Baystate Health Announces Participation in National Clinical Trial for Advanced Brain Aneurysm Treatment

SPRINGFIELD, Mass. — Baystate Health announced today that it was selected to participate in a groundbreaking national clinical trial for Advanced Brain Aneurysm treatment and has enrolled the country’s first three patients. The study, called PIONEER, is evaluating a next-generation flow-diverting stent (Silk Vista Baby) designed specifically for the treatment of unruptured brain aneurysms located along small blood vessels.

Silk Vista Baby, a device developed by Balt Corporation, is designed for smaller blood vessels (1.5 to 3 mm in diameter), and although this innovative device has been available internationally for several years, it has not yet been widely accessible in the United States. To make this device more broadly available, as required by the FDA, Balt Corporation launched a major clinical study, the PIONEER trial (PIvotal Study Of the Silk Vista Baby Flow Diverters iN the TrEatmEnt of Unruptured Intracranial AneuRysms). This prospective, multicenter, single-arm study includes 35 leading centers in the United States and 5 in Canada, all evaluating the safety and efficacy of the Silk Vista Baby device.

The device went through a prolonged approval process with the Centers for Medicare & Medicaid Services (CMS), and Balt Corporation received full CMS approval. Baystate Health was selected as one of the study sites. “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 Dr. Varun Naragum, Director of the Baystate Neuroendovascular Program. “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 enroll and treat the first three patients in the study within days of receiving approval, a testament to the commitment and expertise of our team.”

Flow diversion is a treatment for brain aneurysms in which a doctor places a flexible mesh tube (stent) inside a main blood vessel. The stent redirects blood flow away from the aneurysm, reducing the risk of rupture. Flow diversion has become the main approach for treating unruptured brain aneurysms. However, currently available flow-diverting stents are only designed for use in larger blood vessels in the brain. As of now, no flow-diverting stent has been approved in the United States for brain aneurysms along small (distal) blood vessels.

Previously, when patients in the U.S. needed treatment and needed to utilize the Silk Vista Baby device, physicians, including those at Baystate Health, had to apply for a humanitarian device exemption (HDE) from the FDA. This process could take up to four to eight weeks, potentially delaying critical care. “Baystate Health has utilized this pathway to treat patients who could not benefit from current FDA-approved devices, underscoring our commitment to providing the most advanced care possible,” said Dr. Naragum.

Participation in this study allows Baystate Health to offer eligible patients access to this advanced treatment for brain aneurysms located along small blood vessels. “The Baystate Neuroendovascular Program is one of the busiest Brain Aneurysm programs in New England, using state-of-the-art technologies to provide the best possible care for brain aneurysm patients,” said Dr. Naragum.

After the study, use of the Silk Vista Baby device will be temporarily restricted to humanitarian device exemption cases, pending full FDA approval.

About Baystate Health
Baystate Health is a not-for-profit, integrated healthcare system with hospitals, physician practices, a health plan and more serving over 800,000 people throughout western New England. Baystate Health is the safety net provider in Western Massachusetts. With roots dating to the founding of Springfield Hospital in 1883, Baystate Health has been providing high-quality, compassionate and accessible care in the Pioneer Valley for more than 140 years and continues to be a pillar of its community – rooted here, serving here, and helping generations thrive here. With a focus on advancing health for all, Baystate is not only a keystone of the region, it is a national leader in healthcare.