Collaboration to advance market launch of ProVate device for pelvic organ prolapse

ConTIPI Medical has announced a partnership with EVERSANA to support the US commercial launch of the ProVate device, a vaginal ring pessary for patients with pelvic organ prolapse (POP), according to a news release from EVERSANA.¹

The safety and efficacy of the ProVATE device were evaluated in a prospective, multicenter, home-use study.

ProVate has been granted a 510(k) clearance from the FDA and has obtained a CE Mark for marketing in Europe. The company expects the device to become available for US patients with POP in September 2024.

"We've found that it is critical that a commercialization partner understands our mission and vision and has proven success in navigating the complexity of product commercialization and patient adoption," said Elan Ziv, MD, an OBGYN, urogynecologist, CEO, and medical director for ConTIPI Medical, in the news release.¹ "EVERSANA checks all the boxes, and we look forward to a long and prosperous partnership to bring this new therapy to women in need."

The safety and efficacy of the ProVATE device were evaluated in a prospective, multicenter, home-use, pilot study (NCT02239133) published in BMC Womens Health.²

Overall, the study demonstrated the efficacy of the device in reducing prolapse, with all patients in the study experienced a reduction of at least 2 stages according to the Pelvic Organ Prolapse Quantification (POP-Q) scale. In addition, 97.8% of patients experienced a complete reduction to stage 0 according to the POP-Q scale.

A significant improvement in subjective efficacy according to the POP symptom alleviation questionnaire was also observed (P < .0001). Data also showed significant improvements in both the modified Pelvic Floor Impact (PFIQ-7) and Pelvic Floor Disability Index (PFDI-20) questionnaires (P < .0001 for both).

Regarding safety, 91 nonserious device-related adverse events (AEs) were reported. Of these, 98.9% were mild and 87.9% were anticipated. No patients experienced vaginal infection and there was 1 case of urinary tract infection.

In total, the study included 52 patients who underwent 94 total usage cycles across 3558 days. Among all patients, 24 participants completed 1 usage cycle, 14 completed 2 usage cycles, and 14 completed 3 usage cycles. Each usage cycle included 28 to 45 days of ProVate use.

The average age of participants was approximately 60 years. Among all patients, 81.1% were postmenopausal.

The primary efficacy end point for the study was the proportion of patients with improved staging on the POP-Q scale.

Overall, the authors concluded, “The novel device substantially reduces prolapse and provides significant subjective POP symptom relief and QoL improvement, with minimal AEs. The device may enable women to self-manage their prolapse with a small, disposable device that minimizes self-touching and frequent dependency on the clinic.”²

References

1. ConTIPI Medical selects EVERSANA to support US commercialization of non-surgical medical device ProVate for women with pelvic organ prolapse. News release. EVERSANA. August 27, 2024. Accessed September 6, 2024. https://www.prnewswire.com/news-releases/contipi-medical-selects-eversana-to-support-us-commercialization-of-non-surgical-medical-device-provate-for-women-with-pelvic-organ-prolapse-302231139.html

2. Ziv E, Erlich T. Novel, disposable, self-inserted, vaginal device for the non-surgical management of pelvic organ prolapse: efficacy, safety, and quality of life. BMC Womens Health. 2022;22(1):459. doi:10.1186/s12905-022-02057-6