Stryker (NYSE:SYK) today released results from the post-market Weave trial of its Wingspan stent system designed for treating intracranial atherosclerotic disease.
Data from the study was presented at the International Stroke Conference, the Kalamazoo, Mich.-based company said.
The Weave trial is a multi-center, prospective, post-market surveillance study which aimed to evaluate rates of stroke or death within 72 hours in patients treated with the Wingspan stent system.
Results from the FDA-mandated trial indicated that patients receiving treatment with the Wingspan stent system had a 2.6% rate of stroke or death, lower than the 4% pre-specified rate for early success. The 4% rate was significant when compared to the trials null hypothesis with high predictive probability rate that the true rate was 9.7%, the company said.
Trial investigators said that results from the trial could lead to a shift in how physicians approach patient selection for endovascular therapy to treat ICAD.
“These trial results have the potential to change how stroke patients are treated in the future. Using approved stents in the brain arteries may give new hope to patients suffering from stroke due to blockages from cholesterol plaque,” principal investigator Dr. Michael Alexander of Los Angeles’ Cedars-Sinai Neurovascular Center said in a prepared statement.
“The Weave Trial results are a great step forward for the treatment of intracranial atherosclerotic disease. The unprecedented low complication rate shows that endovascular treatment may play an important role in optimizing clinical outcomes for patients suffering from this highly complex disease,” Stryker neurovascular division prez Mark Paul said in a press release.
Earlier this month, Stryker saw shares fall slightly despite announcing preliminary fourth quarter and full year 2017 sales results that met quarterly and yearly sales expectations.
