Shaping the future with the swirling flow stent

Transcription

1 NEW SIZES AVAILABLE the swirling flow THE SWIRLING FLOW STENT Significantly better performance than straight control s* in a randomised fempop study ¹ GET WITH THE FLOW

2 the swirling flow IMPROVED BIOMECHANICAL PERFORMANCE⁹ Allows shortening during leg flexion and reduces distal kink risk Impact of straight on femoropopliteal artery SWIRLING FLOW Unique 3D architecture generates swirling flow, raising wall shear to limit intimal hyperplasia2 3D technology proven in a pre-clinical model - 4% reduction in neointimal thickness at 30 days (P < 0.001) risk of vessel kinking risk of vessel kinking and vessel trauma and vessel trauma 3D technology pre-clinical model: 30-day histology 3 BioMimics 3D Computational Fluid Dynamic model of swirling laminar flow within a 3D 4 reduced risk of reduced risk of vessel kinking vessel kinking Impact of BioMimics 3D on femoropopliteal artery Straight Stent Straight Stent technology pre-clinical model: 30-day histology 3 G E T W I T H T H E F LO W Computational Fluid Dynamic model of straight laminar flow within a straight 4 PAM 0 Issue 02

3 EXCELLENT FRACTURE RESISTANCE 0% fracture in the Mimics randomised clinical study 1 Straight resists compression, risking damage to and vessel As leg bends, native femoropopliteal artery shortens under axial compression Unique 3D design accommodates shortening and stress is distributed across entire, reducing risk of fracture and associated vascular injury

4 IMPROVED BIOMECHANICAL PERFORMANCE9 Allows shortening during leg flexion and reduces distal kink risk Impact of straight on femoropopliteal artery risk of vessel kinking and vessel trauma reduced risk of vessel reduced kinking risk of vessel kinking Impact of BioMimics 3D on femoropopliteal artery PAM 0 Issue 02

5 EW S L N ZE AB SI IL A AV Significantly better patency through 24 months versus straight control s* No reintervention in the BioMimics 3D arm between 12 and 24 months 0% fracture at 24 months E SIGNIFICANTLY BETTER PERFORMANCE IN A RANDOMISED FEMPOP STUDY 1 the swirling flow P = 0.0 the swirling flow PATENCY Kaplan Meier Survival Estimate of Freedom from Loss of Patency Recommended guidewire F introducer compatible / minimum ID 2.2 mm Delivery catheter working length: 113cm P = 0.14 P = 0.0 BioMimics 3D primary patency 2% through 24 months Straight control primary patency % through 24 months P = 0.03 P = 0.03 Stent Diameter Reference Vessel Stent Length Sheath Compatibility:** Guidewire Diameter Fr/Minimum ID Compatibility (inch) x x x x x NEW 10 x x x x x NEW 10 x x x x x NEW x NEW x NEW x NEW x NEW THE SWIRLING FLOW STENT Significantly better performance than straight control s* in a randomised fempop study ¹ * Straight control s = 24/2 Bard LifeStent ; 1/2 Terumo Misago ; 1/2 Biotronik Pulsar ** Evaluated with Fr Cordis Brite Tip and Fr Terumo Radifocus Introducer II sheath introducers 1. Zeller T. et al; Circ Cardiovasc Interv. 201;9:e DOI: Zeller T. Oral Presentation VIVA Caro et al J R Soc Interface 10: ,, & 9. Data on file at Veryan Medical. BH Smouse et al, Endovasc. Today, vol 4, no., pp. 0-, 200. Scheinert D et al, J Am Coll Cardiol 200;4:312 doi:10.101/j.jacc BioMimics 3D is a registered trademark of Veryan Medical Ltd. 201 Veryan Medical Ltd For additional information please contact your local representative Not available for sale in the United States GERMANY Phone: All other countries Phone: info@veryanmed.com info@veryanmed.com website: veryanmed.com website: veryanmed.com G E T W I T H T H E F LO W G E T W I T H T H E F LO W 0% fracture in the Mimics randomised clinical study 1 EXCELLENT FRACTURE RESISTANCE PAM Issue 02 Indications, contraindications, warnings and Instructions for Use can be found in the product labelling supplied with each device. All cited trademarks are the property of their respective owners. Straight resists compression, risking damage to and vessel Kaplan Meier Survival Estimate of Freedom from CDTLR 12-Month Landmark Analysis No change in CDTLR for BioMimics 3D between the 12 and 24-month timepoints The 3-fold increase in CDTLR in the straight control arm resulted in a significant difference between the BioMimics 3D and control arms between the 12 and 24-month timepoints P = 0.14 Catalogue Number As leg bends, native femoropopliteal artery shortens under axial compression CDTLR 12 MONTH LANDMARK ANALYSIS Quick Order Reference Unique 3D design accommodates shortening and stress is distributed across entire, reducing risk of fracture and associated vascular injury Significantly better primary patency (PSVR 2.0) through 24 months (P = 0.0) O R D E R I N G I N F O R M AT I O N

6 the swirling flow Fr (2.0 mm) Working Length 113 cm ORDERING INFORMATION Recommended guidewire F introducer compatible / minimum ID 2.2 mm Delivery catheter working length: 113cm Quick Order Catalogue Stent Diameter Reference Vessel Stent Length Sheath Compatibility: ** Guidewire Reference Number Diameter Fr/Minimum ID Compatibility (inch) x x x x x NEW 10 x x x x x NEW 10 x x x x x NEW x NEW x NEW x NEW x NEW * Straight control s = 24/2 Bard LifeStent ; 1/2 Terumo Misago ; 1/2 Biotronik Pulsar ** Evaluated with Fr Cordis Brite Tip and Fr Terumo Radifocus Introducer II sheath introducers 1. Zeller T. et al; Circ Cardiovasc Interv. 201;9:e DOI: Zeller T. Oral Presentation VIVA Caro et al J R Soc Interface 10: ,, & 9. Data on file at Veryan Medical. BH Smouse et al, Endovasc. Today, vol 4, no., pp. 0-, 200. Scheinert D et al, J Am Coll Cardiol 200;4:312 doi:10.101/j.jacc PAM Issue 02 BioMimics 3D is a registered trademark of Veryan Medical Ltd. 201 Veryan Medical Ltd Indications, contraindications, warnings and Instructions for Use can be found in the product labelling supplied with each device. All cited trademarks are the property of their respective owners. For additional information please contact your local representative Not available for sale in the United States GERMANY Phone: info@veryanmed.com website: veryanmed.com All other countries Phone: info@veryanmed.com website: veryanmed.com GET WITH THE FLOW