Balt Extrusion SAS has received CE mark approval for its Silk Vista flow diverting stent for those with unruptured intracranial aneurysms. Flow diverters aim to divert blood flow away from an aneurysm, allowing it to heal and reducing the risk of rupture.
Citing statistics from the Brain Aneurysm Foundation, Balk said that ruptured brain aneurysms are fatal in about 50% of cases, with roughly 500,000 people dying annually worldwide. In addition, about 66% of survivors suffer some permanent neurological deficit.
"Silk Vista utilizes a smaller profile catheter for delivery and is designed to have excellent visibility under fluoroscopy along with excellent deliverability characteristics,” Mohamed Bahri, director of marketing at Montmorency, France-based Balt, told BioWorld. He also noted that commercial activities will begin in countries that follow the CE mark, and his company intends to start a U.S. clinical trial in the future.
For his part, Balt CEO Pascal Girin heralded the action related to Silk Vista. “[W]e believe its elegant design and ease-of-use will lead to its rapid clinical adoption in treating aneurysms,” Girin concluded.
Building on Silk Vista baby
Bahri also discussed Silk Vista baby, which he noted was the only flow diverter available that delivers through a .017” microcatheter. “As with Silk Vista, it has excellent visibility and delivery characteristics,” he continued. “These benefits have resulted in very strong market adoption.” The company unveiled Silk Vista baby after gaining the CE mark two years ago to help treat distal aneurysms.
“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,” said Vitor Mendes Pereira, an endovascular neurosurgeon and professor of medical imaging and surgery at the University of Toronto. Mendes Pereira performed the first-in-human case of Silk Vista in Toronto last month.
Beyond these flow diverters, the company also has an IDE trial with Squid liquid embolic device for the treatment of chronic subdural hematoma. In May, Balt USA LLC, the company’s Irvine, Calif.-based unit, said it had received a thumbs up from the U.S. FDA to kick off the trial. The nonadhesive agent offers a minimally invasive option for a neurological condition that often requires brain surgery to correct.
The prospective, randomized, controlled, multicenter trial will evaluate the safety and effectiveness of middle meningeal artery embolization using the Squid device for the management of chronic subdural hematoma in both surgical and nonsurgical patients.
Bahri confirmed that the company has worked actively with sites to prepare for initial patient enrollment.
Other flow diverters
The flow diverter area has been hot. For example, earlier this year, Microvention Inc., a subsidiary of Terumo Corp. based in Aliso Viejo, Calif., said it had gained the FDA’s nod for its Flow Redirection Endoluminal Device for the treatment of brain aneurysms. The flow diverter uses a self-expanding, braided nitinol mesh, with an eye toward rerouting blood flow away from the weakened area and promote occlusion.
Meanwhile, in early 2019, Dublin-based Medtronic plc received FDA approval for an expanded indication for its Pipeline Flex embolization device. This expansion provided options for patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery. The device diverts blood flow away from an aneurysm and previously had been indicated for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms.