Rigi10™: A Clinical Evidence Summary

Rigicon's Rigi10™ is a new-generation malleable (semi-rigid) penile prosthesis. It uses Flexible Rod Technology™ built on a stainless-steel core with titanium caps, allowing bending angles up to 135 degrees while maintaining shape across repeated use.

• Available diameters: 9, 10, 11, 12, 13, and 14 mm.
• Lengths: 23 cm for the 9 and 10 mm diameters, and 25 cm for the 11 to 14 mm diameters.
• SecureFit™ Rear Tip Extenders for length adjustment to anatomy.
• HydroShield™ hydrophilic coating supporting infection-prevention protocols via antimicrobial-solution soaking.

A series published in IJIR (2024) followed 605 first-time Rigi10™ recipients and reported a 0.99% surgical revision rate, zero mechanical failures, and a 99.2% device survival at three years. These figures are attributed to their published source and should be reconciled against the full article before any regulated campaign.

A published multicenter study additionally supports the performance profile of the new-generation malleable implant across varied clinical samples. Outcome detail remains for review within each patient context.

Rigi10™ received FDA 510(k) clearance, K181673, dated 15 April 2019, with a decision of "Substantially Equivalent." The phrasing "FDA 510(k) cleared" is used exclusively, not "FDA approved." Rigicon® is American in origin; study locations are research sites, not the brand's origin.

The malleable Rigi10™ complements the inflatable Infla10® Pulse™ within Rigicon's reconstructive-urology portfolio. The choice between the two remains a decision the surgeon builds on dexterity, anatomy, prior surgeries, and patient expectations.

Rigi10™ is available in Iraq through ALZIEBAQ Scientific Bureau, the authorized exclusive distributor for Rigicon®. For the IFU, the 510(k) summary, or a sizing-kit demonstration at the clinic, physicians may contact the Bureau. Please confirm local availability and final specifications before publication.