Indicated for improving luminal diameter in patients with iliac atherosclerotic lesions in vessel reference diameters between 4.3 and 9.5 mm and lesion lengths up to 105 mm. A stent designed for iliac artery lesions which are often calcified and occluded. Both the stent and radiopaque markers are completely coated with proBIO. Unique “S-articulations” intend to facilitate stent conformability which allows the stent to track vessel movement while maintaining required chronic outward force.
- Pull-back delivery system enables simple stent deployment
- 5.2 F proximal shaft for contrast injection while device in sheath
- Segmented stent design and strut thickness designed for to provide sufficient chronic outward force in the iliac territory
- S-articulating connecting bars enable peak-to-valley design for multi-directional flexibility
Relieves friction of introducer valve on the retractable shaft during stent deployment, providing a smoother stent release.
Segmented Stent Design for Iliac Artery
- Peak-to-valley design and S-articulating connecting bars provide multi-directional flexibility and avoid fish-scaling in tortuous arteries.
- Segmented design and strut thickness designed to provide sufficient chronic outward force.
Four gold markers at each end of the stent enhance visibility.
Pull-Back Delivery System
Enables simple stent deployement.
Designed to prevent accidental stent deployment.
proBIO reduces ion release
- proBIO reduces release of Nickel and other metal ions from the stent.
- proBIO acts as an effective and reliable barrier to Nickel and other heavy metal ion diffusion.
6 F Introducer Compatibility
6F distal shaft with 5.2F proximal shaft allows contrast injection while the device is positioned inside the introducer and across the lesion.
- Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents.
- The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK Astron and Pulsar stents.
- The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.
- Estimated enrollment: 456
- A Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe.
- BIOFLEX-I EU is the European arm of the BIOFLEX-I IDE study (NCT01319812).
- Data from BIOFLEX-I EU will be pooled with data in the IDE.
- The objective of this study is to separately demonstrate the clinical performance of BIOTRONIK's Astron and Pulsar-18 stents in the European arm of the BIOFLEX-I IDE (NCT01319812).
- The Pulsar-18 stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions. Estimated enrollment: 456
- A Trial Investigating the Safety of 4 F Endovascular Treatment of Infra-Inguinal Arterial Stenotic Disease.
- The objective of this clinical investigation is to evaluate the puncture site complication rate as well as the short- and long-term (up to 24 months) treatment outcomes by means of Astron Pulsar/Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions, using BIOTRONIK 4 F compatible devices and without the use of a closure device.
- The hypothesis is that the primary patency at 12 months is non-inferior to the primary patency obtained in the Durability study (72.2%).
- Enrollment: 120
|Recommended guide wire
||225 μm (ø 10 mm = 230 μm)
||proBIO (amorphous silicone carbide)
|| 4 gold markers each end
||ø 7 - 10 mm; L: 30 - 80 mm
||5.2 F, hydrophobic coating
||70 and 120 cm
1 Nickel release test results, BIOTRONIK data on file.