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Landmark Stryker Trial Establishes Coiling as Safe and Effective Treatment for Ruptured and Unruptured Aneurysms
MAPS Trial Sets New Clinical Standard for Aneurysm Treatment
Begun in 2007, the MAPS trial is the largest, most rigorous randomized controlled study to-date on the clinical effectiveness of coils for treating both ruptured and unruptured aneurysms, which are estimated to affect approximately 5% of the population. Designed and led by Principal Investigators S. Claiborne Johnston, M.D., Ph.D., Cameron McDougall, M.D., and Anil Gholkar, O.B.E., M.B.B.S., the trial examined 626 patients worldwide with a single aneurysm, 4-20mm in size, treated with Matrix2® Detachable Coils or GDC® Detachable Coils.
Implanted in more than 250,000 patients worldwide, GDC Detachable Coils are made of very soft platinum wire and were the first coils cleared by the FDA for the minimally invasive treatment of brain aneurysms in 1995. Cleared in 2002, Matrix2 Detachable Coils incorporate a PGLA polymer on the outside of a traditional platinum coil that is designed to degrade over time and promote rapid tissue development within the aneurysm.
"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 as a clinical endpoint and proves aneurysm coiling is a very effective therapy with excellent clinical outcomes."
In the trial, 96% of patients with unruptured aneurysms and 90% of patients with acutely ruptured aneurysms were alive and free of disability out to 15 months after treatment. Trial results also demonstrate that, overall, Matrix2 Detachable Coils are as effective as GDC Detachable Coils (TAR rates of 13.3% vs. 14.6%, respectively). In aneurysms with good occlusion (minimal blood flow entering the aneurysm) immediately post procedure, Matrix2 Detachable Coils demonstrate a statistically significant, superior long-term TAR rate of 2.7% compared to GDC Detachable Coils (9.6%).
"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., the current president of SNIS. ** "While not comparing clipping to coiling, the trial shows better endovascular results than previous benchmark studies, specifically ISAT and ISUIA***. 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."
"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," Mark Paul continued.
* Target aneurysm rate is defined as aneurysm recurrence evidenced by a clinically relevant event of aneurysm bleeding/rebleeding, aneurysm reintervention or death from an unknown cause.
**Cameron McDougall, M.D., did not have any financial compensation for his participation in the trial nor does he have any financial interest in the products.
**ISAT refers to the International Subarachnoid Aneurysm Trial, and ISUIA refers to the International Study of Unruptured Intracranial Aneurysms.
About the Society of NeuroInterventional Surgery
The Society of NeuroInterventional Surgery (SNIS) is represented by physicians who specialize in minimally invasive techniques to treat neurovascular conditions, including stroke, aneurysms, carotid stenosis and spinal abnormalities. Drawing on diverse backgrounds and expertise including interventional neuroradiology, neurosurgery and neurology, these physicians are continuing to forge new pathways in the development of the distinct specialty of neurointervention. Over the past two decades, practitioners of this field have paved the way for the scientific research and study that has resulted in new technology and revolutionary treatment approaches that have transformed the neurosciences. In keeping with the mission of SNIS, the society remains committed to working in partnership to advance the science and medical environment that will result in enhanced quality of care for patients across the globe.
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