#United States #Los Angeles #Aspivix #cervical stabilizer #carevix

Aspivix Sets New Standards in Gynecological Care

In a significant advancement for gynecological medicine, Aspivix, a pioneering FemTech company, has recently announced the peer-reviewed publication of its multicenter post-marketing study results in the highly esteemed International Journal of Gynecology & Obstetrics. The study focuses on the safety and efficacy of carevix®, a suction-based cervical stabilizer designed specifically for intrauterine device (IUD) insertion. This innovative device challenges the traditional usage of the sharp-toothed tenaculum, which has been the decades-old standard in gynecological procedures.

A Breakthrough in Device Technology

carevix® stands out as the world's first clinically validated suction cervical stabilizer, carefully engineered to gently grasp and maintain the cervix during IUD insertions and various transcervical procedures. Notably, this device allows for effortless tissue release at the push of a button, marking a significant shift in the approach to gynecological care.

The overarching goal of this multicenter study was to evaluate the device's performance across 1,123 IUD procedures conducted at 19 diverse sites in countries including the USA, Brazil, and multiple European nations. Involving trained healthcare professionals, the study ensured a comprehensive analysis of operational safety and patient satisfaction.

Key Findings of the Multicenter Study

The data garnered from the study highlighted remarkable patient feedback and healthcare professional satisfaction:

• - 94% of participants expressed overall satisfaction with carevix®.
• - 81% stated that they would recommend the procedure for its ease and manageable pain levels.
• - An impressive 82% of healthcare providers endorsed their experience in using carevix®, citing ease of use and visibility as major benefits.
• - Approximately 73% of participants found the procedure to be less painful than anticipated.

These findings underscore the device's potential to improve the gynecological experience significantly, which has long been plagued by discomfort and anxiety during such procedures.

Industry Recognition and Future Directions

Mathieu Horras, CEO of Aspivix, commented on the implications of the study, stating, "The findings highlighted in this renowned publication reinforce the positive reception carevix® has had from clinicians and patients alike. We are committed to transforming gynecological care, and this strong clinical evidence supports our growing commercial opportunities in the US and beyond."

This study builds upon a foundation of prior controlled trials conducted within Switzerland and contributes to a growing body of evidence that prioritizes patient comfort and safety. Notably, carevix® has received critical accolades, including FDA clearance and recognition as one of TIME magazine's Best Inventions of 2024.

Dr. Alissa M. Conklin, an assistant professor of Clinical Obstetrics and Gynecology at Indiana University School of Medicine, emphasized the importance of pain management in patient experience during medical procedures. "An effective, user-friendly device that enhances patient comfort is a monumental advancement in patient care," she stated.

Ikram Guerd, Aspivix's General Manager in the US, pointed out the cultural shift this device represents, stating, "Patients no longer need to endure unnecessary pain and discomfort during routine gynecological procedures. Carevix® offers a gentler solution for women and individuals with a uterus."

As the medical community observes these advancements in women's healthcare, the launch of carevix® is poised to transform both professional practices and patient experiences. Aspivix's mission to continue innovating within the FemTech space aims at empowering women and enhancing the standards of gynecological care.

For more detailed results from the multicenter study, interested parties may visit Aspivix's official website at www.aspivix.com.

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This innovative device also demonstrates how technology can revolutionize healthcare practices, leading to less invasive and more comfortable procedural experiences for women everywhere.