FFR Link and
COMET™ Pressure Guidewire
Indications Safety and Warnings
FFR Link: Intended Use/Indications for Use: The FFR Link is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab™ POLARIS Multi- Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable. Contraindications: The FFR link has no patient alarm functions and should not be used for cardiac monitoring. Warnings and Precautions: Use only a Boston Scientific COMET Pressure Guidewire or other Boston Scientific pressure guidewire with the FFR Link. Use of pressure guidewires from other manufacturers will provide inaccurate pressure readings. The FFR Link maintains a floating double-insulated patient isolation connection. This connection is intended for defibrillator-proof direct cardiac application (type CF), and includes circuitry to limit the patient leakage current to the levels specified in UL2601-1, EN60601-1, and JIS-T-060101.
COMET Pressure Guidewire: Intended Use/Indications for Use: The COMET Pressure Guidewire measures blood pressure gradient across coronary and peripheral lesions during endovascular procedures. FFR (Fractional Flow Reserve) pressure guidewire may also be used as a coronary or peripheral guidewire for interventional treatments. The COMET Pressure Guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels. Contraindications: The COMET Pressure Guidewire is contraindicated for use in the cerebral vasculature. Warnings: • Resulting pressure guidewire fractures might require additional percutaneous intervention or surgery. • Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. • Severe reaction may occur in response to contrast agents that cannot be adequately premedicated. Precautions: Maintain diligent control of the distal tip at all times during an intervention to avoid vessel dissections and perforations. When crossing a stent, exercise care to avoid entanglement between the pressure guidewire and the stent. Avoid abrasion of the pressure guidewire coating. • To avoid damage to the hydrophilic coating, do not withdraw or manipulate the pressure guidewire in a metal cannula or sharp object. • Excessive tightening of the torque device onto the pressure guidewire may result in abrasion of the coating on the pressure guidewire. Use only the optical cable provided to connect the pressure guidewire to FFR Link. Use of a different optical cable will produce inaccurate pressure readings. The accuracy of the diagnostic information is affected by, but not limited to: • Failure to achieve maximum coronary and myocardial hyperemia. • Interventional devices, such as balloon catheters, which are positioned so as to affect the blood flow or guidewires that stretch the vessel. • Pressure wire positioning relative to the lesion. • Microvascular resistance. Carefully check and match therapeutic device compatibility to the pressure guidewire prior to use. Do not use the pressure guidewire in conjunction with atherectomy catheters. Adverse Events: Potential adverse events which may result from the use of the device include but are not limited to: • Abrupt closure • Allergic reaction • Embolism • Exposure to biohazardous material • Infection • Prolonged procedure • Restenosis (reocclusion) • Spasm • Stroke/cerebral vascular accident (CVA)/transient ischemic attack (TIA) • Vascular thrombus • Vessel trauma (dissection, perforation, rupture or injury). In addition, when used for interventional procedures: • Angina or unstable angina • Arrhythmias • Cardiac tamponade/pericardial effusion • Contrast induced renal insufficiency or renal failure • Death • Myocardial infarction or ischemia. Some of the above potential adverse events may require additional surgical intervention.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.