Mayo-Backed Device for Treating Deadly Type of Stroke Nearing FDA Notification

A new medical device being co-developed by the Mayo Clinic to treat an especially deadly type of stroke is on target for an initial U.S. Food and Drug Administration application in the next quarter, according to newly filed documents reported on by Twin Cities Business.
The device, called the ClearAway catheter, is being developed by a Mayo neurosurgeon at the clinic’s Scottsdale, Arizona, facility, and by MRI Interventions Inc of Irvine, California.
The two parties struck a joint development agreement last year to perfect the device, which would for the first time allow neurosurgeons to suction out blood clots in the brain while monitoring the procedure in real time via highly sensitive magnetic resonance imaging.
The device is to be used in conjunction with MRI Interventions’ ClearPoint Neuro Navigation System, which allows doctors performing brain surgery to view detailed, real-time MRI images of the brain’s interior, better enabling them to carry out precise, minimally invasive procedures.
ClearAway is a “neuro-aspiration device” meant to provide a new therapy for spontaneous intra-cerebral hemorrhage (ICH), the most serious subtype of stroke.
ICH afflicts between 200,000 and 300,000 Americans each year and has a fatality rate of up to 50 percent of all occurrences, but it’s also the only major stroke subtype without a clearly effective current treatment. Its deadly nature is due to the accumulation of blood that clots in the brain, which compresses the adjacent brain tissue and proves toxic to brain cells surrounding the damaged area.
One of the effort’s lead developers is renowned Mayo neurosurgeon Dr. Bernard Bendok. It is part of five-year company strategy of expansion into the therapeutics market.
MRI’s latest quarterly filing with the U.S. Securities Exchange Commission  indicated the company is on a fast track for filing a pre-market notification with the FDA known as a 510(k) submission, which is the first step to having a medical device cleared for patient use.
The 20-year-old company reported a net loss of $1.6 million on revenues of $2 million during the first quarter, with research and development costs of $546,000. It reported $910,000 of cash on hand and the completion of an internal corporate restructuring, which Burnett called “hitting the reset button” after failing to meet “our internal targets” for generating new cases for the ClearPoint system.