The PrePex™ device
Developed in 2009/10 by Fuerst, Kilemnick & Shohat and marketed by a company called Circ MedTech Limited, this device is specifically aimed at the sub-Saharan market in Africa and is designed for use in non-sterile environments by minimally trained healthcare professionals. Possibly uniquely for modern clamps, it is suitable for routine use without anaesthesia. In common with many fit-&-wear clamps, it requires no sutures.
Circ MedTech is an ad-hoc private company incorporated in the British Virgin Islands. The CEO is Tzameret Fuerst; prior to the formation of Circ MedTech she was the Director of New Product Development at Keter Plastic (an Israeli company that is one of the world’s largest plastics manufacturers) and was a Strategic Planner at the advertising agency Geller-Nessis.
Circ MedTech is an ad-hoc private company incorporated in the British Virgin Islands. The CEO is Tzameret Fuerst; prior to the formation of Circ MedTech she was the Director of New Product Development at Keter Plastic (an Israeli company that is one of the world’s largest plastics manufacturers) and was a Strategic Planner at the advertising agency Geller-Nessis.
 |
Procedure: Something akin to an industrial grade 'O'-Ring is used to induce ischemic necrosis. Unsprung from the “placement ring”, the 'O'-Ring engages with a groove in the inner ring that has been pre-positioned under the foreskin. For several days, the wearer walks around with only the 'O'-Ring visible; the applicator has by then been removed. The foreskin dies off and, when it has, the device is removed by flicking the 'O'-Ring out of the groove of the component that is still out of sight, hidden in the sulcus.
Early criticism of the PrePex device suggested that a significant amount of inner foreskin would remain after circumcision, resulting in a failure to remove as many Langerhans cells as other methods. However, confidential images seen by Circlist show that the finalised design can produce a ‘low’ style if the device is correctly used.
The first results of Safety & Efficacy Trials appeared in the online version of JAIDS, the Journal of Acquired Immune Deficiency Syndromes, on 08.Sep.2011.
“Ramping Up” of numbers involved in the campaign of medical male circumcision in Rwanda, using the PrePex system, is described in an article published by Plus News on 9th January 2012. Also in January 2012, PrePex achieved the coveted FDA accreditation, opening the way for marketing in many countries that use the US yardstick as their determinant of medical device approval. In April 2012, PrePex won the Best Technology for Health Award and has also found favour with WHO’s Technical Advisory Group on Innovations in Male Circumcision. (See our news report dated 17.May.2012).
A video illustrating the PrePex procedure is now available on the company’s website.
Early criticism of the PrePex device suggested that a significant amount of inner foreskin would remain after circumcision, resulting in a failure to remove as many Langerhans cells as other methods. However, confidential images seen by Circlist show that the finalised design can produce a ‘low’ style if the device is correctly used.
The first results of Safety & Efficacy Trials appeared in the online version of JAIDS, the Journal of Acquired Immune Deficiency Syndromes, on 08.Sep.2011.
“Ramping Up” of numbers involved in the campaign of medical male circumcision in Rwanda, using the PrePex system, is described in an article published by Plus News on 9th January 2012. Also in January 2012, PrePex achieved the coveted FDA accreditation, opening the way for marketing in many countries that use the US yardstick as their determinant of medical device approval. In April 2012, PrePex won the Best Technology for Health Award and has also found favour with WHO’s Technical Advisory Group on Innovations in Male Circumcision. (See our news report dated 17.May.2012).
A video illustrating the PrePex procedure is now available on the company’s website.
Questions and Answers about the PrePex device
Here are some questions raised in "Letters to the Editor" along with the answers given by Circ MedTech’s CEO:
- Q: Why did Circ MedTech use military personnel as test subjects? They are not fully representative of the general population in several respects: Fitness, pain tolerance, diet, hygiene régimes, environmental factors that have infection control implications....
A: Only 5 patients out of 100 in the safety study were soldiers. In the comparison study currently underway (clinicaltrials.gov ID NCT01284088), all patients are civilians. Kanombe is a military and district hospital. The promising results of the Rwandan Government study will be public information very soon in prestigious conferences, in medical journals and on the circlist.com website. - Q: Is it really the case that the foreskin is NOT at first severed in a PrePex circumcision, but left intact for a week to necrotise 'in situ'?
A: Yes, it is true. The device is left in situ for 7 days, until the foreskin is fully necrotized. This is part of what makes the patent pending device and method safe and simple to use, with very little training (you don’t even have to be a nurse). This also enables a bloodless procedure (no cutting of live tissue!), a critical factor in rural settings. There is no anesthesia (so no needles!), no blood, no sutures and no sterile settings required, as the device comes in contact only with intact skin. There were no infections or complications throughout the whole study from anyone while the device was in situ, confirming the safety of the technique. From discussions with patients after the study, one of the key benefits raised was that the procedure had no blood. - Q: Adults only, or child sizes too?
A: For now, only adult sizes are readily available, but we will have child sizes too.
Tidak ada komentar:
Posting Komentar