US-based medical devices firm Insera Therapeutics has received Conformité Européenne (CE) mark approval for its CLEAR Aspiration System, a cyclical-suction stroke thrombectomy platform.
Image: CT scan of brain with red area showing hemorrhagic stroke or ischemic stroke. Photo: Courtesy of stockdevil/FreeDigitalPhotos.net.
Insera’s aspiration technology offers cyclical aspiration, an ability to vary vacuum suction pressures and intervals within the safe vacuum suction range up to -98.2 kPa.
CLEAR Aspiration System is used in aspiration of blood clots, in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease, secondary to cerebral venous sinus thrombosis, and electively for staged aspiration through a balloon guide or guide catheter within the neck arteries.
The company said that a recent study using the CLEAR Aspiration System showed that complete clot ingestion with cyclical aspiration increases the chances for full vessel re-opening using a single retrieval attempt (first-pass recanalization) and reduces clot fragmentation unlike static aspiration.
Insera secured approvals based on mechanical bench tests, safety and efficacy tests conducted in premier stroke device testing centers including Intertek Electrical in Menlo Park, California, Mayo Clinic in Rochester, Minnesota, New England Center for Stroke Research (NECStR) in Worcester, Massachusetts, and The Jacobs Institute in Buffalo, New York.
The Jacobs Institute chief medical officer and SUNY at Buffalo neurosurgery professor Dr. Adnan Siddiqui said: “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.”
In addition to the aspiration of blood clots, the aspiration system has acquired CE Mark approval for use in aspiration of tissue and fluids.
Insera’s aspiration system is directed for use in patients with hemorrhagic stroke or brain bleeds, for the controlled aspiration of tissue and/or fluid during surgery of the ventricular system or cerebrum, during neurosurgical, neuro-endoscopic, and other surgical procedures, like aspiration of tissue, fluids, tumor, and abscess.
The CLEAR Aspiration System has also received a European regulatory approval for the aspiration of foreign bodies in addition to blood clots, and is indicated for use for foreign body retrieval in the peripheral, neuro, and cardiovasculature.
It is used in aspiration of blood clots from arteries for patients with peripheral artery disease, pulmonary embolism, and coronary artery disease, and for the aspiration of blood clots from veins in patients with deep venous thrombosis, or with renal failure who have clotted hemodialysis grafts.
Insera Therapeutics CEO Vikram Janardhan said: “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.”