Modified PrePex D0FRP Procedure Receives CE Mark Approval
A modification to the PrePex Procedure — foreskin removal shortly after device placement (D0FRP) — has received the CE mark approval, which validates the safety and efficacy of the modified technique. The modification facilitates use of PrePex with equal tetanus mitigation to that of surgical circumcision, per the latest World Health Organization guidelines on the matter. The PrePex procedure now offers even more advantages to clients opting for Voluntary Medical Male Circumcision (VMMC) than ever before, including minimal discomfort, no recovery days and minimal pain.
A Clinical Study, which included 500 men, validated the safety and efficacy of the PrePex D0FRP. The study results, which validated with statistical significance that D0FRP is safe, were reviewed and approved by the CE mark notified body. The study report was submitted for review of the World Health Organization for Pre-Qualification to allow VMMC programs the immediate use of the modified PrePex D0FRP technique.