Balt’s Silk Vista Low-Profile Flow Diverters Evaluated in International FIRST Study

July 28, 2021—Balt, a neurovascular company focused on treatments for complex stroke, aneurysms, and arteriovenous malformations, announced completion of enrollment in the FIRST study of the company’s Silk Vista and Silk Vista Baby flow diverters.

The study enrolled 234 patients at 29 sites in France, Germany, Austria, Belgium, Netherlands, Spain, Italy, Croatia, and Israel.

According to the company, the FIRST study is an observational, prospective, multicenter, international, single-arm study with the aim of collecting safety and efficacy information for continued assessment of the performance of the Silk Vista and Silk Vista Baby for treating intracranial aneurysms in a wide range of anatomic locations. The study is designed to collect data for up to 5 years, with the primary endpoint assessed at 1 year.

Mario Galdamez, MD, is Principal Investigator for the FIRST study.

“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,” commented Dr. Galdamez in the company’s press release. “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.”

In July 2020, Balt announced European CE Mark approval for its Silk Vista flow diverting stent to treat patients with unruptured intracranial aneurysms. The lower-profile Silk Vista Baby flow diverter received CE Mark in 2018. The Silk Visa and the Silk Vista Baby are not available for sale in the United States, advised the company.