IRVINE, Calif., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Balt announced today it has enrolled the first patients in North America in the premarket approval (PMA) clinical trial, PIONEER (PIvotal Study Of the Silk Vista Baby Flow Diverters iN the TrEatmEnt of Unruptured Intracranial AneuRysms). Pioneer is the first prospective trial exclusively assessing the role of flow diversion in the treatment of aneurysms in distal small arteries in the brain. This landmark trial is actively enrolling at hospitals in both the U.S. and Canada and is the U.S. approval study for the Silk Vista Baby flow diverter.
Co-Primary Investigator, Vitor Mendes-Pereira, M.D., MSc (St. Michael's Hospital, Toronto, Canada) stated, "The Silk Vista Baby has been a paradigm shift in the care of neurovascular patients. It provides physicians with a significant improvement on access to distal aneurysms with a low profile microcatheter over the treatment options we have available and enables us to provide better care for more patients."
The Silk Vista Baby device was the first flow diverter in the world that delivers through a small 0.017-inch diameter microcatheter. Obtaining European Union regulatory approval in 2018, the device has been used to treat thousands of aneurysm patients around the world and studied extensively in several clinical studies. Patients with distal brain aneurysms often have those aneurysms arise off very small blood vessels and the endovascular treatment options often require access devices that are too big, or the anatomy is not suitable for open surgical solutions.
"The PIONEER study is an important advance for the care of aneurysm patients in the U.S.," said co-Primary Investigator, Ricardo Hanel, M.D., PhD (Baptist Medical Center, Jacksonville, FL), "This study will add tremendously to our knowledge of how to care for patients with distal aneurysms and potentially brings another life-saving tool to the patients of the United States. One that has already changed care for much of the rest of the world."
Balt CEO Pascal Girin commented, "PIONEER marks the second PMA trial for Balt, following the groundbreaking STEM study which resulted in the PMA approval of the SquidTM Liquid Embolic for chronic subdural hematoma patients. We are currently working on multiple additional PMA studies and are committed to continue bringing Balt's innovative solutions to novel indications for physicians and patients around the world."
About Balt:
Since it was established in 1977, Balt has worked with interventional physicians to develop devices to treat complex life-threatening neurovascular diseases such as ischemic strokes, aneurysms and other hemorrhagic conditions including arteriovenous malformations, dural arteriovenous fistulas and chronic subdural hematomas. A pioneer in the neurovascular field, Balt designs, manufactures and distributes the broadest portfolio of products in the neurovascular space and is now focused on expanding its geographic presence in the U.S. Visit Balt at https://www.baltgroup.com/
Contact
Greg Chodaczek
Gilmartin Group
greg@gilmartinir.com
