February 2, 2021—Cardio Flow, Inc., announces completion of the enrollment phase of its FreedomFlow® Orbital Atherectomy device within its FAST II clinical trial, “Evaluation of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System to Treat Peripheral Artery Disease.”

The study is evaluating the safety and effectiveness of the Cardio Flow FreedomFlow Orbital Circumferential Atherectomy System for atherosclerotic plaque removal and vessel compliance modification in de novo native target lesions in the peripheral vasculature of the lower extremities.

The study enrolled a total of 112 patients at 13 locations with 25 physicians in the United States, and evaluated both an electrically powered and a pneumatically powered user handle.

September 30, 2020—Cardio Flow, Inc., announced today that it has received approval by the U.S. Food and Drug Administration (FDA) for the addition of an electrically powered variation of its FreedomFlow® Orbital Atherectomy device to its investigational plan for its FAST II Trial, “Evaluation of the Cardio Flow FreedomFlow® Orbital Circumferential Atherectomy System to Treat Peripheral Artery Disease”.

The electrically powered user handle will be added to the study, which includes the previously approved pneumatically powered user handle.

The new user handle features an integrated electric motor and a nonsterile, reusable power supply. The approval was granted by the FDA on September 25, 2020.

Device indications for use: The FreedomFlow® Orbital Circumferential Atherectomy System is applied as therapy to remove atherosclerotic plaque within peripheral arterial vessels. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

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

August 17, 2018—Cardio Flow, Inc., announced today the start of its FAST II trial to evaluate the safety and effectiveness of its FreedomFlow® Orbital Atherectomy System for atherosclerotic plaque removal in subjects diagnosed with peripheral arterial disease of the lower extremities. Cardio Flow will begin enrolling patients for this study in late 2018.

Study Objective: To evaluate the safety and effectiveness of the FreedomFlow system for atherosclerotic plaque removal and vessel modification in de novo target lesions in the peripheral vasculature of the lower extremities.

Investigational Product: Cardio Flow FreedomFlow® Orbital Atherectomy System

• CM1001 – Control Module and Tubing Set
• H4001 – User Handle

Study Design: Prospective, multi-center, non-randomized single-arm study.

Enrollment Size and Number of Sites: Up to 112 participants at 10 locations in the United States.

Primary Outcome Measures:

• Technical success, is defined as the ability of the Cardio Flow FreedomFlow® Orbital Circumferential Atherectomy System to achieve a residual diameter stenosis ≤ 50% without adjunctive therapy, as assessed by an independent Angiographic Core Laboratory.
• Primary safety endpoint is freedom from a composite of new onset major adverse events (MAE) at 30 day follow-up, as adjudicated by an Independent Clinical Events Committee.

Study Duration: Enrollment will begin in December, 2018, and estimated to continue through early 2021.

See full study details at ClinicalTrials.gov.

Device indications for use: The FreedomFlow® Orbital Circumferential Atherectomy System is applied as therapy to remove atherosclerotic plaque within peripheral arterial vessels. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

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

December 7, 2017—Cardio Flow, Inc., announced today that it had received approval from the FDA of an Investigational Device Exemption (IDE) for its FreedomFlow® Orbital Atherectomy System First-in-Human (FIH) clinical trial. Cardio Flow will soon begin enrolling patients for this First-in-Human FAST Trial. The FDA approval was granted on on November 21, 2017.

Study Objective: To evaluate first-in-human safety and effectiveness of the Cardio Flow FreedomFlow® Orbital Atherectomy System for atherosclerotic plaque removal in de novo native target lesions in the peripheral vasculature of the lower extremities.

Investigational Product: Cardio Flow FreedomFlow® Orbital Atherectomy System.

• CM1001 – Control Module and Tubing Set
• H4001 – User Handle

Study Design: Prospective, 2 centers, non-randomized single-arm study.

Enrollment Size and Number of Sites: Up to 10 subjects at up to 2 sites in the United States.

Primary Effectiveness: Technical success, defined as the ability of the Cardio Flow FreedomFlow® Orbital Atherectomy System to achieve a residual diameter stenosis ≤50% post treatment with or without adjunctive therapy, as assessed by an independent Angiographic Core Laboratory.

Study Duration: Enrollment is expected to take approximately 2 months, with observation periods at time of procedure, pre-discharge, 30 days, and 6 months post-procedure follow-up.

See full study details at ClinicalTrials.gov.

Device indications for use: The FreedomFlow® Orbital Circumferential Atherectomy System is applied as therapy to remove atherosclerotic plaque within peripheral arterial vessels. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

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