BioMimics 3D - Vascular Stent System
The Challenge: Peripheral Arterial Disease. People are living longer and with an increase in the incidence of obesity, diabetes and other contributing factors, claudication may cause substantial tissue changes and, in some scenarios, can lead to amputation and even death. The peripheral stent market is forecast to grow to $2 billion by 2024 driven by technological advances, an ageing population and an increase in co-morbidities.
The Approach: Alternative Technologies
Because the superficial femoral artery is a long, relatively straight vessel, it is exposed to low wall shear stress under resting conditions, predisposing it to atherosclerotic disease and confounding the healing process after endovascular injury. Straight stents further straighten the vessel and disturb blood flow, creating areas of low wall shear stress.
Drug coated balloons and drug eluting stents utilising Paclitaxel in the femoropopliteal segment have shown encouraging clinical results but recent publications on the safety of Paclitaxel has put their use under the spotlight and regulatory bodies around the world are advocating caution in their use.
The Solution: The BioMimics 3D Vascular Stent System
Veryan has developed innovative technology to improve the performance of vascular stents by adopting the principle of biomimicry; developing structures that imitate those occurring naturally.
The BioMimics 3D Vascular Stent System is a peripheral self-expanding stent with a unique 3D helical geometry which imparts a gentle helical shape to the stented artery.
- Provoking a swirling flow-mediated increase in wall shear stress that has been shown to reduce intimal hyperplasia.2
- Improves biomechanical compatibility to reduce vascular irritation and injury.
- Reduces the risk of stent fracture.
Swirling flow: nature’s way of protecting patency, engineered by Veryan to improve stenting outcomes as demonstrated in the MIMICS clinical programme.
- Zeller T. Oral Presentation VIVA 2014;
- Caro et al. 2013 J R Soc Interface 10: 20130578
- Data on file at Veryan Medical
The BioMimics 3D Vascular Stent System has a unique 3D helical geometry which imparts a gentle helical shape to the stented artery:1
- Provoking a swirling flow-mediated increase in wall shear stress that has been shown to reduce intimal hyperplasia.2
- Improves biomechanical compatibility to reduce vascular irritation and injury
- Reduces the risk of stent fracture
Swirling Flow
Nature’s way of protecting patency, engineered by Veryan to improve stenting outcomes as demonstrated in the MIMICS clinical programme.3
Improved Biomechanical Performance
The BioMimics 3D Vascular Stent System design enables the stented femoropopliteal vessel to shorten more naturally under the compressive load applied during knee and hip flexion, reducing stent fracture risk and vessel damage both within the stented segment and distal to it.
Excellent Fracture Resistance
The unique helical shape of the BioMimics 3D Vascular Stent System confers important mechanical performance and biomechanical compatibility advantages over straight nitinol stents.
Due to the helical shape of the BioMimics 3D Vascular Stent System it is able to accommodate femoropopliteal arterial shortening during knee bending by distributing the compressive strain across the entire stent. By comparison, the compressive strain in a straight stent becomes localised increasing the risk of fracture.
The BioMimics 3D Vascular Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in native superficial femoral and/or proximal popliteal arteries with reference vessel diameters ranging from 3.5 mm – 7.0 mm.
Features
- A peripheral self-expanding stent with a unique 3D helical centreline
- Laser cut from a straight nitinol tube, the 3D helical shape is stored in the nitinol shape memory
- Three tantalum radiopaque markers are located at each end of the stent to aid placement
Benefits
- Unique 3D stent shape generates swirling flow raising wall shear stress (WSS) to reduce intimal hyperplasia
- Improved biomechanical performance
- Excellent fracture resistance
- Significantly better performance than a straight stent control in a randomised fempop study
BioMimics 3D Delivery System
- Catheter Design : Over-the-wire
- Working Length : 113cm
- Shaft Profile : 6Fr / 2mm
- Sheath compatibility : 6Fr* (minimum iD of 2.2mm)
- Radiopaque markers
- Radiopaque atraumatic system tip
- Distal tip outer sheath
- Tantalum proximal system marker
- Guidewire compatibility : 0.035"
BioMimics 3D® Stent
- Stent material : Nickel-titanium alloy: nitinol
- Radiopaque markers number and location : 3 distal and 3 proximal
- Radiopacity : Excellent1
- Fracture resistance : Excellent1
- MRI compatibility : MRI conditional