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Occlusafe™

Temporary Occlusion Balloon Microcatheter

Description

Balloon Microcatheter Interventions​ a Technical Revolution in Transarterial Embolization

​​​​Terumo Interventional Oncology Division presents Occlusafe, an occlusive Balloon Microcatheter.

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

Characteristics

​​​Large Lesions Challenges: 

Lesions with a diameter larger than 3 cm could potentially have lower complete response rates after the initial TACE treatment due to poor uptake of embolic. Multiple or combined treatments are required to reach a complete response8,9.

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 less off-target embolization2.

Access to Microvascular Circulation

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

Excellence in Navigability

Terumo excellence in lesion access technology guarantees for precision and accuracy in navigation through complex vessel anatomies7.​

Expected Benefits  from Micro Balloon Embolization (MBE)

  • Improved* tumor response (imaging)3
  • Improved* clinical outcome4-6
  • Better* diagnosis thanks to more visibility1
  • Protection against reflux​7
*vs standard microcatheter​

Preparation

Video instructions

    
 
 

​

Clinical evidence

Balloon occluded TACE (B-TACE) vs DEM-TACE for HCC: a single center retrospective case control study
​Pierleone Lucatelli, Gianluca De Rubeis, Bianca Rocco, Fabrizio Basilico, Alessandro Cannavale, Aurelio Abbatecola, Pier Giorgio Nardis, Mario Corona, Stefania Brozetti, Carlo Catalano and Mario Bezzi

​Lucatelli et al. BMC Gastroenterology(2021)  ​

Balloon occluded TACE (B-TACE) vs DEM-TACE for HCC: a single center retrospective case control study
​Pierleone Lucatelli, Gianluca De Rubeis, Bianca Rocco, Fabrizio Basilico, Alessandro Cannavale, Aurelio Abbatecola, Pier Giorgio Nardis, Mario Corona, Stefania Brozetti, Carlo Catalano and Mario Bezzi

​Lucatelli et al. BMC Gastroenterology(2021)  ​

Balloon-Occluded Transarterial Chemoembolization: In which size range does it perform best? A comparison of its efficacy versus conventional Transarterial Chemoembolization, using Propensity score matching
​Golfieri R. Bezzi M. · Verset G. Fucilli F. Mosconi C. Cappelli A. Paccapelo A. Lucatelli P. Magand N. Rode A. De Baere T.

​​

See all clinical evidence

General specifications

​Balloon

Catheter O.D
Catheter Length

Dead Space Volume (mL)*
Compatible GW

Compatible Catheter minimum lumen size

Diameter
Length
Recommended Inflation Volume
Distal shaft
​Proximal shaft
Dead Space Volume​
Inflation Prime Volume
4.0 mm
10 mm
0.1 mL
0.90 mm (2.7 Fr)
0.94 mm (2.8 Fr)​110 cm
130 cm
150 cm		0.35
0.37
0.40
0.24
0.26
0.30
0.014"/ 0.36 mm
0.040"/ 1.02 mm

*Including connector (hub) part

Item specifications

Occlusafe

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

 

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
Enlarge table

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.

7. Data on files. Reference OS-003. Terumo Europe NV. * vs. standard micro catheter

8. Lammer et al. Cardiovasc Intervent Radiol (2010) 33:41–52

9. Lencioni et al. Semin Intervent Radiol. 2013 Mar; 30(1): 3–11​

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