The GECKO 60 Active Wire for Neurovascular Interventions

Introduction: The GECKO 60 active guidewire is used to position a distal access catheter (DAC) from the femoral or the radial artery. The device is a system composed of a deflector (the guide) and a handle. The handle contains the battery and integrated electronics. The device can be activated electronically.

Method(s): We conducted a prospective single-center, nonrandomized, open “First in Human” study including a maximum of 10 patients. The device was used with different commercial catheters. No statistical analysis was performed, except a description with percentages, and no statistical hypothesis testing was applied. Many unwanted events can occur that are subsequently unrelated to the use of the device being tested. Therefore, it was important to justify all the origins of serious adverse events (SAE).

Result(s): Ten consented patients were enrolled and completed the clinical study. One SAE, a minor stroke related to the investigational procedure, occurred during the clinical investigation. Successful navigation was achieved in 10 patients to position the distal access catheter at the target vessel.

Conclusion(s): Based on the descriptive results, the “First-In-Human” clinical investigation with the GECKO 60 device showed that it is safe. Technical success was achieved for the 10 patients (100%).

Publication History

Article published online:
09 February 2023