Baystate Health First in U.S. to Enroll Patients in PIONEER Aneurysm Trial
Springfield, Mass. – September 25, 2026 -- Baystate Health has become the first hospital in the United States to enroll patients in the PIONEER trial, a national study evaluating Balt Corporation's Silk Vista Baby flow-diverting stent for unruptured brain aneurysms in small blood vessels, treating its first three patients within days of receiving approval.
Baystate enrolls first three U.S. patients in national aneurysm device trial
The PIONEER study is a prospective, multicenter, single-arm trial spanning 35 leading centers in the United States and 5 in Canada, designed to assess the safety and efficacy of the Silk Vista Baby device. Balt Corporation launched the trial to satisfy FDA requirements for broader U.S. market access after the device received full approval from the Centers for Medicare & Medicaid Services following a prolonged review process.