About EBONY PTA 

Performance and Versatility Within reach

Technical Specifications

• Ebony is available in different balloon diameters: 0.014" OTW, 0.018" OTW, and 0.035" OTW.
• Ebony balloon material is made of Pebax.
• Ebony balloon diameter ranges from 1.5 to 4.0 mm for 0.014" OTW, 2.0 to 7.0 mm for 0.018" OTW, and 3.0 to 12.0 mm for 0.035" OTW.
• Ebony balloon length ranges from 10 to 200 mm for 0.014" RX, 20 to 200 mm for 0.014" OTW, 40 to 200 mm for 0.018" OTW, and 20 to 200 mm for 0.035" OTW.
• Ebony usable shaft length varies from 80 cm, 130 cm, and 150 cm for 0.035" OTW.
• Ebony tip entry profile is less than 0.60 mm for 0.014" OTW, and 0.018" OTW, and less than 1.10 mm for 0.035" OTW.
• Ebony has a Proglide coating and 3 year expiration
• Ebony nominal pressure ranges from 6 to 8 atm  0.014" OTW, and 0.018" OTW, and 5 to 8 atm for 0.035" OTW.
• Ebony rated burst pressure ranges from 12 to 16 atm for 0.014" OTW and 0.018" OTW, and 10 to 14 atm for 0.035" OTW.
• Ebony average burst pressure ranges from 16 to 20 atm for 0.014" OTW and 0.018" OTW, and 14 to 18 atm for 0.035" OTW.

Size Matrix, Guiding Catheter & Sheath compatibility

• Ebony is compatible with different guiding catheter sizes and introducer sheath sizes depending on the balloon diameter.
• Ebony compatibility information is provided in tables for each balloon diameter.

Dilation of lesions

• Ebony is intended for the dilation of lesions in various arteries, including iliac, femoral, popliteal, infrapopliteal, and renal arteries.
• Ebony is also indicated for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

 

*Refer to the Instructions for Use for a complete listing of the indications, contraindications, warnings and precautions. Information in this material is not a substitute for the product Instructions for Use.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.