Balt today announced that it has completed enrolment in its FIRST study—an observational, prospective, multicentre, international, single-arm study aiming to collect safety and efficacy information on the use of the company’s Silk Vista and Silk Vista Baby flow diverters, and continue to assess clinical safety and performances of these devices for treating intracranial aneurysms.
The FIRST study is designed to collect data for up to five years, with the primary endpoint being assessed at one year, according to a Balt press release. It involves 29 global sites, including in France, Germany, Austria, Belgium, The Netherlands, Spain, Italy, Croatia, and Israel, with a large cohort of 234 patients.
“The Silk Vista Baby and Silk Vista devices have changed the paradigm of the conventional flow diversion approaches, strategies, and indications, so we consider them a true game-changer for both patients and neurointerventionalists,” said FIRST principal investigator Mario Martínez-Galdámez (Hospital La Luz/Hospital Valle del Henares, Madrid, Spain). “I am very excited to have achieved this important milestone together with the other investigators, as the results will provide significant value to our understanding of the role of flow diverters in anatomical locations that have not been well-studied.”
“We are thrilled to have completed the enrolment in the FIRST study, and we would like to thank and congratulate all the investigators and their teams for their fantastic and valuable efforts,” said Pascal Girin, president and CEO at Balt. “We are proud to offer the Silk Vista technology as a solution for cerebral aneurysms and look forward to making our novel flow diverter technology available globally.”