Nano-Robot Cerebral Aneurysm Embolization System NanoClip Receives FDA Breakthrough Therapy Designation

Nano-Robot Cerebral Aneurysm Embolization System NanoClip Receives FDA Breakthrough Therapy Designation

On October 9, 2030, the FDA granted Breakthrough Therapy Designation to NanoClip, a cerebral aneurysm embolization system developed by Israeli medical robotics company Microbot Medical. NanoClip is the first micro-robotic system capable of autonomously locating aneurysms inside cerebral blood vessels and completing embolization.

Cerebral aneurysms are abnormal bulges in the walls of brain blood vessels. Rupture leads to subarachnoid hemorrhage with a mortality rate as high as 40%. Current treatment involves delivering coils through a catheter into the aneurysm sac for embolization, but this procedure depends heavily on the surgeon's hand-eye coordination and is extremely challenging in tortuous vessels.

NanoClip measures just 1 millimeter in diameter and 5 millimeters in length. After being delivered into cerebral blood vessels via a micro-catheter, it uses a built-in magnetic navigation system and micro-ultrasound probe to autonomously navigate to the aneurysm site. Upon reaching the target, NanoClip releases a biocompatible hydrogel to fill the aneurysm sac, then detaches and travels with blood flow to the lungs where it is naturally metabolized and excreted.

Microbot Medical CEO Harel Gadot said: "NanoClip's design philosophy is to delegate the most difficult navigation and positioning work to the robot. The physician only needs to set the target location at the beginning; all subsequent operations are fully autonomous."

In a clinical trial involving 45 patients, NanoClip achieved a success rate of 96% (43/45) with a complication rate of 2.2% (one case of vasospasm). Compared to traditional coil embolization's 85% success rate and 5% complication rate, NanoClip showed clear advantages.

The NanoClip system is expected to receive full FDA approval in the second quarter of 2031. Microbot Medical has signed a cooperation agreement with Medtronic, which will handle global commercialization.