Cardio Flow, Inc., Announces FDA Clearance for FreedomFlow® Peripheral Guidewire, plus First Commercial Case Completed in U.S.
ST. PAUL, Minn.–(BUSINESS WIRE)–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® Peripheral Guidewire.
The FreedomFlow guidewire is stainless steel core-to-tip design with a fixed distal-spring coil which was developed to provide exceptional support for diagnostic and therapeutic devices used in treating plaque blockages in arteries both above and below the knee.
The new guidewire features a silicone-coated spring coil along with a silicone coating on the distal 200cm that eases the crossing of difficult blockages. Furthermore, the 0.014-inch core-to-tip design provides interventionists superior torque transmission and precise control when delivering therapeutic devices.
First Commercial Case
This week Dr. Jihad Mustapha, MD, FACC, FSCAI, the Director of Endovascular Interventions at Advanced Cardiac & Vascular Centers for Amputation Prevention in Grand Rapids, MI, completed the first commercial case with the new guidewire on a patient presenting with complex multi-vessel disease with blockages below the knee, requiring a pedal loop.
Dr. Mustapha was impressed with the trackability and versatility of the FreedomFlow guidewire, noting, “I was able to deliver three PTA balloons, one IVUS 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, commented, “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 (CLI). We look forward to bringing this advancement in guidewire technology to our U.S. customers with a limited market release, followed by expanded commercial efforts in 2022.” cardioflow.net/products/freedomflow-peripheral-guidewire
About Cardio Flow, Inc.
Cardio Flow, Inc., is a privately held medical device company that develops minimally invasive peripheral vascular products. The FreedomFlow® Peripheral Guidewire is the first of several devices in development to treat Peripheral Artery Disease (PAD). See www.cardioflow.net for more information.
About Advanced Cardiac & Vascular Centers© (ACV)
Launched in February 2018, Advanced Cardiac & Vascular Centers for Amputation Prevention provides highly personalized and comprehensive cardiac, vascular, and vein care. Co-founded by Dr. Jihad Mustapha and Dr. Fadi Saab, ACV Centers has a special concentration on treating peripheral artery disease and the complications of critical limb ischemia. For further information, visit www.acvcenters.com.
Contacts
Scott Kraus
VP Sales & Marketing
Cardio Flow, Inc.
Tel: (610) 247-3173
Email: [email protected]
