Stryker’s MAPS Trial Reaches Clinical Endpoint

Stryker Neurovascular, a division of Stryker Corporation, announced the results of its Matrix and Platinum Science (MAPS) Trial during the Society of NeuroInterventional Surgery (SNIS) 8th Annual Meeting in Colorado Springs, Colo.

“While the neurovascular specialty commonly measures aneurysm treatment success with angiographic images, we believe success should be more closely aligned with patients’ clinical outcomes,” said Mark Paul, president of Stryker Neurovascular. “The MAPS Trial demonstrates the validity of TAR [Target Aneurysm Rate] as a clinical endpoint and proves aneurysm coiling is a very effective therapy with excellent clinical outcomes.”

In the trial, 96 percent of patients with unruptured aneurysms and 90 percent of patients with acutely ruptured aneurysms were alive and free of disability up to 15 months after treatment. Overall, Matrix Detachable Coils were found to be as effective as GDC Detachable Coils, which were the first coils cleared by the FDA for the minimally invasive treatment of brain aneurysms. (TAR rates of 13.3 percent vs. 14.6 percent, respectively). Matrix Detachable Coils utilize a PGLA [Polymer Polyglycolic-Lactic Acid] polymer on the outside of a traditional platinum coil that is designed to degrade over time and promote rapid tissue development within the aneurysm.

Matrix Detachable Coils showed a statistically significant, superior long-term TAR rate of 2.7 percent compared to GDC Detachable Coils (9.6 percent) in aneurysms with good occlusion (minimal blood flow entering the aneurysm) immediately after the procedure.

“The MAPS trial shows that the field of neurointervention is now mature enough to successfully carry out a randomized, prospective trial that is rigorously overseen, assesses the performance of contemporary technology and is applicable worldwide,” said Cameron McDougall, M.D., president of SNIS. “In addition, the trial’s clinical endpoint has been demonstrated to be clinically relevant and correlate with immediate post-treatment angiogram, making it reliable and easily adopted by future studies to ensure a consistent measure of treatment success.”

The MAPS trial began in 2007 and includes 626 patients worldwide with a single aneurysm (4-20mm), making the largest, most rigorous randomized controlled study on the clinical effectiveness of coils for treating both ruptured and unruptured aneurysms. The study was designed and led by principal investigators S. Claiborne Johnston, M.D., Ph.D., director of stroke service at the University of California in San Francisco, Cameron McDougall, M.D., who is also chief of Endovascular Neurosurgery, Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center in Phoenix, Ariz., and Anil Gholkar, O.B.E., M.B.B.S., clinical director and consultant neuroradiologist at the Newcastle Upon Tyne Hospital in England, United Kingdom.

“Stryker is very encouraged by the results of the MAPS Trial, and we believe that it has the potential to influence the design of future studies and spur the advancement of new, innovative technologies that can enhance the clinical outcomes of patients with aneurysms in the future,” Paul said.