Cook iMRI Needles NSR Clinical Study

Inclusion criteria

Patient is suitable for inclusion in the study if the patient meets the following criteria:

• A qualified physician directs the patient to have a procedure that requires a needle

for percutaneous access, aspiration, and/or injection during therapeutic or diagnostic interventional MRI-guided procedures

• Patients, or their legally authorized representatives, must also voluntarily consent to participate in the study

Exclusion criteria

• Inability or refusal to give informed consent by the patient or legally authorized representative
• Age < 18 years
• Vulnerable population (specifically prisoners, lactating women and/or cognitively impaired patients)
• Patients lacking a safe trajectory to the target tissue, as determined by the physician
• Patients with uncorrectable coagulopathy
• Allergy to the device or contrast media that cannot be adequately premedicated
• Body habitus or medical condition that compromises or prevents necessary imaging procedures
• Body weight exceeding limits of available MRI machines
• Target lesion is unable to be reached by the longest needle (or in combination with a core biopsy device)
• Implanted non-MR conditional device or other metallic device (e.g., certain pacemakers, aneurysm clips, cochlear implants, and/or mechanical heart valves)
• Inability of the patient to cooperate with, or to be positioned for, the procedure