Combination Therapy For Endovascular Procedures

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Undress the full metal jacket

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

B. Braun Melsungen AG
Sieversufer 8
12359 Berlin
Germany