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Impra™ Vascular Grafts
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Device-Type
Hybrid Vascular Graft
Manufacturer
BD
IMPRA® ePTFE vascular grafts are constructed of expanded polytetrafluoroethylene (ePTFE). IMPRA CARBOFLO® ePTFE vascular grafts also contain carbon impregnated into the inner portions of the graft walls.
Features and Benefits
- Proven patency when compared to wrapped grafts
- Designed for fewer intervention
- Promotes better tissue incorporation
Safety informations
Indications for Use
IMPRA® ePTFE grafts are indicated for use as vascular prostheses
Straight, Tapered, Short Tapered, Stepped, CENTERFLEX™ Graft and ENDFLEX™ Graft Configurations are intended for use as subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of peripheral arterial blood vessels. Tapered, short tapered, and stepped configurations may help minimize the risk of steal syndrome and high cardiac output. CENTERFLEX™ graft and ENDFLEX™ graft configurations have a non-removable external spiral support (beading) and can be used where resistance to compression or kinking is desired.
IMPRA FLEX™ Graft Configurations are intended for bypass or reconstruction of peripheral arterial blood vessels and have removable spiral support (beading) over the entire graft. These grafts can be used where resistance to compression or kink is desired. Insufficient clinical data are available on which to base any conclusions regarding the use of Thinwall grafts in blood access or to support the use of IMPRA® vascular grafts for applications involving; pulmonary arteries, cerebral arteries, coronary arteries, brachiocepha
Contraindications
None known.
Warnings
1. All IMPRA® ePTFE vascular grafts are supplied sterile and nonpyrogenic unless the package is open or damaged. IMPRA® ePTFE vascular grafts are sterilized by ethylene oxide. Each graft is intended for single patient use only. DO NOT RESTERILIZE.
2. This device has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications.
3. Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.
4. Do not use after expiration date printed on the label.
5. Anastomotic or graft disruption has been associated with Axillofemoral, Femoral Femoral, or Axillobifemoral bypass procedures if implanted improperly. Refer to Specific Operative Procedures (ExtraAnatomic Bypass Procedures) for further instructions. Thinwall and IMPRA FLEX™ Thinwall grafts are NOT recommended for these types of bypass procedures.
6. For Extra-Anatomic procedures, (e.g., Axillofemoral, Femoral Femoral, or Axillobifemoral Bypass) the patient should be cautioned that sudden, extreme or strenuous movements should be totally avoided for a period of at least six to eight weeks to allow for proper stabilization of the graft. Routine activities such as raising the arms above the shoulders, reaching out in front, extended reaching, throwing, pulling, striding or twisting should be avoided.
7. IMPRA® ePTFE grafts do not stretch (are non-elastic) in the longitudinal direction. The correct graft length for each procedure must be determined by considering the patient’s body weight, posture, and the range of motions across the anatomical area of graft implantation. Failure to cut the grafts to an appropriate length may result in anastomotic or graft disruption, leading to excessive bleeding, and loss of limb or limb function, and/or death.
8. Aggressive and/or excessive graft manipulation when tunneling, or placement within a too tight or too small tunnel, may lead to separation of the spiral beading and/or graft breakage.
9. When embolectomy or balloon angioplasty catheters are used within the lumen of the graft, the inflated balloon size must match the inner diameter of the graft. Over-inflation of the balloon or use of an inappropriately sized balloon may dilate or damage the graft.
10. Do not remove the external spiral support (beading) from any CENTERFLEX™ graft or ENDFLEX™ graft. Attempts to remove the beading may damage the graft wall. If damage occurs, discard the graft.
11. Do not cannulate IMPRA FLEX™ grafts with external support over the full length of the graft or the externally supported portion of CENTERFLEX™ or ENDFLEX™ grafts. Cannulation at these sites may lead to beading embolization and/or pseudoaneurysm formation.
12. Avoid repeated or excessive clamping at the same location on the graft. If clamping is necessary, use only atraumatic or appropriate vascular smooth jawed clamps to avoid damage to the graft wall.
13. Exposure to solutions (e.g., alcohol, oil, aqueous solutions, etc.) may result in loss of the graft’s hydrophobic properties. Loss of the hydrophobic barrier may result in graft wall leakage. Preclotting of this graft is unnecessary.
14. Avoid excessive graft manipulation after exposure to blood or body fluids. Do not forcibly inject any solution through the lumen of the graft, or fill the graft with fluid prior to pulling it through the tunnel as loss of the graft’s hydrophobic properties may occur. Loss of the hydrophobic barrier may result in graft wall leakage.
15. Do NOT expose IMPRA® ePTFE grafts to temperatures greater than 500°F (260°C). PTFE decomposes at elevated temperatures producing highly toxic decomposition products.
16. After use, the product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practice and applicable local, state and federal laws and regulations.
17. During tunneling create a tunnel that closely approximates the outer diameter of the graft. A tunnel that is too loose may result in delayed healing and may also lead to perigraft seroma formation.
Potential adverse events
Potential complications which may occur with any surgical procedure involving a vascular prosthesis include, but are not limited to: disruption or tearing of the suture line, graft, and/or host vessel; suture hole bleeding; graft redundancy; thrombosis, embolic events, occlusion or stenosis; ultrafiltration; seroma formation; swelling of the implanted limb; formation of hematoma or pseudoaneurysm; infection; aneurysm/dilation; blood leakage; hemorrhage; steal syndrome; and/or skin erosion.