Abbott GRAFTMASTER RX Coronary Stent Graft System (SD 4.0)

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Product Details:

Measurement Range Stent Diameter: 4.0 mm
Instruments Type Interventional Cardiology Device
Shelf Life Up to 3 years
Function Seals coronary artery perforations
Usage Type Single use
Features Balloon expandable, rapid exchange delivery, covered stent design
Storage Instructions Store in original packaging, at controlled room temperature
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Abbott GRAFTMASTER RX Coronary Stent Graft System (SD 4.0) Price And Quantity

Abbott GRAFTMASTER RX Coronary Stent Graft System (SD 4.0) Product Specifications

Equipment Type Coronary Stent Graft System
Usage Type Single use
Instruments Type Interventional Cardiology Device
Measurement Range Stent Diameter: 4.0 mm
Color Transparent/metallic
Real-Time Operation Yes
Function Seals coronary artery perforations
Shelf Life Up to 3 years
Material PTFE (Polytetrafluoroethylene) covered stent with stainless steel
Portable Yes
Operating Type Manual via catheter delivery system
Wall Mounted No
Features Balloon expandable, rapid exchange delivery, covered stent design
Technology PTFE covered stent on a rapid exchange (RX) balloon dilatation catheter
Use Treatment of coronary artery perforations
Condition New
Storage Instructions Store in original packaging, at controlled room temperature

Latex Status Latex Free
Maximum Shelf Temperature 30C
Compatibility 0.014\\
Product Name Abbott GRAFTMASTER RX (SD 4.0)
Single Use Yes
Indication Coronary artery perforation, saphenous vein graft perforation
Sterility Sterile EO (Ethylene Oxide)
Packaging Individually packed, sterile pouch
Balloon Diameter 4.0 mm
Balloon Length 16 mm
Radiopacity Enhanced with radiopaque markers
Minimum Shelf Temperature 15C
Catheter Type Rapid Exchange (RX)
Stent Material Cobalt Chromium with expanded PTFE (ePTFE) sleeve
Maximum Inflation Pressure 16 atm (Rated Burst Pressure)
Guide Catheter Compatibility 6 Fr
Balloon Compliance Semi-Compliant

Product Description

Brand	Abbott
Stent Diameter (mm)	4.0
Stent Length (mm)	16, 19, 26, 29
CAT No	1012819-16, 1012819-19, 1012819-26, 1012819-29
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.

Rapid Exchange Delivery for Emergency Situations

The GRAFTMASTER RX system is engineered for swift deployment in critical scenarios such as coronary artery perforations. Its rapid exchange catheter platform simplifies handling, allowing for quick insertion and precise positioning. Enhanced with radiopaque markers, clinicians achieve optimal visualization during placement, reducing procedure time and improving patient outcomes.

Advanced Stent Graft Technology

Combining a cobalt chromium stent with a PTFE (ePTFE) sleeve, the device provides robust vessel support and effective perforation sealing. Balloon expandable, it adapts to various lesion characteristics while minimizing the risk of additional damage. The systems compatibility with standard 0.014" guidewires and 6 Fr guide catheters ensures procedural versatility.

Safety and Storage Assurance

Each stent graft is supplied in a sterile, latex-free pouch to protect against contamination. With a shelf life of up to three years under controlled temperatures (15C30C), users can confidently manage inventory for readiness. The device is intended for single use, ensuring maximum patient safety and consistent product quality.

FAQs of Abbott GRAFTMASTER RX Coronary Stent Graft System (SD 4.0):

Q: How is the Abbott GRAFTMASTER RX (SD 4.0) stent graft system used during a procedure?

A: The GRAFTMASTER RX is deployed using a rapid exchange balloon catheter over a 0.014" guidewire. It is inserted into the affected coronary artery via a 6 Fr guide catheter, then manually inflated up to 16 atm to seal the perforation with its PTFE-covered stent.

Q: What are the primary indications for the Abbott GRAFTMASTER RX (SD 4.0)?

A: This system is intended for sealing coronary artery perforations and saphenous vein graft perforations that occur during percutaneous coronary interventions (PCI), providing immediate vessel integrity restoration.

Q: When should the GRAFTMASTER RX (SD 4.0) be selected over other stents?

A: Choose this system when a perforation is detected during coronary or saphenous vein graft interventions, as its covered stent design provides rapid sealing and minimization of further blood loss.

Q: Where can the Abbott GRAFTMASTER RX (SD 4.0) be stored before use?

A: The device should be stored in its original, sterile pouch at a controlled room temperature between 15C and 30C to maintain its three-year shelf life and sterility.

Q: What process ensures the sterility of the GRAFTMASTER RX (SD 4.0)?

A: The device is sterilized using ethylene oxide (EO) and is individually packed in a sterile, latex-free pouch, ensuring it is ready for immediate use upon opening.

Q: What are the benefits of using a PTFE-covered, balloon-expandable stent graft?

A: This design offers both the flexibility for complex vessel anatomy and a reliable seal for vessel perforations. The PTFE cover prevents blood leakage, while balloon expansion enables precise deployment.

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