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Peripheral Angioplasty
Combination therapy for endovascular procedures
Leave almost nothing behind by using Aperta NSE™ PTA scoring balloon catheter for lesion preparation in combination with SeQuent® Please OTW for drug delivery in patients with peripheral artery disease.
Aperta NSE™ PTA
PTA High Pressure Scoring Balloon Catheter
Aperta NSE™ PTA addresses the clinical needs of peripheral artery disease associated with higher rates of uncontrolled dissections, and inadequate luminal expansion. Through an innovative designed catheter, that concentrates the dilative force along four integrated scoring elements, a more predictable luminal expansion and lower rate of uncontrolled dissections can be achieved.
Scoring performance in calcified lesions
Low entry profile and flexible round tip
- Minimizing the tip profile reduces the gap with the wire and provides for better lesion penetration [1]
4 triangular shaped integrated elements
- 0.0155" (0.39 mm) in height, positioned 90° apart
- Stabilize the balloon in the lesion during inflation [1]
- Provide an efficacious scoring effect due to high concentrated force transmission [2]
High pressure scoring balloon
- Low-compliant balloon platform
- RBP is set at 20 atm (ø 4 to 6 mm)
SeQuent® Please OTW
Peripheral Drug-Coated Balloon Catheter
SeQuent® Please OTW features an optimised drug-coating technology which facilitates the safe and effective treatment of patients with peripheral arterial disease.
Long-term efficacy with short-term drug release [3,4]
- Paclitaxel with an effective drug dose of 3μg/mm² [5,6]
- Significant reduction of TLR and in late lumen loss (LLL) compared to uncoated balloons [3,4,7]
Resveratrol: A naturally occurring matrix builder
- Acts as matrix builder and makes the Paclitaxel bioavailable [7]
- Enables fast and effective drug transfer into vessel wall [7]
Mechanically resistant coating [7]
- Homogeneous coating even in the balloon folds exceeding distal and proximal markers [7]
- Low drug loss in simulated use [7]
CONSEQUENT RCT and Registry
Clinical Evidence
SeQuent® Please OTW demonstrated safety and efficacy in the CONSEQUENT randomized controlled trial (N=153) and CONSEQUENT all-comers registry (N= 784 patients) [3,4,6].
References
- Data on file at GOODMAN Co. Ltd.
- Ashida K et al. J Invasive Cardiol. 2013 Oct;25(10):555-64. PMID: 24088433.
- Albrecht T et al. Cardiovasc Intervent Radiol. 2018 Jul;41(7):1008-14.
- Langhoff R et al. Angiology. 2021 Mar 29:3319721997314.
- Tepe G et al. N Engl J Med. 2008 Feb 14;358(7):689-99.
- Tepe G et al. Cardiovasc Intervent Radiol. 2017 Oct;40(10):1535-44.
- Data on file at B. Braun.