Detailed description
Biflex Compression Bandage Kit is designed to provide effective and comfortable2 compression therapy for patients suffering from, venous ulcers, lymphedema and chronic edema.
This kit includes two shortstretch bandages that apply the necessary pressure to reduce swelling and promote healing6,7.
The bandages are soft3, breathable4, and latexfree, ensuring comfort2 even when worn for extended periods.
Each bandage is marked with calibration lines for easy1 and accurate application.
The bands are also washable and reusable, making them an adapted solution for longterm care.
1 Ease of use : Compulce study: Evaluation of the clinical efficacy and safety of the KitBiflex 2layer compression system versus the PROFORE® 4layer compression system in the treatment of leg ulcers of venous origin (stage C6). National, multicenter, randomized, openlabel, two parallelgroup, phase IIIb clinical study. Study : NCT02782689.
2 Comfort : soft, breathable materials, bi-stretch for greater freedom of movement : Compulce study: Evaluation of the clinical efficacy and safety of the KitBiflex 2layer compression system versus the PROFORE® 4layer compression system in the treatment of leg ulcers of venous origin (stage C6). National, multicenter, randomized, openlabel, two parallelgroup, phase IIIb clinical study. Study : NCT02782689.
3 Soft : materials: IFTH study No. DEV004842
4 Breathable : viscose-based (Compulce study: Evaluation of the clinical efficacy and safety of the KitBiflex 2-layer compression system versus the PROFORE® 4-layer compression system in the treatment of leg ulcers of venous origin (stage C6). National, multicenter, randomized, open-label, two parallel-group, phase IIIb clinical study. Study : NCT02782689.)
5 Proven efficacy: Compulce study: Evaluation of the clinical efficacy and safety of the KitBiflex 2-layer compression system compared with the PROFORE® 4-layer compression system in the treatment of venous leg ulcers (stage C6). National, multicentre, randomised, open-label, two parallel-group, phase IIIb clinical trial. Study number: NCT02782689.
6 Rapid ulcer reduction: Compulce 2019: A complete healing rate of 48.9% and 24.4% was reported in the Biflex kit versus PORFORE groups at 16 weeks.
7 Level of pressure sustained over time, including during activity: CER
Patient profile
Innovation
Specifications
Venous ulcer of the lower limb (CEAP classification stage C6).
Chronic venous oedema.
Lymphoedema.- Arterial pathologies:
peripheral arterial disease (PAD), arterial ulcer or mixed ulcer with a predominantly arterial component (ankle-brachial index: ABI < 0.6 (according to the French Health Authority) or > 1.3). - Patients suffering from advanced diabetic microangiopathy, phlegmasia cerulea dolens with arterial compression, or septic thrombosis.
- Extra-anatomic bypass.
- Uncontrolled heart failure.
- Pre-existing or infected dermatological conditions (abscesses, boils, infected dermatitis).
- Known allergy to one of the components.
- Advanced peripheral neuropathy.
- Uncontrolled diabetes. Specifically when worn on an upper limb:
- Brachial plexus pathology.
- Vasculitis of the extremities.
- Arterial pathologies:
Size Ankle circumference Size 1 0 cm - 25 cm Size 2 25 cm - 30 cm Size 3 30 cm - 100 cm bandage 1: polyester microfibre + viscose + elastane + polyamide
bandage 2: viscose polyester polyamide elastaneThe medical device class I, mentioned on this document is CE marked according to the European Regulation 2017/745 on medical devices.
Please read carefully the instructions for use of the product.
The version of the manual available online is the current version.
Depending on the date of manufacture and place of purchase of the product, this original version of the manual may differ from the version physically present with the product.
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