Endovascular Today

Boston Scientific’s Innova BMS System Approved and Launched in EU

May 14, 2012—Boston Scientific Corporation (Natick, MA) announced that it has received CE Mark approval for the Innova self-expanding bare-metal stent system, which is designed to treat peripheral vascular lesions in arteries above the knee, specifically the superficial femoral artery (SFA) and proximal popliteal artery (PPA). The company will launch the device immediately in Europe and other countries that recognize the CE Mark.

FDA Issues Alert Regarding Endovascular Treatment of CCSVI

May 10, 2012—The US Food and Drug Administration (FDA) issued a press release stating that the agency is alerting health care professionals and patients about injuries and death associated with the use of balloon angioplasty devices or stents to treat chronic cerebrospinal venous insufficiency (CCSVI), which some investigators hypothesize may cause or contribute to the progression of multiple sclerosis (MS) by impairing blood drainage from the brain and upper spinal cord. However, the FDA advised that studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established.

MOBILITY Supports Self-Expanding and Balloon-Expandable Stents for Treating Complex Iliac Disease

May 10, 2012—According to data presented by Michael R. Jaff, DO, at the Society for Cardiovascular Angiography and Interventions (SCAI) 2012 scientific sessions, the MOBILITY study has shown that patients with complex peripheral artery disease lesions who were treated with either a balloon-expandable stent system or a self-expanding stent system experienced improvements in walking ability while maintaining low rates of restenosis and major adverse events.

Medtronic to Launch Valiant Captivia Thoracic Stent Graft in United States, Japan, and China

May 8, 2012—Medtronic, Inc. (Minneapolis, MN) announced that it is expanding availability of the Valiant Captivia thoracic stent graft system in several countries, including China, Japan and the United States.

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