ConSeQuently less metal
Leave almost nothing behind by using our proven SeQuent® Please OTW DCB in combination with VascuFlex® LOC multiple stent systems for spot and focal stenting.
SeQuent® Please OTW: A fruitful formulation
Paclitaxel with a drug dose of 3 μg/mm²
- Proven and effective drug dose [1]
- Homogeneous coating even in the balloon folds [2]
Resveratrol as hydrophilic excipient
- Naturally occurring, plant based substance found e.g. in red grapes & raspberries
- Acts as hydrophilic spacer and makes Paclitaxel bioavailable
- Enables drug transfer into vessel wall [2]
CONSEQUENT randomized controlled trial
- 153 patients (78 DCB vs. 75 POBA)
- Rutherford 2-4 (95 % Grade 3-4)
- Diameter stenosis pre-procedure: 76.6 ± 18.1 %
- TASC C/D lesions: 23.5 %
- Mean lesion length 13.2 ± 10.4 cm
- Positive remodeling (LLL <0.00 mm) in DCB group: 36.5 %
- Predilatation: in only 55.6 % of cases
- Bailout stenting: 16.3 % (similar in both groups)
- Primary endpoint: 6-month angiographic late lumen loss
- Secondary endpoints: TLR, binary restenosis (> 50 %, PSVR > 2.4), walking distance, ABI at 6, 12 and 24 months
VascuFlex® Multi-LOC: Spot your lesions with short stents only!
- Six short stents on one delivery system
- Cover lesions only where it is really needed
- Maintain natural vessel movement
- Avoid full metal jackets
Features
- Short self-expanding Nitinol stents of 13 mm length each
- Stents with high radial force for highly calcified lesions [2]
- 5-8 mm stent diameters for SFA and popliteal arteries
- 0.035” guidewire compatibility; 6F sheath compatibility
LOCOMOTIVE extended study: 12-month data [8]
- 357 patients
- 71.1 % Rutherford stages 3 to 5
- Lesions in SFA and popliteal artery (segments 1 to 3) with vessel diameter: 5.5 ± 1.1mm
- Average lesion lengths: 16.0 ± 9.7 cm
- Calcification: 85.7%
- Chronic total occlusion: 31.4 %
- TASC C&D lesions: 44.5%
- TLR rate at 6 months (primary endpoint): 4.5 % (Revaskularisation rate of the target lesion)
- Secondary endpoints: TLR at 12 months, patency (Duplex ultrasound), Rutherford classification, amputation rate, ABI and walking distance at 6 and 12 months
[1] Katsanos K et al. in J Endovasc Ther. 2016 Apr;23(2):356-70
[2] Data on file at B. Braun
[3] Albrecht T et al. Cardiovasc Intervent Radiol. 2018 Jul;41(7):1008-1014
[4] Schröder H Catheterization and Cardiovascular Interventions, Volume 86, Issue 2 August 2015 Pages 278-286
[5] Werk M et al. Circ Cardiovasc Interv. 2012;5(6):831-840
[6] Scheinert D et al. JACC Cardiovasc Interv. 2014;7(1):10-19
[7] Zeller T et al. JACC Cardiovasc Interv. 2015;8(12):1614-1622
[8] Amendt K, et al. Vasa (2020), 1-8.doi.org/10.1024/0301-1526/a000927
Vascular Systems