Cardio Flow has announced it recently received US Food and Drug Administration (FDA) clearance for the company’s FreedomFlow peripheral guidewire.
According to a company press release, the FreedomFlow guidewire features a stainless steel core-to-tip design with a fixed distal-spring coil which was developed to provide 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, the release adds. Furthermore, it states that the 0.014-inch core-to-tip design provides interventionists superior torque transmission and precise control when delivering therapeutic devices.
Cardio Flow has also revealed that Jihad Mustapha (Advanced Cardiac & Vascular Centers for Amputation Prevention, Grand Rapids, USA) recently 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.
Mustapha was impressed with the trackability and versatility of the FreedomFlow guidewire, the company reports, noting, “I was able to deliver three PTA [percutaneous transluminal angioplasty] balloons, one IVUS [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.”