Balt has received CE mark approval for its Silk Vista flow diverting stent to treat patients with unruptured intracranial aneurysms, in turn enabling commercialisation 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. According to the news release, 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 flow diverter device for the treatment of distal aneurysms with the benefits of excellent visibility and device deployment,” said Vitor Mendes Pereira, 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 3.5mm and larger, while managing to keep the device compatible with a very low profile .021” microcatheter.” Pereira performed the first-in-man case of Silk Vista in Toronto in June.
The press release also states, that 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 aneurysms.