Insera earns CE Mark approval for cyclical-suction stroke thrombectomy platform, the CLEAR aspiration system
April 09, 2019
SACRAMENTO, Calif.--(BUSINESS WIRE)--Insera Therapeutics, Inc. announced today that it has received Conformité Européenne (CE) Mark approval for its flagship product, the CLEAR Aspiration System, for the aspiration of blood clots, and is indicated for use in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease, secondary to cerebral venous sinus thrombosis, and optionally for staged aspiration through a balloon guide or guide catheter within the neck arteries.
This unique aspiration technology offers the ability to vary the vacuum suction pressures and intervals within the safe vacuum suction range up to -98.2 kPa (-29 inHg). A recent study using the CLEAR Aspiration System1 showed that complete clot ingestion with cyclical aspiration (namely varying the suction pressures) increases first-pass recanalization (namely ability to achieve full vessel re-opening using a single retrieval attempt) and reduces clot fragmentation compared to static aspiration (namely uniform suction pressure).
Approval was based on mechanical bench tests, safety and efficacy tests conducted in premier stroke device testing centers including: Intertek Electrical based out of Menlo Park, CA, Mayo Clinic in Rochester, MN, New England Center for Stroke Research (NECStR) in Worcester, MA, and The Jacobs Institute in Buffalo, NY.
The catheterizations in Buffalo, NY were performed by the Jacobs Institute’s Chief Medical Officer and SUNY at Buffalo Professor of Neurosurgery, Dr. Adnan Siddiqui, MD, PhD, FACS, FAHA, who noted, “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.”
The CLEAR Aspiration System has CE Mark approval for the aspiration of tissue and fluids in addition to blood clots, and is indicated 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, including aspiration of tissue, fluids, tumor, and abscess.
The CLEAR Aspiration System also has 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, for the aspiration of blood clots from arteries (e.g. in patients with peripheral artery disease, pulmonary embolism, and coronary artery disease), and for the aspiration of blood clots from veins (e.g. in patients with deep venous thrombosis, or patients with renal failure who have clotted hemodialysis grafts).
“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,” explained Vikram Janardhan, CEO of Insera Therapeutics, Inc.
Insera Therapeutics, Inc. is an ISO 13485 certified medical device company focused on treatments for vascular diseases including stroke. CLEARTM stands for Customizable, Luminal, Evacuation, Aspiration, and Retrieval. The CLEARTM Aspiration System is currently not cleared to market in the United States. InseraTM, CLEARTM, and CLEARTM Aspiration System are trademarks of Insera Therapeutics, Inc.
About the Jacobs Institute
The Jacobs Institute is a non-profit organization whose mission is to accelerate the development of next- generation technologies in vascular medicine through collisions of physicians, engineers, entrepreneurs, and industry. The JI's vision is to improve the treatment of vascular disease in Western New York and the world, while fostering local economic development. The JI fosters medical collaboration and innovation through partnerships with the University at Buffalo (UB), Kaleida Health, and industry, to be a fitting tribute to the work and memory of Lawrence D. Jacobs, M.D.
About New England Center for Stroke Research
NECStR is an image-guided surgery facility based within the University of Massachusetts Medical School that offers the latest technology in intervention to support investigators in developing minimally invasive treatments. NECStR has been fully operational since 2006. The center’s expertise and resources enable in vitro and animal modeling of vascular pathologies, multi-modal imaging, post-acquisition image processing, rapid prototyping from medical imaging and image-guided minimally invasive surgery.