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Spine Solutions Single-Level ProDisc Trial Enrollment To Wrap Up By Year-End

This article was originally published in The Gray Sheet

Executive Summary

Spine Solutions is aiming to launch its ProDisc lumbar spine artificial disc in the U.S. by 2005 as an alternative to spinal fusion devices in treating degenerative disc disease

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Research News In Brief

ASA presents Wingspan results: Preliminary results from a registry of Boston Scientific's Wingspan intracranial sent show a 30-day stroke rate of 8.4%, researchers said at the American Stroke Association meeting Feb. 8 in San Francisco. The 30-day stroke rate was 9% in Wingspan's pivotal trial. The National Institutes of Health-sponsored registry has so far collected data from only 131 patients, so the findings must be interpreted "cautiously," said Osama Zaidat, M.D., Medical College of Wisconsin, Milwaukee, Wis., at the meeting. Wingspan is the only FDA-approved intracranial stent, gaining approval under the Humanitarian Device Exemption in August 2005. The rate of ischemic stroke alone within 30 days of treatment (including 24 hour events) was 3.8%....And Chinese intracranial stent study: Another study presented at the ASA meeting suggests intracranial stenting is best reserved for major lesions. Wei-Jian Jiang, M.D., Tiantan Hospital, Beijing, et al. report outcomes of 213 patients with at least 50% stenosis of a major intracranial artery in the Feb. 5 Neurology. Those with "severe" stenosis (more than 70%) had a 30-day ischemic stroke rate of 4.8%, while those with "moderate" stenosis (50%-69%) had a 4.3% stroke rate. The probability of lesion-related stroke and symptomatic brain or subarachnoid hemorrhage at one year was 7.2% for the severe group and 5.3% for the moderate group. "Our results suggest that patients with severe stenosis seem to receive the benefit from elective stenting, whereas patients with moderate stenosis may not," Jiang et al. write...

Research News In Brief

ASA presents Wingspan results: Preliminary results from a registry of Boston Scientific's Wingspan intracranial sent show a 30-day stroke rate of 8.4%, researchers said at the American Stroke Association meeting Feb. 8 in San Francisco. The 30-day stroke rate was 9% in Wingspan's pivotal trial. The National Institutes of Health-sponsored registry has so far collected data from only 131 patients, so the findings must be interpreted "cautiously," said Osama Zaidat, M.D., Medical College of Wisconsin, Milwaukee, Wis., at the meeting. Wingspan is the only FDA-approved intracranial stent, gaining approval under the Humanitarian Device Exemption in August 2005. The rate of ischemic stroke alone within 30 days of treatment (including 24 hour events) was 3.8%....And Chinese intracranial stent study: Another study presented at the ASA meeting suggests intracranial stenting is best reserved for major lesions. Wei-Jian Jiang, M.D., Tiantan Hospital, Beijing, et al. report outcomes of 213 patients with at least 50% stenosis of a major intracranial artery in the Feb. 5 Neurology. Those with "severe" stenosis (more than 70%) had a 30-day ischemic stroke rate of 4.8%, while those with "moderate" stenosis (50%-69%) had a 4.3% stroke rate. The probability of lesion-related stroke and symptomatic brain or subarachnoid hemorrhage at one year was 7.2% for the severe group and 5.3% for the moderate group. "Our results suggest that patients with severe stenosis seem to receive the benefit from elective stenting, whereas patients with moderate stenosis may not," Jiang et al. write...

Synthes-Stratec Finds Spine Solutions To Access Artificial Disc Market

Synthes-Stratec's purchase of Spine Solutions provides access to a total artificial disc market projected to grow to $3 bil. by 2008

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