News
Cardio Flow, Inc., Announces FDA Clearance for FreedomFlow Peripheral Guidewire, plus First Commercial Case Completed in U.S.
PRESS RELEASE | FOR IMMEDIATE RELEASE | Download press release St. Paul, MN – June 2, 2022 – Cardio Flow, Inc., a medical device company and developer of minimally invasive peripheral vascular devices to treat peripheral artery disease (PAD), today announced it recently received U.S. Food and Drug Administration (FDA) clearance for the company’s FreedomFlow®…
Cardio Flow to Present FAST II 30-Day Follow-Up Results at AMP Symposium in Orlando, August 11-14, 2021
July 23, 2021—Cardio Flow, Inc., will be attending the Amputation Prevention Symposium (AMP) in Orlando, Florida, August 11-14, 2021, and will be presenting the results of its 30-day follow-up study of the FAST II clinical trial of its FreedomFlow® orbital circumferential atherectomy system. Cardio Flow completed the enrollment phase of the FAST II clinical study, “Evaluation…
Cardio Flow Announces Sales and Marketing Team
July 15, 2021—Cardio Flow, Inc., announces that the following individuals have recently accepted positions in its newly established Sales & Marketing team: Scott Kraus – Vice President of Sales and Marketing Scott most recently served as Zone General Manager with Abiomed, and prior to this held senior management roles with Intact Vascular (acquired by Philips),…
Cardio Flow completes enrollment within its FAST II Clinical Trial of the FreedomFlow Orbital Atherectomy System
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…
Cardio Flow Receives FDA IDE Approval for an Electrically Powered Variation of the FreedomFlow Orbital Atherectomy System
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…
Cardio Flow Announces its FAST II Trial to Evaluate the Safety and Efficacy of the FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease (FAST II)
August 17, 2018. Cardio Flow announced the start of its FAST II trial to evaluate the safety and effectiveness of its FreedomFlow™ Orbital Circumferential 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:…
Cardio Flow Announces its FAST II Trial to Evaluate the Safety and Efficacy of the FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease (FAST II)
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:…
Cardio Flow Announces Feasibility Clinical Trial of the Cardio Flow FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease (FAST Trial)
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…