The PIONEER clinical trial evaluates a device designed to treat difficult-to-reach brain aneurysms, potentially expanding treatment options for patients in the U.S.

Jacksonville, Fla., November 13, 2026 – Baptist Health completed its first procedure as part of the PIONEER study, an international clinical trial evaluating a next generation flow-diverting stent designed specifically to treat unruptured brain aneurysms located in small blood vessels and harder-to-reach areas.

A brain aneurysm is a weak, bulging spot in the wall of an artery inside or around the brain that fills with blood. If it ruptures, the bleeding can cause a life-threatening stroke.

The minimally invasive procedure involves implanting a tiny mesh tube, called the Silk Baby Vista Flow Diverter, into blood vessels measuring just 1.5 to 3 mm in diameter, about the thickness of a credit card to two stacked dimes. The device is delivered through a tiny microcatheter, which is what facilitates its use in smaller vessels. Then, the device is implanted in an artery to help redirect blood flow away from the weakened area of the brain and reduce the pressure causing an aneurysm. Over time, the aneurysm can seal off and heal, lowering the risk of a rupture.

Known treatment, new possibility

Flow diversion is a common treatment for many brain aneurysms, but existing devices are designed for larger arteries.

“For years, we’ve had excellent tools to treat brain aneurysms in large vessels, but some aneurysms form in smaller vessel, making them more challenging to treat,” explained Eric Sauvageau, MD, neurosurgeon, co-medical director of the Baptist Stroke & Cerebrovascular Center and investigator in the PIONEER study. “This study is evaluating a technology designed specifically for aneurysms in smaller vessels, with the potential to expand treatment possibilities for patients who may have had limited options in the past.”

Bringing research home

 While the device is available in Europe, it is not yet approved by the Food and Drug Administration (FDA) for widespread use the U.S. The PIONEER study has FDA IDE approval G250235, NCT NCT07225075. Through the PIONEER clinical trial, eligible patients at Baptist Health and other trial sites have access to this technology while researchers evaluate its effectiveness as part of the FDA approval process. Baptist Health is one of only 40 participating sites in the U.S. and five sites in Canada.

“Clinical research allows us to bring emerging innovations to our patients before they become widely available,” said Ricardo A. Hanel, MD, PhD, neurosurgeon, co-medical director of the Baptist Stroke & Cerebrovascular Center and international principal investigator of the study. “Our goal is not only to deliver excellent care today, but to help shape the future of care for patients throughout the U.S. Studies like PIONEER allow us to evaluate emerging technologies, expand access to advanced treatment options and help determine how aneurysm care evolves in the years ahead.”

Physicians providing care at Baptist Health hospitals are not employees or agents of the hospital. Ricardo Hanel, MD, PhD, and Eric Sauvageau, MD, are employed by Lyerly Baptist, Inc.

About Baptist Health

Based in Jacksonville, Florida, Baptist Health is a community-based health system focused on making health care easier to access while working to improve health and well-being. As the area’s only locally governed, faith-based, not-for-profit health system, Baptist Health delivers a full spectrum of preventive and specialty care through its 200+ ambulatory locations, six acute care hospitals, home health and virtual care offerings. Through its comprehensive approach to whole-person health for children and adults, Baptist Health provides the area’s largest network of primary care, urgent care and behavioral health care, as well as many specialty services and several wellness centers. Destination centers of excellence include Baptist MD Anderson Cancer Center, Baptist Heart Hospital, Baptist Neurological Institute, and Wolfson Children’s Hospital, the only full-service children’s hospital serving the region. To help people get the care they need when and where they need it, the health system leverages digital technology to enhance the delivery of its high-quality, seamless, patient-centered care. Baptist Health is vital to the community, caring for more patients in Northeast Florida than any other provider. The health system has been consistently ranked as “most preferred” for more than 30 years and has been named one of “America’s Greatest Workplaces in Health Care” by Newsweek magazine. To learn more, visit BaptistJax.com.