FemoStop

TM Femoral Compression System for Ultrasound-Guided Compression Repair (UGCR) of Femoral Pseudoaneurysm

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Module Contents

         Pseudoaneurysm Proven to Reduce Complications Treatment of Pseudoaneurysm Early Treatment Principle of Compression Repair FemoStop Positioning Applying pressure Factors Affecting Success Summary

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Pseudoaneurysm

    False aneurysm Extravascular cavity, pseudoaneurysm sac Presence of flow Not contained by vessel wall Pseudoaneurysm sac Communicating (feeding) tract

Proven to Reduce Complications ¹

,

²

 FemoStop reduces vascular complications following sheath removal  FemoStop helps prevent femoral artery pseudoaneurysm

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1.

2.

Sridhar K, Fischman D, Goldberg S, et al. Peripheral vascular complications after intracoronary stent placement: prevention by use of a pneumatic vascular compression device.

Cathet Cardiovasc Diagn

. 1996:39(3):224-229.

Amin F, Yousufuddin M, Stables R, et al. Femoral haemostasis after transcatheter therapeutic intervention: a prospective randomised study of the angio-seal device vs. the femostop device. Intl J of Cardiol. 2000;76(2-3):235-40.

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Treatment of Pseudoaneurysm

 Treatment by ultrasound-guided compression repair of femoral artery pseudoaneurysms is an Indication for Use in the U.S.

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Early Treatment

 By using FemoStop, compression can be initiated early on the ward, while waiting for duplex ultrasonogram

Principle of Compression Repair

Pseudoaneurysm sac PRESSURE PRESSURE

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Communicating (feeding) tract

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Using FemoStop for UGCR

1. Premedication 2. Baseline blood pressure, distal pulses

3. Ultrasound

4. Demarcate compression site 5. Position FemoStop

6. 20 min. compression

; distal pulses 7. Release pressure

8. Ultrasound

9. Repeat steps 6-8 if necessary 10. Light compression and bed rest

11. Ultrasound

*

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FemoStop Positioning

Pseudoaneurysm Artery Vein

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FemoStop Positioning

 Sterile tape may be used to demarcate the compression site as determined by ultrasound

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FemoStop Positioning

 Apply until ultrasound is available: Pressure on arterial puncture (not skin incision).

PRESSURE Skin Artery Skin incision Arterial puncture Arterial sheath

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Applying Pressure

Apply enough pressure to minimize arterial blood flow

but:

   Do not obliterate flow in the artery itself Do not compress the vein, if possible Do not make compression unbearable for the patient (i.e., 20 mmHg below the patient’s systolic blood pressure)

Applying Pressure

PRESSURE PRESSURE

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Pseudoaneurysm sac Patient’s arterial lumen

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Pressure Duration

Compression time  Up to 300 minutes (in cycles of 20 minutes)  Mean compression time approximately 40 minutes

Pressure Duration

Short compression cycles   (20 min*):  Prevent vessel thrombosis Prevent nerve injury Prevent skin abrasion/necrosis

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*Chatterjee J, et al.

Catheter Cardiovasc Interv

. 1999;47:304-9.

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Factors Affecting Success

   Ability to compress Anticoagulation status Pseudoaneurysm size PRESSURE Patient’s arterial lumen

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Factors Affecting Success

   Ability to compress Anticoagulation status Pseudoaneurysm size     One or more compartments Age of the pseudoaneurysm (epithelialization of the tract and more fibrous capsule) Neck width Short feeding tract <10 mm

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Summary

  FemoStop:  Helps prevent pseudoaneurysms in the first place UGCR method is relatively easy Makes UGCR a NON-labor-intensive method of treatment  A ”first line” treatment to help prevent further development of a bleeding complication

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Rx Only Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Product referenced is approved for CE Mark.

FemoStop is designed, developed and manufactured by St. Jude Medical Systems AB. FemoStop, RADI, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies. ©2011 St. Jude Medical, Inc. All rights reserved.

IPN 1691-11