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Terumo Receives FDA Go-Ahead To Start Trial As Part Of U.S./Japan Pilot

This article was originally published in The Gray Sheet

Executive Summary

Japanese device maker Terumo on May 12 announced it had received conditional FDA approval to begin enrollment for a U.S. clinical trial of its Misago superficial femoral artery stent

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Research In Brief

Euro carotid trials unite: Carotid stenting should be avoided in patients 70 years and older, but could be as safe as surgery in younger individuals, researchers concluded from a 3,433-patient meta-analysis posted online in The Lancet Sept. 9. Combining intent-to-treat analysis data from their three large European randomized trials (EVA-3S, SPACE and ICSS), the team found stroke or death was 53% more likely in subjects in the stent arms than in patients in the surgical study arms 120 days following randomization. But in the younger population, the 120-day stroke or death rate was similar in both groups. The trials included patients with symptomatic carotid artery disease who were at an average risk for undergoing open surgery. The primary meta-analysis did not include data from the 2,502-patient U.S. CREST trial, reported in February, which found overall parity between stenting and surgery in both symptomatic and asymptomatic patients on an endpoint of stroke, heart attack or death, with somewhat better results for stents in the under-70 participants and an advantage for surgery in the over-70 group (1"The Gray Sheet" March 8, 2010). The Lancet study researchers said that a supplementary analysis including the symptomatic CREST patients (about half of those enrolled in that trial), the three meta-analysis studies and five other trials did not alter their conclusion that surgery was generally safer, but that stenting can be considered for younger patients. Carotid stenting in patients who are candidates for surgery is mostly restricted in the U.S. by Medicare coverage policies, but interventionalists have signaled plans to request a major coverage expansion based on CREST and upcoming specialty society guidelines that they say will be heavily influenced by CREST (2"The Gray Sheet" May 31, 2010)

Research In Brief

Euro carotid trials unite: Carotid stenting should be avoided in patients 70 years and older, but could be as safe as surgery in younger individuals, researchers concluded from a 3,433-patient meta-analysis posted online in The Lancet Sept. 9. Combining intent-to-treat analysis data from their three large European randomized trials (EVA-3S, SPACE and ICSS), the team found stroke or death was 53% more likely in subjects in the stent arms than in patients in the surgical study arms 120 days following randomization. But in the younger population, the 120-day stroke or death rate was similar in both groups. The trials included patients with symptomatic carotid artery disease who were at an average risk for undergoing open surgery. The primary meta-analysis did not include data from the 2,502-patient U.S. CREST trial, reported in February, which found overall parity between stenting and surgery in both symptomatic and asymptomatic patients on an endpoint of stroke, heart attack or death, with somewhat better results for stents in the under-70 participants and an advantage for surgery in the over-70 group (1"The Gray Sheet" March 8, 2010). The Lancet study researchers said that a supplementary analysis including the symptomatic CREST patients (about half of those enrolled in that trial), the three meta-analysis studies and five other trials did not alter their conclusion that surgery was generally safer, but that stenting can be considered for younger patients. Carotid stenting in patients who are candidates for surgery is mostly restricted in the U.S. by Medicare coverage policies, but interventionalists have signaled plans to request a major coverage expansion based on CREST and upcoming specialty society guidelines that they say will be heavily influenced by CREST (2"The Gray Sheet" May 31, 2010)

U.S., Japan Regulators Begin Collaborative Review Pilot With Femoral Stents

FDA and Japanese regulators recently began to work together to review two devices - one U.S.-manufactured, one Japanese-made - that are part of a new pilot program intended to model how products can achieve faster market entry in both countries

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