Balt announced today it has received CE Mark Approval for its Silk Vista flow diverter stent to treat patients with unruptured intracranial aneurysms, enabling commercialization in over 30 countries in and around the European Union.
Flow diverters are intended to divert blood flow away from an aneurysm, allowing the aneurysm to heal and reducing the risk of aneurysm rupture. The Silk Vista device is designed for predictable and accurate deployment, as well as high visibility under angiography. It joins the lower profile Silk Vista baby flow diverter, which received CE Mark in 2018.
“Balt introduced the Silk Vista baby two years ago, a first-in-class flow diverter device for the treatment of distal aneurysms with the benefits of excellent visibility and device deployment,” said Vitor Mendes Pereira, M.D., an Endovascular Neurosurgeon and Professor of Medical Imaging and Surgery at the University of Toronto. “Now, with Silk Vista, Balt has provided physicians the same outstanding deliverability and visibility for the treatment of aneurysms arising off of neurovascular vessels 3.5 mm and larger, while managing to keep the device compatible with a very low profile .021” microcatheter.” Dr. Mendes Pereira performed the First-in-Man case of Silk Vista in Toronto in June.
Balt CEO Pascal Girin commented, “Balt has provided physicians for decades with unique, life-saving products to treat patients with neurovascular conditions and has been a pioneer in flow diversion technologies. The Silk Vista is an exceptional flow diverter, and we believe its elegant design and ease-of-use will lead to its rapid clinical adoption in treating aneurysms.”
According to the Brain Aneurysm Foundation, ruptured brain aneurysms are fatal in about 50% of cases. Of those who survive, about 66% suffer some permanent neurological deficit. There are almost 500,000 deaths worldwide each year caused by ruptured brain aneurysms1.