Cardio Flow’s FreedomFlow Peripheral Guidewire Receives FDA Clearance

June 2, 2022—Cardio Flow, Inc., a developer of minimally invasive peripheral vascular devices to treat peripheral artery disease (PAD), announced it received FDA clearance for the company’s FreedomFlow peripheral guidewire.

According to Cardio Flow, the FreedomFlow guidewire features a stainless steel, core-to-tip design with a fixed distal-spring coil that was designed to provide support for diagnostic and therapeutic devices used in treating plaque blockages in arteries both above and below the knee. The device has a silicone-coated spring coil along with silicone coating on the distal 200 cm that eases the crossing of difficult blockages. The 0.014-inch core-to-tip design provides superior torque transmission and precise control when delivering therapeutic devices, noted the company.

The company also reported that the first commercial case with the new guidewire was performed by Jihad Mustapha, MD, to treat a patient presenting with complex multivessel disease with blockages below the knee, requiring a pedal loop.

Dr. Mustapha, who is Director of Endovascular Interventions at Advanced Cardiac & Vascular Centers for Amputation Prevention in Grand Rapids, Michigan, commented in Cardio Flow's press release, “I was able to deliver three percutaneous transluminal angioplasty balloons, one intravascular ultrasound catheter, and a therapeutic device across the single guidewire—all glided easily along the FreedomFlow wire. This new product has the potential to save time and costs in the endovascular lab, given its versatility in crossing occlusions and ability to deliver multiple interventional devices on a single guidewire.”

Scott Kraus, Vice President of Sales & Market for Cardio Flow, added, in the press release, “Cardio Flow is encouraged by the initial feedback from Dr. Mustapha, who is a recognized leader in the treatment of PAD and critical limb ischemia. We look forward to bringing this advancement in guidewire technology to our United States customers with a limited market release, followed by expanded commercial efforts in 2022.”