mm in diameter with a 150 cm working length
- User Handle H6002 (6 Fr introducer) is approx. 2.0 mm (0.082″) in diameter and treats vessels 4 mm – 8 mm in diameter with a 135 cm working length
Driveshaft
Multi-strand cable drives the rotation of the diamond coated spheres
The driveshaft is a hollow, multi-strand cable that drives the rotation of the diamond-coated spheres. The off-axis eccentric attachment of the spheres onto the driveshaft moves the spheres in an outward direction during rotation due to centrifugal force.
There are five spheres attached to the driveshaft in a spiral configuration. This creates an outward angular momentum during rotation, while the spacing of the spheres provides flexibility.
The diamond-coated distal hypotube (tip) is designed to ease transition into a tight vessel blockage.
This driveshaft is part of the user handles H6001 and H6002.
Tubing set
Delivers saline to the user handle
The tubing set acts as a conduit for standard saline solution to the saline pump, which is integrated into the user handle.
This item is provided sterile with the packaged user handles H6001 and H6002.
Power supply
Delivers direct-current power to the user handle
The power supply is a re-usable, non-sterile component that provides DC power to the FreedomFlow user handle.
It consists of an electrical cord, an AC-to-DC Medical Grade Class II power converter, and a bracket for attaching the power supply to a standard hospital bed.
Model number H7001