CereVasc says a new study showed 95% of participants clinically improved through 90 days of follow-up with the company’s eShunt System.
The prospective, multi-center, single-arm clinical study, published in the Journal of NeuroInterventional Surgery (JNIS), involved 66 people with normal pressure hydrocephalus (NPH) treated at 12 sites in the United States and Argentina. Boston-based CereVasc describes eShunt as the first new treatment option developed for communicating hydrocephalus since the VP shunt was introduced more than 60 years ago.
Key study results through 90-day follow-up included:
- 0% rate of device-related serious adverse events (SAEs);
- 3% rate of procedure-related SAEs, all resolved without surgical intervention;
- 95% of participants demonstrated improvement in at least one of the three primary clinical symptoms of NPH (gait disturbance, cognitive impairment, and urinary incontinence);
- Statistically significant improvement from baseline in all three primary clinical symptoms of NPH;
- Zero observations of symptomatic or radiologic cerebral hemorrhage or over-drainage, confirmed by blinded, independent core lab MR and CT image analysis;
- Zero instances of infection related to the procedure or device.
“The outcomes achieved in this study are highly encouraging. The favorable safety profile, along with statistically significant symptom improvements observed at the 90-day follow-up, provides an early clinical signal that supports continued evaluation of an endovascular approach for the treatment of NPH,” Dr. Charles Matouk, vice chair of clinical affairs of neurosurgery and chief of neurovascular surgery at the Yale School of Medicine, said in a news release.
CereVasc CEO Dan Levangie said he’s eager to further evaluate results from the STRIDE randomized, controlled pivotal trial, which is presently enrolling patients at 28 sites in the United States, Argentina, and Canada. “The STRIDE trial is the first head-to-head comparison of conventional shunting to the minimally invasive eShunt System, and with the data generated to date and enthusiasm from practitioners and patients, we remain focused on advancing this innovation toward a potential new standard of care for patients with NPH.”
STRIDE trial results will support CereVasc’s anticipated regulatory submissions for the eShunt System.
