Flextome™ Cutting Balloon™ Device
Monorail™ Delivery System

Product Information

The Flexibility You Want

• Nylon balloon material designed to provide flexibility, superb compliance and improved puncture resistance
• Atherotomes with Flexpoints provide flexibility and assist in tracking to lesions that may have been previously out of reach.

The Deliverability You Need

• 30% more Deliverable than the Cutting Balloon™ Ultra²™ Device*
• 50% improvement in re-cross compared to the Cutting Balloon™ Ultra²™ Device*

The Predictability You Rely On

• Precise dilatation ^{1, 2}
• Scoring the plaque by severing the elastic and fibrotic continuity of the vessel wall¹
• Dilating the lesion at lower pressures with less recoil^{2, 3}
• Lumen gain through plaque compression instead of vessel wall expansion^{2, 4, 5}

Device Illustration

Additional Information

The Flextome™ Cutting Balloon™ device is a unique** and effective* tool for the mechanical challenges of complex lesions that are often resistant to conventional balloon angioplasty

•  In-Stent Restenosis Lesions – Avoid balloon slippage

– Lesions with a high composition of neo-intimal hyperplasia which offer greater resistance to dilatation and cause balloon slippage ^{6, 7}
– The scoring mechanism of action of the Cutting Balloon™ device allows controlled dilatation while preventing balloon slippage⁸.

•  Ostial and Bifurcation Lesions - Avoid Plaque shift

– Challenging lesion subsets with a higher degree of recoil and potential of plaque shift effect
– The Cutting Balloon™ device successfully dilates while reducing elastic recoil⁹ and allowing more plaque compression with minimal plaque shift and less vessel stretching ^2,4,5

•  Fibrotic lesions – Change lesion compliance

– Resistant lesions with a higher concentration of elastin and muscle fibers
– Cutting Balloon™ atherotomes score through fibrotic plaque providing a novel and simple strategy for coronary lesions resistant to conventional balloon dilatation¹⁰

References

* Compared to Cutting Balloon™ Ultra² ™, internal bench testing and cadaver testing conducted by Boston Scientific Corporation. Data on file. N=3, 3.0mm x 15mm. Bench test results may not necessarily be indicative of clinical performance.
**As known to date on the market
1. Bonan, J Invasic Cardiol, 1999;11:230
2. Hara et al. AM. J Cardiol 2002;89:1253-1256
3. Ergene et al, J Invasic Cardiol 1998;10:70-75
4. Yamaguchi et al. J Interven Cardiol 1998; 11(Suppl) S114-S119
5. Suzuki et al. Amer J Cardiol 1999; 84 Suppl;58P ( US SCI#201-206 )
6. Kurbaan et al, Cutting Balloon Angioplasty for In-Stent Restenosis, Catheterization and Cardiovascular Interventions 50:480-483 (2000)
7. Alfonso F., Should we use the Cutting Balloon in Patients With In-Stent Restenosis?, JACC Vol 44, No 12, 2004, Dec 21, 2004:2410-9
8. Taniuchi et al. The WINNER registry, Catheter Cardiovasc Interv 2004;62C-36
9. Inoue et al. J Interven Caridol. 2003;13:7-14
10. Bertrand et Al, Mgt of Resistant Coronary Lesions by the Cutting Balloon Catheter, Catheterization and Cardiovascular Diagnosis, 41:179-184 (1997)