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Abbott announced on August 7 that the U.S. Food and Drug Administration (FDA) approved the Omnilink Elite® Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease, The FDA approval was based on positive clinical data from the MOBILITY (Omnilink Elite or Absolute Pro® Stent Used in the Iliac Artery) study.
The Omnilink Elite stent is based on the Multi-Link stent design with a cobalt chromium alloy. According to Abbott, cobalt chromium is stronger and more radiopaque than stainless steel, making the stent easy to see under X-ray while maintaining thin, flexible struts. These features are designed to enable the easier navigation of the stent in complex anatomy and to facilitate accurate placement of the device.
"At nine months, patients experienced significant improvements in walking distance and speed, and were able to climb more stairs than they could before treatment,\" said Dr. Tony S. Das, director, Peripheral Vascular Interventions, Presbyterian Heart Institute in Dallas, Texas, and co-principal investigator of the MOBILITY study.
The MOBILITY study was a prospective, non-randomized, two-arm, multi-center study conducted at 48 centers in the United States to evaluate the effectiveness of two Abbott stents – Absolute Pro Vascular Self-Expanding Stent System and Omnilink Elite Vascular Balloon-Expandable Stent System – in patients who had iliac artery disease with intermittent claudication or critical limb ischemia, including complex lesions. The study did not exclude patients with highly calcified lesions or severe peripheral vascular disease. Of the 304 patients enrolled in the study, 151 were treated with Absolute Pro and 153 were treated with Omnilink Elite.
The study met its primary endpoint: a nine-month major adverse event rate of 6.1 percent for patients treated with Absolute Pro and 5.4 percent for patients treated with Omnilink Elite. Walking ability significantly improved for patients in both arms of the study, according to the press release from Abbot.
Abbott announced on August 7 that the U.S. Food and Drug Administration (FDA) approved the Omnilink Elite® Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease, The FDA approval was based on positive clinical data from the MOBILITY (Omnilink Elite or Absolute Pro® Stent Used in the Iliac Artery) study.
The Omnilink Elite stent is based on the Multi-Link stent design with a cobalt chromium alloy. According to Abbott, cobalt chromium is stronger and more radiopaque than stainless steel, making the stent easy to see under X-ray while maintaining thin, flexible struts. These features are designed to enable the easier navigation of the stent in complex anatomy and to facilitate accurate placement of the device.
"At nine months, patients experienced significant improvements in walking distance and speed, and were able to climb more stairs than they could before treatment,\" said Dr. Tony S. Das, director, Peripheral Vascular Interventions, Presbyterian Heart Institute in Dallas, Texas, and co-principal investigator of the MOBILITY study.
The MOBILITY study was a prospective, non-randomized, two-arm, multi-center study conducted at 48 centers in the United States to evaluate the effectiveness of two Abbott stents – Absolute Pro Vascular Self-Expanding Stent System and Omnilink Elite Vascular Balloon-Expandable Stent System – in patients who had iliac artery disease with intermittent claudication or critical limb ischemia, including complex lesions. The study did not exclude patients with highly calcified lesions or severe peripheral vascular disease. Of the 304 patients enrolled in the study, 151 were treated with Absolute Pro and 153 were treated with Omnilink Elite.
The study met its primary endpoint: a nine-month major adverse event rate of 6.1 percent for patients treated with Absolute Pro and 5.4 percent for patients treated with Omnilink Elite. Walking ability significantly improved for patients in both arms of the study, according to the press release from Abbot.
Abbott announced on August 7 that the U.S. Food and Drug Administration (FDA) approved the Omnilink Elite® Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease, The FDA approval was based on positive clinical data from the MOBILITY (Omnilink Elite or Absolute Pro® Stent Used in the Iliac Artery) study.
The Omnilink Elite stent is based on the Multi-Link stent design with a cobalt chromium alloy. According to Abbott, cobalt chromium is stronger and more radiopaque than stainless steel, making the stent easy to see under X-ray while maintaining thin, flexible struts. These features are designed to enable the easier navigation of the stent in complex anatomy and to facilitate accurate placement of the device.
"At nine months, patients experienced significant improvements in walking distance and speed, and were able to climb more stairs than they could before treatment,\" said Dr. Tony S. Das, director, Peripheral Vascular Interventions, Presbyterian Heart Institute in Dallas, Texas, and co-principal investigator of the MOBILITY study.
The MOBILITY study was a prospective, non-randomized, two-arm, multi-center study conducted at 48 centers in the United States to evaluate the effectiveness of two Abbott stents – Absolute Pro Vascular Self-Expanding Stent System and Omnilink Elite Vascular Balloon-Expandable Stent System – in patients who had iliac artery disease with intermittent claudication or critical limb ischemia, including complex lesions. The study did not exclude patients with highly calcified lesions or severe peripheral vascular disease. Of the 304 patients enrolled in the study, 151 were treated with Absolute Pro and 153 were treated with Omnilink Elite.
The study met its primary endpoint: a nine-month major adverse event rate of 6.1 percent for patients treated with Absolute Pro and 5.4 percent for patients treated with Omnilink Elite. Walking ability significantly improved for patients in both arms of the study, according to the press release from Abbot.