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Supera Peripheral Stent System


Change the Rules Unparalleled levels of both strength and
flexibility, minimizing the traditionally required design
trade-offs. The mimetic design changes the rules fo

The following contents are from Abbott Vascular website.

 

Supera Peripheral Stent System

Indications & Important Safety Information    IFU (Full Version) ››

 
Overview

Change the Rules

 

  • Unparalleled levels of both strength and flexibility, minimizing the traditionally required design trade-offs.
  • The mimetic design changes the rules for vessel preparation and sizing, allowing for unique mechanical benefits in a challenging environment.

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Flexibility is defined as kink resistance. Supera implant demonstrated lowest kink resistance for 5.5 and 6.5 x 100 mm implants as compared to 6 x 100 mm standard nitinol stents in a tube. 20 lbs compression resistance for 5.5 x 100 mm Supera implant to achieve 53% compression. Four times the compression resistance of all other competitors. All other products compressed 53% with less than 5 lbs applied. Supera Peripheral Stent System Instructions for Use. Data on file at Abbott Vascular.

 

 
Features

The Supera Vascular Mimetic Implant:

  • Mimics the natural structure and movement of the anatomy1
  • Maintains a visibly round, open lumen for normal, healthy blood flow in challenging anatomy2
 

Provides unparalleled strength and flexibility3 for a durable solution5

  • 20 pounds of compression resistance with the lowest chronic outward force4
  • Effective choice in challenging clinical scenarios, including long and calcified lesions5

 

Clinically proven

  • 264 patients studied in the SUPERB trial5
  • Over 1,100 real-world patients analyzed worldwide in 7 retrospective analyses6
  • 86.3% patency (K-M) at 1 year for SFA and proximal popliteal5
  • Zero fractures at 1 year across all analyses6
 

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Second image courtesy of Dr. Hans Biemans, Rivas Hospital Gorinchem, the Netherlands.
1. Data on file at Abbott Vascular.
2. Characteristically round lumens supported by Arena, FJ. Intravascular Ultrasound Evaluation of Interwoven Nitinol Stents at Implant. Journal of Vascular Medicine & Surgery, 2013, 1, 3. Data on file at Abbott Vascular.
3. Strength is defined as compression resistance, flexibility is defined as kink resistance measured in a tube. Data on file at Abbott Vascular.
4. 20 lbf compression resistance for 5.5 x 100 mm Supera implant to achieve 53% compression. Four times the compression resistance of all other competitors. All other products compressed 53% with less than 5 lbf applied. Data on file at Abbott Vascular.
5. Supera Peripheral Stent System Instructions for Use
6. 1,152 patients analyzed retrospectively, see Scheinert, et al., Real world perspectives of treating complex SFA-Pop lesions, Results from the SUPERA-500 (including Leipzig SFA, Leipzig Popliteal and S500 LL) Registry, LINC 2013, 495 patients; Goverde, et al., AURORRAregistry: Experience with high radial force interwoven nitinol stents in femoro-popliteal arteries, LINC 2013, 117 patients; Molenaar, et al., Interwoven self-expanding nitinol stents for long complex SFA and popliteal lesions CWZ, LINC 2012, 178 patients; Goltz, et al., Endovascular Treatment of Popliteal Artery Segments P1 and P2 in Patients with Critical Limg Ischemia, J Endovasc Ther 2012;19:450-456, 40 patients; Chan, et al., HK Single-centre Results of Femoro-popliteal Revascularization using Helical Interwoven Nitinol Stents, LINC 2013, 75 patients; Pacanowski, et al., RESTORE: Interwoven Stents in the Real World, The Initial United States Experience with the Use of the Supera Stent in the SFA and Popliteal Artery, LINC 2013, 147 patients; Kovach, R., SAKE, Supera Interwoven Nitinol Stent Outcomes in Above-Knee Interventions: A Single Center Experience, LINC 2013, 100 patients.

 

 
Lesion Preparation

 

Per the Instructions for Use, prepare the vessel utilizing standard angioplasty technique using a balloon size greater than or equal to the stent diameter. (Refer to Lesion Treatment section in the IFU)

 

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