06
Sep
11

Measuring Unruptured Aneurysms

This novel study established a new standard for the measurement of aneurysm treatment success, target aneurysm recurrence rate, and proves that coiling in an excellent treatment for ruptured and unruptured aneurysms.

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.

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.

Matrix Coils employ a proprietary outer copolymer coil over an inner platinum main coil. The copolymer runs the entire length of the main coil and constitutes approximately 70% of total coil volume.

“While the neurovascular specialty commonly measures aneurysm treatment success with angiographic images, we believe success should be more closely aligned with patients’ clinical outcomes,” Mark Paul, president of Stryker Neurovascular, was quoted as saying. “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%).

SOURCE: Society of NeuroInterventional Surgery (SNIS) 8th Annual Meeting in Colorado Springs

 

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