CARDIOVASCULAR
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PERCUTANEOUS CLOSURE OF FEMORAL ACCESS SITES

Prostar™ XL Percutaneous Vascular Surgical System offers percutaneous surgical repair of femoral access sites 8.5 to 10F. Other features of the Prostar™ XL PVS System include:

  • Trackable sheath with atraumatic tip
  • Rotational Hub allows for easy dilation during advancement
  • Provides secure vascular closure

 

Source: Data on file at Abbott.

SECURE

  • Uses two braided polyester sutures and four nitonol needles to provide a secure closure   
  • Vascular access can be maintained throughout deployment  

CLOSE 

  • Percutaneous vascular closure device  
  • Integrated pre-dilator to facilitate device placement 

IMPROVED OUTCOMES AS COMPARED TO MANUAL COMPRESSION   

  • Reduces time to hemostasis, ambulation and discharge1
  • Improves patient comfort1 and reduces access site complications2
REFERENCES

1. Baim, Donald S., et al. "Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate and discharge (STAND I and STAND ii) trials." American Journal of Cardiology 85.7 (2000): 864-869.
2. Noguchi, T., et al. "A Randomised Controlled Trial of Prostar Plus for Haemostasis in Patients After Coronary Angioplasty." European Journal of Vascular and Endovascular Surgery 19.5 (2000): 451-455.

Prostar Close Access Sites

Prostar Secure Closure

Prostar Improved Outcomes

*As compared to manual compression

Prostar Closure System Information

Designed for use in 8.5-10F femoral artery access sites following catheterization procedures.

Product Code/ Catalog # 12322-01

Sold with 5 systems per box

Included in Prostar™ XL System Package: 1 Prostar™ XL Device, 1 Knot Pusher

PRODUCT INFO

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IMPORTANT SAFETY INFORMATION

rx-only-logo Prostar™ XL  Percutaneous Vascular Surgical System

INDICATIONS FOR USE

The Prostar™ XL PVS System is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to hemostasis and time to ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 8.5F to 10F sheaths. (Refer to PRECAUTIONS, SPECIAL PATIENT POPULATIONS sections).

CONTRAINDICATIONS

None known.

WARNINGS

The outer pouch of the Prostar™ XL PVS System and the individual accessories provides the sterile barrier.
Do not use the Prostar™ PVS System or accessories if the packaging or sterile barrier have been previously opened or damaged, or if the components appear to be damaged or defective.
DO NOT RESTERILIZE OR REUSE. The Prostar™ XL PVS System and accessories are intended for single use only. Do not use the Prostar™ XL PVS System if the puncture site is proximal to the inguinal ligament as this may result in a retroperitoneal hematoma.

PRECAUTIONS

1. The Prostar™ XL PVS device and accessories should only be used by physicians (or other healthcare professionals authorized by or under the direction of such physicians) after they have been trained in the use of the Prostar™ XL PVS System and accessories, e.g., participation in a Prostar™ XL PVS System training program or equivalent.

2. Observe sterile technique at all times when using the Prostar™ XL PVS System. Employ appropriate groin management, as per hospital protocol, post procedure and post hospital discharge to prevent infection.

3. Use a single wall puncture technique. Do not puncture the posterior wall of the artery.

4. Adequate knot security requires accepted surgical technique as warranted by surgical circumstances and the experience of the operator.

5. There are no reaccess restrictions if previous arteriotomy repairs were achieved with an Abbott Vascular Suture Mediated Device.

6. Do not insert the Prostar™ XL device into the femoral artery at an angle greater than 45 degrees to the longitudinal plane of the artery.

7. Do not advance or withdraw the Prostar™ XL device against resistance until the cause of that resistance has been determined (see CLINICAL PROCEDURE-Device Placement section). Excessive force used to advance or torque the Prostar™ XL device should be avoided as it may lead to significant arterial damage and / or breakage of the device, which may necessitate intervention and / or surgical removal of the device and arterial repair.

8. If excessive resistance in advancing the Prostar™ XL device is encountered, withdraw the Prostar™ XL device over a 0.038” (or smaller) guide wire and reinsert the introducer sheath or use conventional compression therapy.

9. In the event suture breakage occurs after an initial knot has been tied, care should be taken to avoid excessive force if the reintroduction of the Prostar™ XL device or introducer sheath is required. Any resistance to introduction should result in advancement of an introducer sheath small enough to be introduced without undue force.

10. If significant blood flow is evident through or around the barrel of the Prostar™ XL device, do not deploy needles. Remove the Prostar™ XL device over a 0.038” (or smaller) guide wire and insert an appropriately sized introducer sheath.

11. Remove the Prostar™ XL sheath before tightening the suture. Failure to remove the sheath prior to tightening the suture may result in detachment of the tip of the sheath.

12. Do not attempt to re-deploy Prostar™ XL needles after the needles have been “backed-down” into the sheath (refer to the TECHNIQUE FOR NEEDLE BACK-DOWN section).

13. In the event bleeding from the femoral access site persists after the use of the Prostar™ XL device and accessories, use conventional compression therapy.

ADVERSE EVENTS

The following adverse events have been reported and may occur include • Device Malfunction • Device Complication • Vascular Repair • Ultrasound Guided Compression • Transfusion • Infection Requiring IV Antibiotics • Hematoma > 6 cm • AV Fistula • Nerve Injury • Pseudoaneurysm

Prior to use, please reference the Instructions for Use at eifu.abbottvascular.com for more information on indications, contraindications, warnings, precautions, and adverse events.

IMPORTANT SAFETY INFORMATION

AP2946414-WBU Rev. B

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.