Study to confirm clinical benefit of Silk Vista and Silk Vista Baby in a wide range of anatomical locations
BOSTON, July 28, 2021 (GLOBE NEWSWIRE) -- Balt, an innovative neurovascular company focused on developing, designing, and manufacturing solutions for treating complex, life-threatening conditions, including stroke, aneurysms, and arteriovenous malformations, today announced enrollment in the FIRST study has been completed.
The FIRST study is an observational, prospective, multi-center, international, single-arm study with the aim of collecting safety and efficacy information on the use of the Silk Vista and Silk Vista Baby flow diverter in order to continue to assess clinical safety and performance of the device for treating intracranial aneurysms. The study is designed to collect data for up to five years, with the primary endpoint assessed at one year.
This international and multi-center study involves 29 sites worldwide: France, Germany, Austria, Belgium, 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 Dr. Mario Galdamez, the Principal Investigator for the study. "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 enrollment 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 Chief Executive Officer 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."
About Balt
Since it was established in 1977, Balt has worked with interventional physicians to develop devices to treat complex life-threatening neurovascular conditions such as ischemic strokes, aneurysms, and arteriovenous malformations. A pioneer in the neurovascular field, Balt designs, manufactures, and distributes the broadest portfolio of products in the neurovascular space and is focused on expanding its geographic reach. For more information, please visit: https://www.balt-corp.com/
The Silk Visa and the Silk Vista Baby are not available for sale in the US.
Investor Contact:
Greg Chodaczek
347-620-710
ir@baltgroup.com