GRAFTMASTER RX Coronary Stent Graft System (SD 4.8)

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Product Details:

Function To seal or exclude perforations in coronary arteries during angioplasty or stenting procedures
Usage Type Single-use, disposable
Accuracy Precise stent deployment
Storage Instructions Store at room temperature, away from direct sunlight and moisture
Instruments Type Interventional cardiology device
Features Covered stent, Rapid Exchange delivery, PTFE covering, radiopaque markers, flexibility
Shelf Life Up to 2 years (if unopened and stored properly)
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GRAFTMASTER RX Coronary Stent Graft System (SD 4.8) Price And Quantity

GRAFTMASTER RX Coronary Stent Graft System (SD 4.8) Product Specifications

Power Source Not required (manual/hand-operated)
Condition New
Function To seal or exclude perforations in coronary arteries during angioplasty or stenting procedures
Color Metallic (stent), white (catheter)
Use Percutaneous coronary intervention to treat coronary artery perforations
Wall Mounted No
Dimension (L*W*H) Catheter length 145 cm, Stent diameter 4.0 mm, Stent length 8 mm
Usage Type Single-use, disposable
Operating Type Manual
Real-Time Operation Yes
Equipment Type Coronary Stent Graft System
Instruments Type Interventional cardiology device
Features Covered stent, Rapid Exchange delivery, PTFE covering, radiopaque markers, flexibility
Weight Lightweight, device weight negligible
Portable Yes
Accuracy Precise stent deployment
Material Cobalt Chromium with expanded Polytetrafluoroethylene (ePTFE) covering
Storage Instructions Store at room temperature, away from direct sunlight and moisture
Shelf Life Up to 2 years (if unopened and stored properly)
Measurement Range Stent diameter 4.0 mm, Stent length 8 mm
Technology RX (Rapid Exchange)

Delivery System Compatibility 0.014" guidewire compatible
Cross Compatibility Compatible with standard interventional accessories
Intended Patient Population Adults requiring coronary perforation management
Packaging Sterile packaging, individually packed
Stent Model GRAFTMASTER RX SD 4.8
Deployment Mechanism Balloon-expandable
Maximum Recommended Inflation Pressure 16 atm
Sterilization EO sterilized, ready to use
Radiopacity Platinum-iridium markers for visibility under fluoroscopy
Special Note Should only be used by physicians trained in coronary interventions

Product Description

Brand	Abbott
Stent Diameter (mm)	4.8
Stent Length (mm)	16, 19, 26, 29
CAT No	1012821-16, 1012821-19, 1012821-26, 1012821-29
Catheter Length	143 cm

The GRAFTMASTER RX Coronary Stent Graft System is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts 2.75 mm in diameter. The effectiveness of this device for this use has not been demonstrated. Long-term outcome for this permanent implant is unknown at present.

Outstanding Visibility and Performance

With platinum-iridium radiopaque markers, the GRAFTMASTER RX SD 4.8 Stent Graft System delivers superb visibility under fluoroscopy, providing precise control and positioning during deployment. The balloon-expandable design combined with a cobalt chromium structure and ePTFE covering ensures optimal sealing of coronary perforations and secure vessel support during interventions.

Seamless Integration and Compatibility

This stent graft system is compatible with standard 0.014" guidewires and interventional accessories, making it easy to integrate into current catheterization laboratory setups. Lightweight and rapidly exchangeable, its ergonomic design simplifies the procedure for experienced physicians and guarantees efficiency during critical situations.

Safe and Ready-to-Use Design

Delivered sterile and individually packaged, the GRAFTMASTER RX SD 4.8 is EO-sterilized, ensuring patient safety and convenience for the medical team. Its manual, hand-operated deployment requires no external power source, while its disposable, single-use nature minimizes contamination risk and simplifies post-procedure handling.

FAQ's of GRAFTMASTER RX Coronary Stent Graft System (SD 4.8):

Q: How is the GRAFTMASTER RX Coronary Stent Graft System (SD 4.8) deployed during a procedure?

A: The system is manually deployed using a balloon-expandable mechanism after crossing the target site with a 0.014" guidewire. The balloon is inflated (up to 16 atm) to expand the stent and seal the coronary perforation under fluoroscopic guidance.

Q: What is the primary function of this stent graft system?

A: Its main purpose is to seal or exclude perforations that occur in coronary arteries during angioplasty or stenting, providing rapid vessel reinforcement and stopping bleeding efficiently.

Q: When should the GRAFTMASTER RX SD 4.8 be used?

A: It is intended for use in adults experiencing coronary artery perforations during percutaneous coronary interventions. The device should only be used by physicians trained in coronary interventions.

Q: Where can this device be used in a clinical setting?

A: The stent graft system is designed for use in catheterization laboratories equipped for interventional cardiology, where advanced imaging and PCI procedures are performed.

Q: What advantages does the stent offer for physicians and patients?

A: It offers rapid, accurate sealing of vessel perforations, excellent visibility under fluoroscopy, easy integration due to compatibility with standard guidewires, and safe, sterile, ready-to-use packaging. Its flexibility and rapid exchange design further facilitate a smooth procedure.

Q: What are the storage requirements for this device before use?

A: Store the system at room temperature, away from direct sunlight and moisture, and ensure the packaging remains unopened to maintain sterility for up to 2 years.

Q: Is the GRAFTMASTER RX SD 4.8 reusable or disposable?

A: This device is intended for single-use only; it must be disposed of after one procedure to maintain safety and prevent infection.

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