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Occlusafe®

Temporary Occlusion Balloon Catheter

Description

Microballoon Interventions a Technical Revolution in Transarterial Embolization

Terumo Interventional Oncology Division presents Occlusafe, an occlusive micro-balloon.

Through Pressure Gradient Effect, Occlusafe as micro-balloon catheter, offers the ability to redistribute blood flow and access the microcirculation, leading to an increased accumulation of therapeutics into the target lesion with minimal off-target embolization. This may be associated with improved clinical outcomes in challenging lesions3.

Characteristics

Large Lesions Challenges: 

Large lesions partially respond to current TACE treatment due to a poor uptake of embolic. Multiple or combined treatments are required to reach a complete response.

Flow Distribution

Through Pressure Gradient Effect, Balloon Occlusion with Occlusafe offers the ability to redistribute blood flow and access the microvascular circulation, leading to an increased accumulation of therapeutics into the target lesion1 with minimal off-target embolization2.

Access to Microvascular Circulation

Balloon Occlusion with Occlusafe allows a better visualization for improved diagnosis and higher uptake of embolic into the target lesion1.

Excellence in Navigability

Terumo excellence in lesion access technology guarantees for a superb precision and accuracy in navigation through complex vessel anatomies.

Expected Benefits  from Micro Balloon Embolization (MBE)

  • Greater tumor or radiological response3
  • Improved clinical outcome4-6
  • Better diagnosis thanks to more visibility1
  • Full protection against reflux7

Clinical evidence

Balloon-Occluded Transcatheter Arterial Chemoembolization (b- TACE) for Hepatocellular Carcinoma Performed with Polyethylene-Glycol Epirubicin-Loaded Drug-Eluting Embolics: Safety and Preliminary Results

Case study
Initial Experience with Balloon-Occluded Trans-catheter Arterial Chemoembolization (B-TACE) for Hepatocellular Carcinoma

Case study
Hemodynamic Changes on Cone-Beam Computed Tomography during Balloon-Occluded Transcatheter Arterial Chemoembolization Using Miriplatin for Hepatocellular Carcinoma: A Preliminary Study

Case study
See all clinical evidence

General specifications

​Balloon
​ ​
​Catheter O.D
​​Catheter Length

​Dead Volume Space (mL)
​Compatible GW

​Compatible Catheter minimum lumen size

​Max Size
​Length
​Injection Volume
​Distal shaft
​Proximal shaft
​Tip
​Main lumen
​Inflation lumen
​4.0 mm
​10 mm
​0.1 mL
​0.90 mm (2.7 Fr)
​0.94 mm (2.8 Fr)
​1.9 Fr
110 cm
130 cm
150 cm​
​0.24
0.27
0.30
​0.34
0.36
0.38
​0.014"/ 0.36 mm
​0.040"/ 1.02 mm

​Including connector part

Item specifications

Occlusafe

Item referenceOcclusafe length (cm)
OB*T41140N110
OB*T41340N130
OB*T41540N150

 

Occlusafe and Radifocus Guidewire GT with gold coil pack

​Item reference​Occlusafe length (cm)
​OB*T41140N_GTPACK​110
​OB*T41340N_GTPACK​130
​OB*T41540N_GTPACK​150

Please quote above item reference codes when placing an order.

References

Note: Comparison is done between TACE performed with Occlusafe micro-balloon catheter and TACE with a standard micro-catheter.

1. Irie Toshiyuki (2013): Dense accumulation of lipiodol emulsion in hepatocellular carcinoma nodule during selective balloon-occluded transarterial chemoembolization: measurementof balloon occlude arterial stump pressure. Cardiovasc Intervent Radiol. DOI: 10.1001/s00270-012-0476-z 

2. Terumitsu Hasebe; Minimally Invasive Therapy & Allied Technologies. 2015 Apr;24(2):94-100. doi: 10.3109/13645706.2014.951657. Epub 2014 Sep 29. PubMed. 

3. Hriotaka Arai: Hepatology Research (2015): Safety and efficacy of balloon-occluded trancatheter arterial chemoembolization using miriplatin for hepatocellular carcinoma; 45. 663-666 

4. Takayasu K, Muramatsu Y, Maeda T, Iwata R, Furukawa H, Muramatsu Y, Moriyama N, Okusaka T, Okada S, Ueno H. Targeted transarterial oily chemoembolization for small foci of hepatocellular carcinoma using a unified helical CT and angiography system: analysis of factors affecting local recurrence and survival rates. AJR Am J Roentgenol 2001; 176: 681-688 [PMID: 11222205 DOI: 10.2214/ajr.176.3.1760681] 

5. Hayashi K, Ina H, Tezuka M, Okada Y, Irie T. Local therapeutic results of computed tomography-guided transcatheter arterial chemoembolization for hepatocellular carcinoma: results of 265 tumors in 79 patients. Cardiovasc Intervent Radiol 2007; 30: 1144-1155 [PMID: 17909884 DOI: 10.1007/s00270-007-9169-4] 

6. Hatanaka T, Arai H, Shibasaki M, Tojima H, Takizawa D, Toyoda M, Takayama H, Abe T, Sato K, Kakizaki S, Yamada M. Factors predicting overall response and overall survival in hepatocellular carcinoma patients undergoing balloon-occluded transcatheter arterial chemoembolization: A retrospective cohort study. Hepatol Res 2018; 48: 165-175 [PMID: 28500686 DOI: 10.1111/hepr.12912] Data on files. Reference OS-003. Terumo Europe NV.

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