First-In-Human Cases Commence With BCV’s GECKO System

BCV’s GECKO System is one step closer to commercialization, as the technology has been used for the first time in a patient.

The first-in-human case was conducted by Michel Piotin, M.D., Ph.D., head of Interventional neuroradiology at Foundation Rothschild Hospital in Paris, France. “Physicians face many challenges with neurovascular pathologies in navigating to the treatment site rapidly and safely,” said Piotin. “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.”
 
Worldwide each year more than 12.2 million people suffer a stroke¹ and the estimated global cost of strokes is more than $721 billion.¹ A key issue in stroke treatment is speed to intervene: each minute represents nearly 2 million lost neurons.² During stroke intervention, complications can arise that delay access to the clot and cause issues in patient recovery.³ Current approaches can involve excessive time and devices to obtain access to the stroke location, depending on anatomical complexity. Because “time is brain”, BCV developed the GECKO—a sterile, Class III single-use steerable mechatronic guidewire intended to facilitate the access and positioning of a catheter to reach the obstructing clot.

GECKO is designed to allow faster navigation and reduce complications, especially in tortuous vessels. GECKO 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. Originally developed with help from Institute of Intelligent Systems and Robotics (ISIR) at Sorbonne University-CNRS and INSERM, the core technology is mechatronic and can be integrated in robotic solutions.
 
BCV is a medical device company founded in 2016 with the mission to improve patient outcomes by providing simpler, faster and safer navigation for endovascular procedures. The company intends to submit data from the first 10 patients for a CE Mark filing and hold an FDA pre-submission meeting by the end of this year.
 
The GECKO System is an investigational device and is not available for worldwide commercial sale.

References 
¹ Global Stroke Fact Sheet. World Stroke Organization (WSO). 2022. www.world-stroke.org
² Saver J, et al. Stroke. 2006;37:263–266.
³ Pilgram-Pastor SM, Piechowiak EI, Dobrocky T, et al. Stroke thrombectomy complication management Journal of NeuroInterventional Surgery 2021;13:912-917.