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FemoSeal™

Vascular Closure System

Description

​Active vascular closure

​The FemoSeal vascular closure device uses
3 bioabsorbable
components to actively seal the arteriotomy:


Two bioabsorbable polymer discs

  • An inner disc deployed intra-arterially
  • An outer locking disc deployed on the outer wall of the artery

Suture
Hemostasis is achieved by sealing the arteriotomy between the two discs, which are held together by bioabsorbable sutures complete with friction lock


Characteristics

​Fast, effective, easy to use

  • Instant hemostasis with an easy to use deployment system

Fully bioabsorbable

  • All components of FemoSeal vascular closure device are fully bioabsorbable: two polymer discs held together by a suture

Rapid hemostasis and early ambulation

  • Designed to achieve effective and instant hemostasis. Sealing femoral artery punctures following catheterization procedures promotes rapid ambulation with low vascular complication rates.1
  • The median Time To Hemostasis (TTH) is 1 minute.2

Preparation

Video instructions

 


Procedure

Step by step instructions

1

​Thread the Femoseal device over the guidewire and insert the sheath and dilator into the artery.

2

​Detach the safety catch with dilator and guidewire. When the FemoSeal safety catch with dilator has been retracted a few centimeters (2-4 cm), blood should appear in the proximal part of the sheath, verifying that the sheath is in the artery.

3

​​Deploy the inner disc by pressing down the button completely in one continuous movement

4

Pull back the FemoSeal device until the depressed button springs back. The inner disc establishes hemostasis. Maintain suture tension while deploying the outer locking disc by completely pressing down the button again.

5

Remove the FemoSeal device. Verify hemostasis.

6

After verification, cut the suture below skin level using a sterile instrument. Clean puncture site and apply a sterile dressing so that it can easily be observed during recovery.

Clinical evidence

Item specifications

​Item reference​French size​Guidewire diameter (in)
​C11202​70.038​

References

​1 SCAAR Registry 2009.
Schulz-Schupke S, Helde S, Gewalt S, et al. Comparison of Vascular Closure Devices vs Manual Compression After Femoral Artery Puncture The ISAR-CLOSURE Randomized Clinical Trial. JAMA. 2014;312(19):1981-7.

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