FreedomFlow Specifications
FreedomFlow Orbital Atherectomy Platform
Catheter
The single-use catheter with integrated electric motor and saline pump provides control over the rotational and translational movement of the integrated driveshaft.
Two catheters are available to treat a wide range of vessel sizes—from 2 mm to 8 mm:
5 French 5-Sphere Driveshaft
Catheter 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
6 French 5-Sphere Driveshaft
Catheter 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
Selecting Catheter and Orbital Speed for Vessel Size
5 French Catheter
Vessel diameter range (mm): 2.0 – 2.9
Device size (mm, French): 1.5, 5 Fr
Speed: LOW
Largest lumen (mm) achieved during 3-minute run time. Results based on device operation in a graphite block: Luminal gain 0.69 mm
Vessel diameter range (mm): 3.0 – 4.0
Device size (mm, French): 1.5, 5 Fr
Speed: HIGH
Largest lumen (mm) achieved during 3-minute run time. Results based on device operation in a graphite block: Luminal gain 1.18 mm
5 Fr catheter is approximately 1.5 mm (0.062″) in diameter and treats vessels 2 mm – 4 mm. A 5 Fr introducer and 0.014-inch diameter x 300 cm (minimum length) atherectomy guidewire are required. Follow manufacturer instructions related to guidewire use.
6 French Catheter
Vessel diameter range (mm): 4.0 – 5.9
Device size (mm, French): 2.0, 6 Fr
Speed: LOW
Largest lumen (mm) achieved during 3-minute run time. Results based on device operation in a graphite block: Luminal gain 1.38 mm
Vessel diameter range (mm): 6.0 – 8.0
Device size (mm, French): 2.0, 6 Fr
Speed: HIGH
Largest lumen (mm) achieved during 3-minute run time. Results based on device operation in a graphite block: Luminal gain 1.75 mm
6 Fr catheter is approximately 2.0 mm (0.082″) in diameter and treats vessels 4 mm – 8 mm. A 6 Fr introducer and 0.014-inch diameter x 300 cm (minimum length) atherectomy guidewire are required. Follow manufacturer instructions related to guidewire use.
Tubing Set
The tubing set delivers standard saline to the saline pump and is integrated into the catheter.
Electric Power Supply
The power supply is a reusable, non-sterile AC-to-DC Medical Grade Class II power converter with bracket. Model H7001.
How to Order
Please contact Cardio Flow at 800-294-5517 to order FreedomFlow® components.
Item: #H6001
Description: Electric Catheter, 5 Fr 150 cm 5-Sphere
UOM: 1/Bx
Item: #H6002
Description: Electric Catheter, 6 Fr 135 cm 5-Sphere
UOM: 1/Bx
Item: #H7001
Description: Electric Power Supply
UOM: 1/Bx
Item: #GW1001
Description: Guidewire, 325cm
UOM: 5/Bx
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
INDICATIONS FOR USE: The Cardio Flow FreedomFlow® Orbital Atherectomy Peripheral Platform is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.