Product.Viveca Biomed is the manufacturer of Contrelle Activgard. A comfortable, discreet, easy to use bladder support, designed to reduce or stop bladder leaks caused by Stress Urinary Incontinence (SUI).
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A revolutionary new solution for bladder leaksContrelle Activgard is a bladder support for the treatment of female stress incontinence, and mixed incontinence where stress is prevalent. Women more commonly refer to this as bladder leakage. The product is manufactured from a unique biocompatible foam and is as easy to insert as a tampon, though it works very differently. Contrelle Activgard gently supports the bladder neck, helps to improve the angle of the bladder, provides gentle pressure on the urethra and stops bladder mobility. Contrelle actively works with the body.
In simple terms, Contrelle can stop bladder leakage immediately making major improvements in quality of life, freeing women from having to use pads and liners, and in most cases enabling women to exercise without any leakage. Contrelle Activgard can get women back onto the trampoline in 3 minutes…the time to take out of the pack and insert. |
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Millions of women suffer worldwideBladder leakage affects 1 in 3 women at some point in their lives. Research has highlighted the negative impact of the condition on sufferers mental and physical health. A recent study found 41% felt anxious and depressed, whilst 22% had modified their exercise routine and 19% had given up exercise altogether. Contrelle Activgard offers these women a solution and an opportunity to live life the way they want to.
Contrelle’s estimated potential market size, based on 38 epidemiological studies: UK: 5 million Europe: 20 million North America: 20 million |
A wealth of clinical evidenceThe success of Contrelle Activgard is clinically evidenced by seven clinical trials to date, all with statistical significance. Data demonstrates high levels of efficacy, with long term (12 month) data showing 94% of women report an improvement in symptoms. Clinical data reports significant reduction in pad usage/ volume of leakage, with significant improvement across objective scores and major improvement in quality of life.
Additionally, Scandinavian women have been using Contrelle® for over 10 years, with approaching 6 million devices used globally to date. There have been no reports of any issues with Toxic Shock Syndrome. Clinical data shows no pH changes or effect on vaginal flora. |
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The Contrelle product rangeContrelle comes in three sizes to allow women to find the most effective and comfortable fit. The Sizing Kit contains all three sizes.
Size 1- Small Size 2- Medium Size 3- Large We recommend women start with the sizing kit. Once women establish the best size for them, 5-packs and 30-packs are available in each size. |
Device Classification and Regulatory Approvals
Medical Device Class IIa
Contrelle Activgard is a medical device which conforms with the Essential Requirements of the Medical Device Directive - 93/42/EEC of June 14, 1993 as amended by Directive 2007/47/EC of 21st September 2007. It is designed and manufactured by Viveca Biomed Limited, in accordance with the scope of a quality system which meets the requirements of ISO 13485:2016 and the Medical Devices Directive - 93/42/EEC.
The Notified Body is (No. 1282) ENTE Certificazione Macchine SRL (ECM), Via Ca’ Bella, 243/A – loc. Castello di Serravalle 40053 Valsamoggia (BO) Italy who have approved the manufacturing full quality assurance system.
CS Life Sciences Europe Ltd, 3 Inns Quay, Dublin 7, Ireland has been appointed to act for Viveca Biomed Ltd within the European Union as their Authorised Representative.
GMDN code 61853
EUDAMED Registration No. SRN GB-MF 000012584
Contrelle Activgard is a medical device which conforms with the Essential Requirements of the Medical Device Directive - 93/42/EEC of June 14, 1993 as amended by Directive 2007/47/EC of 21st September 2007. It is designed and manufactured by Viveca Biomed Limited, in accordance with the scope of a quality system which meets the requirements of ISO 13485:2016 and the Medical Devices Directive - 93/42/EEC.
The Notified Body is (No. 1282) ENTE Certificazione Macchine SRL (ECM), Via Ca’ Bella, 243/A – loc. Castello di Serravalle 40053 Valsamoggia (BO) Italy who have approved the manufacturing full quality assurance system.
CS Life Sciences Europe Ltd, 3 Inns Quay, Dublin 7, Ireland has been appointed to act for Viveca Biomed Ltd within the European Union as their Authorised Representative.
GMDN code 61853
EUDAMED Registration No. SRN GB-MF 000012584
