MIVI Neuroscience’s next-generation DAISe blood clot management system has had its first-in-human use for treatment of ischemic stroke.
The procedure took place in South America, the company said in a statement. DAISe is designed to remove a clot as well as filter and capture clot emboli that fracture during removal. It has a three-dimensional, vessel-conforming meshwork of hundreds of polymeric fibers that act as a mechanical backstop to capture debris as small as 40 um while maintaining blood flow through the device. Device delivery is similar to that of a stent retriever.
DAISe offers unique features and benefits not available today in ischemic stroke treatment, according to MIVI CEO Jim McCollum. “We look forward to developing the DAISe device and ultimately delivering it to the worldwide neurovascular community to help improve patient outcomes, and more specifically, not just achieving short-term patency by removing clot, but ultimately improving a stroke patient’s functional outcomes by managing or even eliminating distal embolic fragments,” McCollum said in the statement.
Efforts to minimize the effects of blood clots in ischemic stroke range from clot-busting drugs to clot-retrieval systems to the type of technology that MIVI has developed. Time is of the essence in preventing the debilitating and sometimes deadly effects of stroke, and major medtech manufacturers have been continuously upgrading their clot-fighting technologies.
Stryker recently won an expanded CE Mark indication in the European Union for its Trevo thrombectomy device as a front-line treatment for acute ischemic stroke patients for up to 24 hours from symptom onset. Earlier this year, Medtronic (NYSE:MDT) won 510(k) clearance from the FDA for its Riptide clot aspiration device for treating ischemic stroke.
MIVI (Eden Prairie, Minn.) plans to pursue more clinical trials based on the outcomes of this series, as well as those of previous in vivo and animal studies. The device is still in development and not available for sale.
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