FemoStop™ GoldHow to Use

Content FemoStop Gold Femoral anatomy How to Use Compression Time Example Clinical Highlight: Rapid Ambulation

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31. 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.

Fully Integrated Compression OffersPrecise, Efficient Hemostasis.The FemoStop™ Gold compression assist device includes an integrated digital manometer and transparent, inflatable dome that offer precise, hands-free femoral artery compression. Compared to manual compression, FemoStop Gold has been shown1 to help achieve hemostasis quicker and more comfortably, while helping to improve staff efficiency.

Femoral Anatomy and Arterial Puncture Site

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ASIS

(anterior superior iliac spine)

Inguinal ligament

Femoral head

Deep femoral artery (profunda)

Common femoral artery

Pubic tubercle

Femoral bifurcation

Superficial femoral artery

Figure: Right thigh

External iliac artery

Arterial Puncture SiteThe arterial puncture is usually made in the common femoral artery, below the inguinal ligament and above the bifurcation.

How to Use – Step 1 & 2

1. Activate pump

Prior to activating the pump loosen the control knob to enable pulling the red battery release. Pull the red battery release in the direction of the arrow.

2. Position belt and check pedal pulsePosition belt in line with puncture site(s), equal on both sides. Check pedal pulse to determine what is a normal pedal pulse for the patient.

For Compression of the Femoral Artery or Vein after Vessel Cannulation

How to Use – Step 3

3. Remove lid

Peel back lid, keeping the dome sterile.

4. Position domeCenter dome over arterial puncture (superior and medial to skin incision).Keep sheath hubs clear of dome rim.

How to Use – Step 4

One of the most important things to remember when applying FemoStop apply pressure to the arterial puncture and not in the skin incision.

Correct Wrong

How to Use – Step 5

5. Attach belt

Attach belt to arch and tighten firmly. Ensure arch is level and square across the groin area. Adjust by pulling on appropriate corner of belt to make arch perpendicular to femoral compression site.

How to Use – Step 6

6. Remove sheaths

Inflate dome to 20–30 mmHg: remove venous sheath (if applicable).*

Further inflate to 60–80 mmHg and remove arterial sheath (if applicable).

Then quickly increase pressure in dome to be +10–20 mmHg greater than systolic BP or higher a necessary to maintain initial hemostasis.

Once the device has reached the desired pressure you may close the pinch clamp on the tubing to ensure pressure maintenance.

* To minimize the risk of AV-fistula formation, venous hemostasis should be achieved prior to the removal of the arterial sheath.

How to Use – Step 7

7. Compression time

After a maximum of 3 minutes, lower to a maintenance pressure until limb perfusion is restored to baseline and hemostasis is maintained. Check pedal pulse periodically to confirm that flow remains in vessel.

If flow is absent, slowly lower the pressure until palpable pedal pulse.

After appropriate duration as defined by hospital guidelines; lower by 10–20 mmHg every 2-3 minutes until you reach zero. Leave in place at low pressure if appropriate. Remove carefully. Dress wound. Discard entire device.

Compression Time Example*

* Found in the FemoStop Instructions for Use.** After max three minutes: lower to mean arterial pressure. Check pedal pulse.*** The length of compression depends on factors which vary, such as sheath size

and anticoagulation status.

Clinical Highlight: Rapid AmbulationRapid Ambulation after Coronary Angiography via Femoral Artery Access:

A Prospective Study of 1,000 Patients*

OBJECTIVE

The aim of this study was to assess the safety and efficacy of a 90-minute bed rest protocol for patient undergoing elective 6 F coronary angiography via the right femoral artery.

BACKGROUND

Following cardiac catheterization, reducing the period of immobilization has been shown to have beneficial effects on patient comfort. Previously, immobilization times of up to two hours has been shown to be safe.

METHODS

One thousand consecutive patients undergoing elective daytime coronary angiography were studied. A novel protocol with a commercially available compression device to mobilize patients after 90 minutes of bed rest (Figure 1) was used.

RESULTS

Of 1,000 patients, one had a minor bleed that was successfully treated with manual compression followed by a pressure dressing. Two patients developed pseudoaneurysms, one of whom required a transfusion and surgery. No other patients required a transfusion or experienced hemodynamic instability. Thirteen patients had delayed discharge, most commonly due to a delay in obtaining ultrasound scans to exclude pseudoaneurysm.

CONCLUSION

Results demonstrate that early mobilization (90 minutes) is feasible and safe for patients undergoing elective coronary angiography performed via the right femoral artery.

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* Scott Gall, MD, Aamir Tarique, MD, Arun Natarajan, MD, Azfar Zaman, MD, Cardiology Department, Freeman Hospital, Newcaste-upon-Tyne, United Kingdom and Leicester Royal Infirmary, United Kingdom, Journal of Invasive Cardiology 2006;18:106-108.

Practical TipsSnug belt fitFor successful compression, the system must be snug and secure around the patient’s hips before pressure is applied.

Do not over-tighten the belt.

Correctly positioned throughout the procedureFor successful compression, the system must be correctly positioned throughout the procedure so that pressure is

applied to the point intended.

Obese PatientsOn very obese patients, it may be necessary to tighten the belt slightly more to enhance downward compression.

Placement of the system may not be suitable on large patients, or patients with very wide hips as the belt may be too short. An abdominal strap/tape may be used to pull excessive adipose tissue away from dome.

Careful monitoringCareful monitoring of the dome pressure during the initial period of use is recommended, as the elastic material of the

dome may stretch slightly during the first few minutes. You may notice a slight drop in pressure on the manometer. If this occurs, reinflate to initial pressure.

Pinch clamp open when increasing or decreasingEnsure that the pinch clamp is open when increasing or decreasing the pressure.

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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 1742-11

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