FlowLine Bipore®

1. Product Overview

The FlowLine Bipore® is a high-performance vascular prosthesis made of expanded polytetrafluoroethylene (ePTFE), designed by Artivion (formerly Jotec GmbH) to meet the rigorous demands of vascular surgery. Utilizing the innovative "Bipore" technology, this graft offers a balance between surgical handling and long-term patency. It serves as a reliable solution for peripheral vascular procedures, available in both standard and heparin-coated versions to address specific clinical needs.

2. Core Technologies

Bipore Wall Design: The graft features a unique wall structure composed of two layers with different fibril lengths. This specific architecture is engineered to reduce thrombogenicity while promoting optimal tissue integration and cellular ingrowth.

Extra ePTFE Wrap: To ensure maximum safety, the graft body is reinforced with an additional ePTFE wrap. This enhancement significantly improves suture retention and provides high burst strength resistance.

Helical Reinforcement: For procedures requiring extra stability, models with spiral (helical) support are available. This reinforcement prevents kinking and compression, yet remains easily "peelable" for customized placement by the surgeon.

Orientation Marking: A printed longitudinal line assists the surgeon in preventing torsion during implantation and provides immediate visual confirmation of the graft's diameter and wall thickness.

3. Technical Specifications

Material: 100% Expanded Polytetrafluoroethylene (ePTFE).

Wall Thickness: Available in Standard Wall and Thin Wall options to suit various anatomical requirements.

Configurations: Offered in Straight and Tapered (conical) shapes.

Reinforcement: Choice of reinforced (spiral-supported) or non-reinforced versions.

Dimensions: Diameters ranging from 5mm to 10mm; lengths available from 10cm up to 80cm.

4. Clinical Advantages

Enhanced Hemocompatibility: The FlowLine Bipore HEPARIN model utilizes a covalent and ionic bonding process to fix heparin to the luminal surface. This non-leaching technology mimics the natural endothelium’s antithrombogenic properties, significantly reducing the risk of early graft occlusion.

Proven Patency Rates: Clinical data (including multicenter randomized trials led by experts such as Prof. Frank Vermassen) indicate that heparin-bonded ePTFE grafts show superior primary patency rates compared to non-bonded grafts, particularly in challenging below-the-knee bypasses.

Superior Handling & Suturing: The graft’s soft and flexible texture allows for easy needle penetration and excellent "suture-hole" sealing, minimizing the risk of anastomotic bleeding.

5. Indications and Applications

FlowLine Bipore vascular grafts are indicated for use in the following surgical procedures:

Peripheral Bypass Surgery: Femoropopliteal and femorodistal bypasses.

Arterial Reconstruction: Repair of vessels following trauma or for the treatment of aneurysmal diseases.

Dialysis Access: Arteriovenous (AV) grafting (specifically the spiral-reinforced models).