Current
CaveoVasc® is a protection system to reduce bleeding complications during catheter directed thrombolysis.
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Less bleeding complications
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Increase in success rate of catheter directed thrombolysis
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Cost reduction for hospitals
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Intuitive use
CaveoVasc® - the revolutionary protection system for thrombolysis therapy
After the good results of the First in man study CaveoVasc® got CE Certificate as a medical product in 2020. It impresses with its patented double balloon technology: the anchor balloon fixes the CaveoVasc® in the
tissue and the protection balloon augments the puncture site. The com-pression of the puncture channel and the puncture site reduces the risk of bleeding during the thrombolysis therapy. After the lysis therapy, CaveoVasc® is completely removed and nothing remains
in the vascular system or in the body!
Why CaveoVasc®?
Catheter directed thrombolysis has a high bleeding complication rate. The procedure often must be terminated without success.
30%
of the patients have minor bleeding
in the groin around the puncture site.
*Abraham et al. Int J Surg. 2011;9(8):632-5
A
Review of the
complications of lysis
and the possibility of protection with CaveoVasc was published in 2021
15%
of the patients have major bleeding in the groin.
**Agle et al. Ann Vasc Surg. 2010 Jul;24(5):609-14
Bleeding Complications with high follow-up costs
Blood transfusion
€ 300
extra days 'Intermediate care'
€ 1,800
Amputation
€ 7,500
extra days in hospital
€ 1,500
Coagulation factor
€ 1,000
Treatment of groin hematoma
€ 3,500
Extra cost
€ 14,000
A New Protection Device to Avoid Major Bleeding at Puncture Site- Results from the First in Man Study
Primary endpoints:
Safety:major bleeding at the puncture site from
START of the CDT procedure to the END of the CDT procedure
Performance endpoint: length of CDT (hours)
Secondary endpoints:
Rate of patients completing the CDT without early interruption due to access site complications
Rate of successful thrombolysis without bleeding complications
Pain at the access site using a pain scale 6 Hours after start of the CDT
No major bleeding at puncture site
in FIH Study
No relevant hematoma
at puncture site
No treatment failure
No pain due to balloon technique
Download
the original
study (PDF)
How CaveoVasc® works
CaveoVasc
Guide wire in the femoral artery
Puncture and guide wire placement in the femoral artery
Place the CaveoVasc® over the wire
After a small skin incision, the
CaveoVasc® is positioned over the guide wire in the tissue.
Removing the Locator -
Blood flow shows the correct location
As soon as the locator with the inflow opening is in the artery, blood flows back and the correct position is guaranteed.
Filling the fixation balloon
The filled fixation balloon secures the position of CaveoVasc® in the tissue immediately in front of the artery in the extravascular connective tissue.
Placing the sheath for CDT
The sheath can now be advanced into the artery over the guide wire through the shaft of the CaveoVasc®.
Filling the protection balloon.
Start of thrombolysis
The double balloon technique compresses both the puncture channel and the puncture site. Minimizing the risk of bleeding!
Remove the catheter and sheath
The balloons remain inflated while the endovascular catheter/sheath is removed.
Removal of CaveoVasc®
After removing the catheter/sheath, the balloons are emptied and CaveoVasc® will be removed. Nothing remains in the vascular system and nothing remains in the patient. Vascular closure can be done according to the hospital practice.
You will receive a set consisting of
1 body
2 locator
3 valve
4 syringe.
