ConTIPI Medical launches pelvic organ prolapse device 'ProVate' in US

ConTIPI partnered with EVERSANA as commercialisation partner

ConTIPI Medical, a provider of non-surgical and disposable solutions for women with various pelvic floor dysfunctions, has announced the launch of its device ‘ProVate’, specifically designed to help women experiencing pelvic organ prolapse (POP).

POP occurs when weakness of the pelvic support system causes various surrounding organs to prolapse into the vaginal cavity. Symptoms might include bulging from the vagina, difficulty emptying bowels, through to discomfort and pain. The most commonly reported figure is that ~3.5 million USA women (range 1.36-5.33) currently suffer from symptomatic POP. This figure equates to ~2.9% of the US female population over the age of 30, and is expected to rise 46% to 4.9 million by 2050.

Most women with POP only require a non-invasive way to manage symptoms. But existing pessaries are associated with a high drop-off rate for use, and reusable devices tend to be difficult for most users to insert and remove.

Instead, the ProVate Device is ready-to-use at home and it is disposable. It is inserted into the vagina through a disposable applicator, in a similar way to how a menstrual tampon applicator works. Once in place the plunger of the applicator is depressed and the device becomes fully deployed allowing it to expand to its full size in place. The device is available in six sizes and may be used for up to seven days. It also may be removed at any time prior, with just a pull on a string, for disposal. All of these features mean that women can take control of their symptoms, easily and effectively within the comfort and privacy of their own home.

The ProVate Device is now available for physicians across the US to prescribe and has been launched with commercialisation partner EVERSANA.

Dr. Elan Ziv, MD, OBGYN, Urogynecologist, CEO & Medical Director with ConTIPI Medical said:

"Today marks a significant milestone in women's health in the United States as we are thrilled to see that ProVate is now available for physicians to prescribe for patients with pelvic organ prolapse."

"EVERSANA has been a tremendous partner throughout the commercialization process, and we look forward to continued work with their best-in-class team."

ConTIPI Medical’s ProVate Device, for the non-surgical management of Pelvic Organ Prolapse (POP) has a 510(k) clearance from FDA for marketing in the United States, and a CE Mark for marketing in the EU.