Advanced neurovascular devices developer Rapid Medical has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Comaneci embolisation assist device.
Comaneci is designed to enable treatment of cerebral vasospasm after hemorrhagic stroke.
It is available in Europe for vasospasm intervention and is claimed to be the first device that enables physicians to apply incremental adjustments and monitor vessel expansion.
With a low delivery profile, adjustable diameter and good visibility, the device helps to enhance treatment with combination therapies.
Comaneci works as a temporary device and provides a treatment modality that could prevent the need for permanent devices, which are implanted in the brain.
University of Pennsylvania neurosurgeon Brian Jankowitz said: “Comaneci is the first device to provide combination therapy to the brain with an adjustable diameter/radial force that may lower the risk of vessel injury.”
Rapid Medical reported that 97% of patients showed at least a 25% increase in vessel opening, while 80% showed an increase of 50% or more in a multi-centre retrospective analysis conducted in 30 patients.
In addition, more than 10,000 procedures across the world have used Comaneci for assistance in the coil embolisation of wide-neck intracranial aneurysms.
Rapid Medical Americas president James Romero said: “This breakthrough designation will help expedite the availability of Comaneci, potentially providing a safer option for these sick patients.
“It underscores how we pioneer tools that provide physicians with greater control and expand treatment options tailored to patients.”
The company stated that Comaneci improves safety and efficacy in cerebral vasospasm and provides advantages over the existing technology.