Cervical cancer and precancerous cervical changes remain a significant global health concern, requiring improved screening and treatment strategies. The current standard procedure, large loop excision of the transformation zone (LEEP) or cone biopsy, has known limitations.

To address these challenges, Dr. Dirk Coeman developed a novel approach: Vacuum-Assisted Loop Excisional Biopsy (Valéb). Valéb is an investigational medical device designed as a minimally invasive alternative to existing procedures. It is currently under development and has not yet received regulatory approval for clinical use. Valéb and associated technologies are patent protected.

The device features a cup-shaped design that uses vacuum-assisted aspiration to stabilize the cervix. A rotating electrical wire within the cup is intended to allow for controlled tissue excision, while the enclosed environment helps eliminate surgical smoke exposure, an important consideration for provider and patient safety and comfort.

Valéb is being developed with the goal of reducing the excised volume of healthy cervical tissue, while maintaining treatment accuracy. Its adjustable excision depth is designed to allow for a tailored approach. The device is intended for use by trained healthcare providers in both high-income and low- to middle-income countries, with potential to support broader access to care.

To evaluate Valéb’s safety, feasibility, and potential clinical utility, comprehensive clinical trials are planned. Currently the FDA clearance process is being prepared. Studies will aim to assess outcomes, compare performance with standard techniques, and explore its broader impact on cervical cancer prevention.

By addressing limitations of current procedures, Valéb represents an innovative approach in the field of cervical dysplasia treatment. Continued research and clinical validation will be essential to determine its effectiveness and potential role in improving women’s health globally.