Sensome has announced its Clotild Smart Guidewire System—designed to improve the treatment of ischaemic stroke patients—has been granted a Breakthrough Device designation by the Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH).
“This is a tremendous recognition by the FDA that will boost our efforts to bring Clotild to patients in the USA,” said Franz Bozsak, CEO and co-founder of Sensome. “The first-in-human clinical trial of Clotild is expected to start later this year outside the USA, which will take our device one step closer to improving care for ischaemic stroke patients around the world.”
Acute ischaemic stroke, a leading cause of long-term disability, can be treated by removing the clot blocking the brain blood vessel using mechanical thrombectomy devices, which are guided from the groin over a wire to the blockage. To improve patient prognosis, the clot needs to be removed as fast as possible.
However, today, without knowledge of the clot’s characteristics, the clot can only be removed on the first attempt in one out of three cases, according to a Sensome press release. The Clotild Smart Guidewire System integrates Sensome’s AI-powered tissue sensor, enabling the guidewire to provide physicians with critical information on the clot.
The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, or conditions. As part of this programme, the FDA will provide Sensome with priority review and interactive communication on its path from device development to commercialisation.