The FDA has issued approval for Boston Scientific‘s Express LD Iliac Premounted Stent System, granting it an indication for the treatment of peripheral artery disease in iliac arteries. It is the same balloon expandable stent that has FDA indication for palliation of malignant neoplasms in the biliary tree, and already has the European CE Mark of approval for PAD in iliac procedures.
From the product page:
The Tandem Architecture™ design is comprised of both Micro™ and Macro™ Elements, which contribute to:
* Flexibility
* Conformability
* Radial Strength
* Radiopacity
Precision
* Customized balloon lengths for each stent size. Designed for minimal foreshortening and accurate placement.
1. Balloon Inflation Lumen
2. Ergonomic Catheter Hub
3. Strain Relief
4. Catheter Shaft
5. Radiopaque Marker Bands
6. Catheter Tip
7. Stent Length
8. Distal Shaft Coated with Hydro Pass® Hydrophilic Coating for Approximately 36cm
9. Total Usable Length
10. 0.035″ (0.89mm) Guidewire Lumen
Press release: FDA Approves Boston Scientific’s Express® LD Iliac Stent System …
Product page: Express® LD Iliac Premounted Stent System…