Drivewire, claimed to be the first neurovascular guidewire with a controllable distal end, allows to conduct difficult neuro and peripheral vascular procedures
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Rapid Medical has secured approval from the US Food and Drug Administration (FDA) for its Drivewire, which is claimed to be the world’s first steerable neurovascular guidewire.
The new guidewire features a steerable distal tip, which has the potential to efficiently handle complex anatomical turns.
Rapid Medical stated that the new device is called as Columbus outside of the US.
The new guidewire enables physicians to control the direction and shape of the device’s tip while it is inside the vessel, thereby enabling to accurately navigate the neuro and peripheral vasculature.
The intravascular steering facilitates access to challenging anatomical locations. It will help enhance the physician’s capability to treat vascular diseases with less invasive interventional approaches.
Guidewires serve as crucial components to treat intravascular diseases such as ischemic and hemorrhagic strokes.
At present, physicians cannot directly control the guidewire tip and usually remove the guidewire multiple times to reshape it before reaching the required location.
Drivewire is claimed to be the first neurovascular guidewire with a controllable distal end, which has the capacity to change course and shape on-demand for more accurate navigation. It will help physicians to select the better route to the anatomical site.
In a statement, New York’s NYU Langone neurosurgeon Dr Erez Nossek said: “The development of Drivewire has been an exciting collaboration. I can now easily navigate through complex anatomies by varying the shape of the wire tip inside the vessel, something that can’t be performed with the current neurovascular guidewires.
“I expect this first-of-its-kind technology to benefit patients with challenging anatomies and increase the interventional treatment options available to them.”
In April 2019, Rapid Medical secured $20m series C financing to accelerate its minimally invasive stroke treatment and prevention products across the globe.