Rapid Medical, a developer of neurovascular devices, has received the US Food and Drug Administration (FDA) breakthrough device designation for its Comaneci embolisation assist device.
Comaneci is designed to treat cerebral vasospasm, a major complication and cause of morbidity, following haemorrhagic stroke. It is available in Europe.
The device comes with an adjustable diameter, low delivery profile and superior visibility, which drawn the demand from physicians worldwide.
It is a temporary device, and provides a treatment modality that may prevent the need for permanent devices implanted in the brain, said the company.
University of Pennsylvania neurosurgeon Brian Jankowitz said: “We just need better solutions for patients–no single treatment has been shown to be uniformly safe and effective in treating symptomatic vasospasm.
“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.”
According to Rapid Medical, Comaneci is the first device to facilitate monitoring vessel expansion, incremental adjustments, and enhance treatment with combination therapeutics.
In a multi-centre retrospective analysis of 30 participants, Comaneci showed at least 25% increase in vessel opening in 97% patients, and a rise of 50% or more in 80% of patients.
The company said that more than 10,000 procedures have been performed world-wide using Comaneci to assist in the coil embolisation of wide-neck intracranial aneurysms.
Rapid Medical is engaged in developing responsive interventional devices for neurovascular diseases such as ischemic and haemorrhagic stroke.
It leverages novel manufacturing techniques for the manufacture of its products that are remotely adjustable and fully visible.
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.”
