#Paris #France #Colorectal Surgery #Colovac® #SafeHeal®

SafeHeal® Launches Pivotal Study for Colovac® Device

SafeHeal®, an innovative leader in colorectal cancer surgery solutions, has embarked on an exciting journey with the initiation of its groundbreaking SAFE-3CV study. This pivotal investigation aims to assess the efficacy of the Colovac® device, a flexible endoluminal bypass sheath designed to replace temporary diverting ostomy procedures for patients undergoing colorectal resection. The significance of the Colovac® device cannot be overstated, as it promises to transform the postoperative experience for countless individuals and reduce the complications associated with traditional ostomy procedures.

Enrollment and Study Details

On January 13, 2026, SafeHeal® proudly announced the first patient enrollment at the Hôpital Saint-Antoine in Paris, under the guidance of renowned Principal Investigators—Patricia Sylla, MD, in the U.S. and Prof. Jérémie Lefevre in the EU. The SAFE-3CV study will span approximately 20 sites across the U.S. and Europe, targeting a total of 252 patients. This two-phase study not only serves as a key step towards obtaining U.S. market approval but also aims to provide robust post-market surveillance data within the European Union. Through this comprehensive approach, the study seeks to evaluate the safety and efficacy of Colovac® in comparison to previously established control data from patients who underwent standard diverting ostomy procedures.

The Need for Change

The current standard care for rectal cancer involves using a diverting ostomy, a procedure that diverts stool from the surgical site to an external ostomy bag. This solution, although commonly accepted, presents many challenges. Patients face significant physical complications, lifestyle limitations, and extended recovery periods due to the presence of an ostomy. Many individuals feel socially isolated and struggle with issues relating to intimacy, further impacting their quality of life. In some cases, ostomies can become permanent, introducing even more factors that contribute to patient distress.

With the Colovac® device, SafeHeal® aims to alleviate these challenges. By providing a less-invasive alternative to traditional ostomy procedures, the Colovac® device seeks to eliminate the array of complications associated with stoma management, improving recovery times, quality of life, and overall patient experience.

Clinical Experience

Prof. Jérémie Lefevre, serving as the Principal Investigator in Europe, has a wealth of experience with the Colovac® device, having co-led previous studies that demonstrated its favorable safety and efficacy profiles. His confidence in this innovative solution stems from comprehensive clinical trials conducted across multiple regions, including the U.S., Europe, and Asia. In August 2025, the device received approval for market release in the European Union under the new Medical Device Regulation, marking a significant advancement in medical technology.

Looking Ahead

“We believe that the arrival of Colovac® will reshape the future of colorectal surgery,” notes Chris Richardson, President and CEO of SafeHeal®. “Collaborating with esteemed clinicians such as Prof. Lefevre and Dr. Sylla is pivotal as we build on our existing body of evidence and move towards FDA marketing approval for Colovac®.” The successful completion of the SAFE-3CV study will be the final milestone on the route to commercialization in the United States, where the device currently holds FDA Breakthrough Device designation. This status expedites the review process for new technologies that significantly impact patients suffering from serious medical conditions.

About SafeHeal®

Founded in Paris, France, SafeHeal® represents an evolution in medical device innovation. Focused on enhancing surgical outcomes for colorectal patients, the company’s flagship product, Colovac®, exemplifies its commitment to patient-centric solutions. Designed for safety and ease of use, the Colovac® device not only aids in the healing process but allows patients to reclaim their lives without the burden of an ostomy. As the study progresses, the SafeHeal® team remains dedicated to bringing this revolutionary technology to the U.S. market, where it will fulfill the pressing need for improved postoperative care.

For further information about SafeHeal® and the Colovac® device, please visit www.safeheal.com.