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.

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Instructions for Use (IFU)

FreedomFlow brochure, 2-page

FreedomFlow brochure, 6-page

Three catheters are available to treat a wide range of vessel sizes—from 2 mm to 8 mm:

5 French 3-Sphere Driveshaft

Catheter H6004 (5 Fr introducer) is approximately 1.5 mm (0.062″) in diameter and treats vessels 2 mm – 4 mm in diameter with a 150 cm working length.

5 French 5-Sphere Driveshaft

Catheter H6001 (5 Fr introducer) is approximately 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 approximately 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 Catheters

Vessel diameter range: 2.0 – 3.0 mm

French size: 5 Fr
Speed: LOW
Largest lumen achieved during 3-minute run time (results based on device operation in a graphite block):
5 Fr 3-Sphere: 2.1 mm
5 Fr 5-Sphere: 2.2 mm

Vessel diameter range: 3.0 – 4.0 mm

French size: 5 Fr
Speed: HIGH
Largest lumen achieved during 3-minute run time (results based on device operation in a graphite block):
5 Fr 3-Sphere: 2.5 mm
5 Fr 5-Sphere: 2.7 mm

5 Fr catheters are approximately 1.5 mm (0.062″) in diameter and treat 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: 4.0 – 6.0 mm

French size: 6 Fr
Speed: LOW
Largest lumen achieved during 3-minute run time (results based on device operation in a graphite block): 3.4 mm

Vessel diameter range: 6.0 – 8.0 mm

French size: 6 Fr
Speed: HIGH
Largest lumen achieved during 3-minute run time (results based on device operation in a graphite block): 3.8 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 H7001 is a reusable, non-sterile AC-to-DC Medical Grade Class II power converter with bracket.

How to Order

Please contact Cardio Flow at 800-294-5517 to order FreedomFlow® components.

Call to order FreedomFlow

Item: H6004
Description: Electric Catheter, 5 Fr 150 cm 3-Sphere
UOM: 1/Bx

FreedomFlow catheter with driveshaft and tubing set

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.