Abbott has announced receiving FDA clearance for the company’s Omnilink Elite Vascular Balloon-Expandable Stent System, a cobalt chromium alloy stent for treatment of iliac artery disease.
The approval stems from a clinical study comparing Abbott’s Absolute Pro stent to the Omnilink Elite, which resulted in “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.” This was considerably below the study’s endpoint goal of 19.5 percent.
Features from the product page:
6F Sheath Compatible Across All Sizes
- Low profile system leveraging next generation stent and balloon technology
- Excellent balloon rewrap
- Low profile
- Dual-lamen catheter provides strong push
- Dual-layer balloon with excellent stent retention
Flexibility Without Compromising Strength
- Thin CoCr stent struts
- Proven flexible stent design
- High RBP
- No compromise in strength or radiopacity
Product page: Omnilink Elite Peripheral Stent System…