We at Medgadget.com routinely straddle that fine line between medical device and sex toy, spending countless hours debating what new products are fit for display to our educated, hospital-based audience — and what’s better left unsaid.
We’re giving the benefit of the doubt to Futura’s FLD500 condom, which at least will be registered in the EU as a Class III Medical Device (we think this is roughly analagous to the “NC-17” movie rating in the US). The FLD500 is completing “clinical trials”:
Futura Medical PLC, the pharmaceutical and medical device group that develops innovative products for the sexual health market, said it is to start pilot scale-up trials of its Female Lubrication Device (FLD500) ahead of dossier submission for the product’s regulatory approval…
FLD500 is a standard Durex ‘easy on’ condom with a thin elastomer coating containing an active compound on the outer surface to promote greater natural lubrication and heightened pleasure for women.
Hehe… they said “scale up”. Ahem. Ok, we were curious about this elastomer but the Futura website is being tight-lipped about it:
…Application of the compound to the subjects was found to be safe and well tolerated at the lower-strength doses, with no adverse events experienced during the twelve exposures. Subjects receiving the higher-strength doses reported dose-related adverse events, predominately headaches, ranging from mild to severe in intensity. No clinically significant changes in blood pressure, haematology or biochemistry profiles were seen in any Subjects at any of the dose levels.
Efficacy was assessed by monitoring vaginal microcirculation using photoplethysmography. Positive responses were more frequent in the group receiving the lower-strength doses, where the compound was also considered safe and well tolerated. The pattern of changes observed mimic the blood flow changes seen in women during clitoral stimulation and sexual arousal.
Following a review of all the clinical data by Futura’s panel of consultants and supported by preliminary feedback from the EU competent authority no further clinical work is planned prior to the submission of the dossier for FLD500 for regulatory approval in the European Union.
More from Futura Medical…
