Firefighter™ Pro PTCA Balloon Catheter

The Firefighter Pro PTCA Balloon Catheter is a rapid exchange catheter with a semicompliant balloon designed for coronary angioplasty. It is indicated for balloon dilation of stenotic coronary arteries or bypass grafts to improve blood flow to the heart muscle. The device features a dual-lumen shaft with PVP hydrophilic coating to reduce friction and enhance crossing capability through blood vessels.

The Firefighter Pro shares the same rapid exchange design, catheter design, guidewire compatibility (≤0.014 inch), and ethylene oxide sterilization method as the predicate TREK & MINI TREK RX devices. Key differences include different balloon diameters and lengths, shelf life, balloon nominal and rated burst pressures, and catheter materials used in construction.

Testing was performed according to the FDA's Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 2010). Biocompatibility testing followed current standards including cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogen, and hemocompatibility assessments.

The nonclinical bench and biocompatibility tests demonstrate that the Firefighter Pro is substantially equivalent to the legally marketed TREK & MINI TREK RX predicate device. Despite differences in balloon specifications and materials, the device maintains the same fundamental rapid exchange design, function, and sterilization method, with all testing meeting applicable FDA guidance requirements.