Insera Therapeutics (Sacramento, Calif.) recently announced that it has received CE Mark approval for its Clear Aspiration System.
The system is designed for blood clots and has been indicated for use in patients who have acute ischemic stroke secondary to intracranial large vessel occlusive disease, secondary to cerebral venous sinus thrombosis and for staged aspiration through a balloon guide or guide catheter in neck arteries. It features varying vacuum suction pressures and intervals in a safe vacuum suction range up to -98.2 kPa.
A recent study has shown that complete clot ingestion with cyclical aspiration increases the first-pass recanalization and reduces clot fragmentation when using the Clear Aspiration System.
“The Clear Aspiration System includes a best-in-class, next-generation vacuum aspiration system that allows operators to employ uniform suction or cyclical suction patterns. The digital pump is powerful, easy-to-use and can be operated remotely from an iPad, giving it an advantage over its competitors,” said Dr. Adnan Siddiqui, a doctor at Jacobs Institute’s Chief Medical Officer and SUNY at Buffalo Professor of Neurosurgery who performed the catheterizations.
The system has received CE Mark approval for the aspiration of tissue and fluids, as well as blood clots. It is indicated for use in patients with hemorrhagic stroke or brain bleeds, controlled aspiration of tissue and fluid during ventricular system or cerebrum surgery. It has also been approved for use during neurosurgical, neuro-endoscopic and other surgical procedures.
“Clear’s proprietary power electronics technology for vacuum aspiration allows for the customization of both uniform and variable suction pressures within the safe vacuum suction range, all with an eye towards improving complete clot ingestion and a higher first-pass effect,” Vikram Janardhan, CEO of Insera Therapeutics, said in a press release.