FUSION BIOLINE Vascular Grafts

Description

FUSION: Revolutionizing Vascular Grafts, Inside and Out

The Maquet line of FUSION grafts merges ePTFE with PET to offer vascular surgeons the best of both materials:

• Easy handling of polytetrafluoroethylene (ePTFE)
• Minimal suture hole bleeding compared to ePTFE grafts

FUSION BIOLINE vascular grafts build on this revolutionary design with the addition of a heparin coating designed to enhance thromboresistance.

Proven Graft Technology

BIOLINE coating is composed of recombinant human albumin and heparin—a substance widely known as a safe and effective anti-thrombogenic. Covalent bonds between the heparin molecules and the albumin layer provide stability of the coating.

The BIOLINE coating has successfully been used on Maquet’s Cardiopulmonary line since 1995. BIOLINE coating on the Cardiopulmonary products has demonstrated a reduction in clotting activity¹and a reduction of platelet adhesion and thrombi creation.^2,3

FUSION BIOLINE is FDA Cleared for repairing or replacing peripheral arteries

Proven Graft Technology

• Axial compliance designed to help reduce tension on the anastomoses*
• High suture retention strength and durability*
• Kink resistant to help maintain blood flow across joints
  and bends*
• Minimal suture hole bleeding for improved hemostasis*
• Crush resistant to help enhance flow dynamics*

Instructions for Use

Prescriptive Information

Prior to use please see the complete ‘Instructions for Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.

CAUTION:  Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.

Indications

FUSION BIOLINE Vascular Grafts are designed to repair or replace peripheral arteries.

Contraindications

• FUSION BIOLINE Vascular Grafts should not be used as a coronary artery replacement, as cardiovascular patch material, or for soft tissue repair.
• DO NOT use FUSION BIOLINE Vascular Grafts in patients with an allergy or hypersensitivity to heparin, including those patients who have had a previous incidence of HITT (heparin induced thrombocytopenia thrombosis).
• DO NOT use FUSION BIOLINE Vascular Grafts in patients with potential allergy to PTFE, Polycarbonate Urethane, or Polyester (polyethylene terephthalate).

Warnings and Precautions

• Grafts contaminated with blood or bodily fluids cannot be cleaned for reuse or resterilized.
• STERILE – DO NOT RESTERILIZE – SINGLE USE ONLY
  Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
• After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
• See IFU for additional general device precautions and procedure specific precautions.

Potential Adverse Effects

Potential adverse events (in alphabetical order) which may be associated with the use of a FUSION BIOLINE Vascular Graft include but are not limited to bleeding, embolism, hematoma, hemorrhage, infection, mechanical disruption or tearing of the suture line, graft and/or host vessel, obstruction, occlusion, pseudoaneurysm, seroma, skin erosion, stenosis, swelling in the implanted limb, thrombosis.  Please be aware that potential adverse effects may arise even with the proper use of medical devices.  Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.