Springfield, Mass. — Baystate Health has been selected to participate in a national clinical trial evaluating a next-generation flow-diverting stent for treating unruptured brain aneurysms in small blood vessels.
Baystate said it is the first hospital in the country to enroll patients in the PIONEER study and has already enrolled the first three participants.
The trial is evaluating Silk Vista Baby, a device developed by Balt Corporation for blood vessels measuring approximately 1.5 to 3 millimeters in diameter. The device has been available internationally but has not yet been broadly available in the United States.
The PIONEER study is a prospective, multicenter, single-arm trial involving 35 centers in the United States and five in Canada. Researchers are evaluating the safety and effectiveness of Silk Vista Baby for treating unruptured intracranial aneurysms.
“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, Director of the Baystate Neuroendovascular Program. “We look forward to evaluating the safety and efficacy of the Silk Vista Baby device.”
Naragum said Baystate enrolled and treated the first three patients within days of receiving approval to participate in the study.
Flow diversion involves placing a flexible mesh stent inside a blood vessel to redirect blood flow away from an aneurysm, reducing pressure on the weakened area and the risk of rupture.
Baystate said currently available flow-diverting stents in the United States are generally designed for larger blood vessels, and no device has been approved specifically for aneurysms located along smaller distal vessels.
Before the trial, physicians seeking to use Silk Vista Baby for certain U.S. patients had to pursue access through a humanitarian device exemption process, which Baystate said could take several weeks.
“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,” Naragum said.
Participation in the PIONEER trial will allow eligible Baystate patients to receive the device as part of the study while researchers assess its safety and efficacy.
“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,” Naragum said.
After the study concludes, use of Silk Vista Baby in the United States will remain limited to humanitarian device exemption cases unless and until the device receives full FDA approval.
