Summary
In 2015, CereVasc engaged Sage to develop a minimally invasive, endovascular, catheter-based system to treat communicating hydrocephalus. Sage developed the system’s two components: a small, permanent shunt, which is implanted across the brain’s dura to drain excess cerebrospinal fluid, and the intravenous delivery system physicians use to deploy it.
Design requirements were technically complex, with size, form factor, and materials selection being critical. The delivery system would advance the implant and its own componentry smoothly through a long, tortuous path. At the target site, it needed to provide enough tension to accurately position the deployment needle and the counterforce required for it to penetrate the dura. The implant’s anchor had to expand from a compressed state once deployed. Its drainage valve needed to manage pressure differentials to allow flow only in the intended direction and at the appropriate rate. And its catheter body had to be hemocompatible to prevent thrombosis.
Working with clinicians, materials experts, and manufacturing partners, Sage analyzed the requirements and the characteristics of the tissues and organs involved, built sophisticated test fixtures to mimic conditions in the patient, developed comprehensive test methods to evaluate the system, and researched, tested, and selected the best materials for each component, ultimately developing the CereVasc® eShunt System®, which is currently in clinical trials in the US and abroad.¹
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