Baystate Health (Springfield, USA) has announced it was previously selected to participate in a clinical trial intended to advanced brain aneurysm treatment, and has now enrolled the first three patients in the USA. The PIONEER study is evaluating a next-generation flow-diverting stent—Silk Vista Baby (Balt)—designed specifically for the treatment of unruptured brain aneurysms located along small blood vessels.
Silk Vista Baby is designed for smaller blood vessels of 1.5–3mm in diameter and, although this innovative device has been available internationally for several years, it has not yet become widely accessible in the USA. In an effort to make the device more broadly available, as required by the US Food and Drug Administration (FDA), Balt launched the PIONEER study—a prospective, multicentre, single-arm study including 35 leading centres in the USA and five in Canada, all evaluating the safety and efficacy of Silk Vista Baby.
“Baystate is proud to have been selected as a study site, a reflection of our longstanding expertise in treating brain aneurysms and our record of excellent patient outcomes,” said Varun Naragum (Baystate Health, Springfield, USA). “We look forward to evaluating the safety and efficacy of the Silk Vista Baby device. Thanks to the dedication of our clinical trials unit, we were able to enrol and treat the first three patients in the study within days of receiving approval—a testament to the commitment and expertise of our team.”
A press release from Baystate Health attempts to contextualise the importance of this study, noting that currently available flow-diverting stents are only designed for use in larger blood vessels in the brain. As of now, the release adds, no flow-diverting stent has been approved in the USA for brain aneurysms located along small, more distal blood vessels. Previously, when patients in the USA required treatment utilising the Silk Vista Baby device, physicians had to apply for a humanitarian device exemption (HDE) from the US FDA, a process that could take up to 4–8 weeks and thus potentially delay critical care.
“Baystate Health has utilised this pathway to treat patients who could not benefit from current FDA-approved devices, underscoring our commitment to providing the most advanced care possible,” Naragum added. “The Baystate Neuroendovascular Program is one of the busiest brain aneurysm programmes in New England, using state-of-the-art technologies to provide the best possible care for brain aneurysm patients.”
Following the PIONEER study, use of Silk Vista Baby will be temporarily restricted to HDE cases, pending full US FDA approval of the device.
