Prepex Circumcision Device
The Prepex Circumcision Device is a medical device which facilitates non-surgical adult male circumcision without the use of anesthesia, surgery, suturing or sterile setting. It is designed to improve and advance the circumcision experience for the patient and the related ecosystem, in order to achieve rapid scale-up of voluntary medical male circumcision (VMMC) in resource limited settings and reduce transmission of HIV/AIDS and other infectious diseases.
Target regions include geographic areas with high prevalence of heterosexually transmitted HIV and low prevalence of male circumcision in Sub-Saharan Africa. Specifically, PrePex is being used in 13 priority countries in Sub-Saharan Africa as of Feb. 2014 Botswana, Kenya, Lesotho, Malawi, Mozambique, Namibia, Rwanda, South Africa, Swaziland, Tanzania, Uganda, Zambia, Zimbabwe
Circ MedTech Ltd distributes the Prepex device to health clinics and hospitals.
Surgical circumcision methods, ShangRing, AlisKlamp, SmartKlamp, TaraKlamp, IsmailKlamp, Zhenxi Ring
Intended for use by trained surgical nurses and/or minimally skilled healthcare workers.
This device is available in health clinics and hospitals for use by surgically trained nurses and/or minimally skilled healthcare workers.
In 2011, Rwanda successfully tested the device and 10,000 procedures were performed.
The Prepex Circumcision Device consists of an inner ring, elastic ring, placement ring, and a verification thread; there is also a sizing accessory, a template with 5 holes of differing size to guide the selection of ring size. The device works by compressing the foreskin so as to cut off circulation distally, after which the distal foreskin becomes necrotic, allowing easy and bloodless removal.
The components are created for single use and disposal.
The PrePex device enables non-surgical adult male circumcision.
Mean time to complete healing was 25.3 days after foreskin removal or 32 days after device placement. The PrePex device was safe and effective as a means of performing bloodless adult male circumcision that can be carried out by nonphysician staff without need for anesthesia, suturing, or sterile settings. The mean PrePex skin-to-skin procedure time is 3.1 minutes. 91 of 92 patients (99%) in the PrePex group were satisfied with the aesthetics of circumcision. Ninety-one of 92 (99%) patients in the PrePex group would recommend the procedure.
This device is made for single use and disposal. The PrePex device should not be used in cases of phimosis or congenital abnormality.
Auvert B, et al. Randomized, Controlled Intervention Trial of Male Circumcision for Reduction of HIV Infection Risk: The ANRS 1265 Trial (2005) PLoS Med 2(11): e298. doi: 10.1371/journal.pmed.0020298
Robert C Bailey et.al., Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial: Volume 369, No. 9562, p643–656, 24 February 2007
PrePex is WHO prequalified, FDA cleared and certified CE Mark Class IIa. Circ MedTech is ISO 13485 certified.
Randomized, Controlled Intervention Trials, Government-sponsored studies. User feedback, healing time, skin-to-skin procedure time.
As of February 2014 PrePex is being used exclusively in 13 priority countries in Sub-Saharan Africa with high HIV prevalence and consequently the device is not yet available elsewhere.
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