Prepex Circumcision Device

Product Description

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.

Market Suggested Retail Price

$45.00

Distributors / Implementing Organizations

Circ MedTech Ltd distributes the Prepex device to health clinics and hospitals.

Manufacturing/Building Method

The Prepex device is mass produced by Circ MedTech, Ltd.

Intellectural Property Type

Patent Protected

User Provision Model

This device is available in health clinics and hospitals for use by surgically trained nurses and/or minimally skilled healthcare workers.

Distributions to Date Status

In 2011, Prepex and the Rwandan Military hospital successfully tested the device and 10,000 procedures were performed.

Age Requirement

18+

Infection Rate (%)

Unknown.

Injection of local anesthesia required (Y/N)

Number of visits per procedure

Procedure Time (“skin to skin”)

2.5-3 minutes (Placement and Removal)

Design Specifications

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.

Technical Support

Healthcare professionals are trained over a period of 3 days to 2 weeks. A Prepex training program is available to physicians.

Replacement Components

None

Lifecycle

The components are created for single use and disposal.

Manufacturer Specified Performance Parameters

The PrePex device enables non-surgical adult male circumcision.

Vetted Performance Status

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.

Safety

This device is made for single use and disposal. The PrePex device should not be used in cases of phimosis or congenital abnormality.

Complementary Technical Systems

None

Academic Research and References

Bitega JP, Ngeruka ML, Hategekimana T, Asiimwe A, Binagwaho A. Safety and Efficacy of the PrePex Device for Rapid Scale-Up of Male Circumcision for HIV Prevention in Resource-Limited Settings. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2011;58(5). doi:10.1097/qai.0b013e3182354e65

Mutabazi V, Kaplan S, Rwamasirabo E, Bitega JP, Ngeruka ML. Male Circumcision Comparison Between a Nonsurgical Device to a Surgical Technique. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2012;61(1):49–55.

Duffy K, Galukande M, Wooding N, Dea M, Coutinho A. Reach and Cost-Effectiveness of the PrePex Device for Safe Male Circumcision in Uganda. PLoS ONE. 2013;8(5). doi:10.1371/journal.pone.0063134

Galukande M, Duffy K, Bitega JP, Rackara S, Bbaale DS, Nakaggwa F, Nagaddya T, Wooding N, Dea M, Coutinho A. Adverse Events Profile of PrePex a Non-Surgical Device for Adult Male Circumcision in a Ugandan Urban Setting. PLoS ONE. 2014;9(1). doi:10.1371/journal.pone.0086631

Tshimanga M, Hatzold K, Mugurungi O, Mangwiro T, Ncube G, Xaba S, Chatikobo P, Gundidza P, Samkange C, Dhlamini R, et al. Safety Profile of PrePex Male Circumcision Device and Client Satisfaction With Adolescent Males Aged 13–17 Years in Zimbabwe. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2016;72. doi:10.1097/qai.0000000000000799

Kigozi G, Musoke R, Watya S, Kighoma N, Nkale J, Nakafeero M, Namuguzi D, Serwada D, Nalugoda F, Sewankambo N, et al. The Safety and Acceptance of the PrePex Device for Non-Surgical Adult Male Circumcision in Rakai, Uganda. A Non-Randomized Observational Study. PLoS ONE. 2014;9(8). doi:10.1371/journal.pone.0100008

Compliance with regulations

PrePex is WHO prequalified, FDA cleared and certified CE Mark Class IIa. Circ MedTech is ISO 13485 certified.

Other Information

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.