Clinical Information

Provided by the
Society for Vascular Surgery®

FDA Announcements
FDA Approves First-of-Kind Device to Treat Descending Thoracic Aneurysms
The GORE TAG Endoprosthesis System has been approved to treat thoracic aortic aneurysms.
FDA Public Health Advisory on Crestor (rosuvastatin)
The changes to the label include results from a Phase 4 pharmacokinetic study in Asian-Americans and highlight important information on the safe use of Crestor to reduce the risk for serious muscle toxicity (myopathy/rhabdomyolysis), especially at the highest approved dose of 40 mg.
Market withdrawal of Vioxx (rofecoxib) due to increased risk of cardiovascular events
Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib) from the U.S. and worldwide market.
FDA Approves New Stent System to Help Prevent Stroke
FDA approved the system based on a review of clinical studies of safety and effectiveness conducted by Guidant.
FDA Public Health Advisory for Crestor (rosuvastatin)
Certain patient populations may be at an increased risk for serious muscle toxicity (myopathy) associated with Crestor use, especially at the highest approved dose of 40 mg.  
FDA approves Botox to treat Severe Underarm Sweating
FDA has approved Botulinum Toxin Type A (Botox) to treat severe underarm sweating known as "primary axillary hyperhidrosis" that cannot be managed by topical agents such as prescription antiperspirants
FDA Clears Robotic-Like Device for Heart Surgery
FDA Clears Medicinal Leeches for Marketing
Leeches can help heal skin grafts by removing blood pooled under the graft and restore blood circulation in blocked veins by removing pooled blood.
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