BCV’s Gecko System for Neurovascular Procedures Used in First-In-Human Case

September 7, 2022—France-based BCV announced that the first-in-human case with the company’s Gecko system was conducted by Michel Piotin, MD, Head of Interventional Neuroradiology at Foundation Rothschild Hospital in Paris, France. BCV’s Gecko steerable mechatronic guidewires are being developed and evaluated for the treatment of stroke.

“Physicians face many challenges with neurovascular pathologies in navigating to the treatment site rapidly and safely,” commented Dr. Piotin in BCV’s press release. “Gecko, through its design versatility and electronic navigation, facilitates the management of complex arterial maneuvers, saving time and minimizing device exchanges. We are very pleased to be the first users and look forward to realizing the many benefits of this device on our patients.”

BCV advised that the Gecko system is an investigational device and is not available for commercial sale. The company intends to submit data from the first 10 patients for a CE Mark filing in September 2022 and hold an FDA presubmission meeting by the end of this calendar year.

According to the company, Gecko was designed to allow faster navigation and reduce complications, especially in tortuous vessels. It is compatible with existing catheters and image-guided platforms and has potential applications in any procedure requiring guidewire access, including cardiovascular, urological, gynecological, oncological, and bariatric procedures.