SafeHeal®, a leading company in innovation for colorectal cancer surgery, has recently obtained marketing authorization from the European Union for its Colovac device, in accordance with the new Medical Device Regulation (EU MDR 2017/745). This significant advancement will allow for the distribution of Colovac in major EU markets, ensuring compliance with the strict safety and efficacy standards set by the regulatory authority.
Chris Richardson, President and CEO of SafeHeal, celebrated this achievement and highlighted the dedication of the clinical and engineering teams. Colovac emerges as a less invasive alternative to temporary ostomy, a procedure commonly performed following colorectal cancer resection. An ostomy diverts waste to the outside of the body to facilitate healing of the anastomosis and may require a second surgery, prolong recovery time, and carry risks of complications.
The Colovac device aims to eliminate the need for a temporary stoma, thereby improving patients’ quality of life by reducing the complications and risks associated with ostomy. “Navigating the MDR process is complex, and this approval validates the robustness of our technology and the strength of our data,” commented Richardson.
Colovac has been tested in various regions, including the United States and Europe, where it has received the designation of innovative device from the U.S. Food and Drug Administration (FDA), which has expedited its review due to its potential to improve patients’ lives.
In conclusion, the entry of Colovac into the European market promises to revolutionize the treatment of patients with colorectal cancer by offering a less invasive option to address post-surgical complications. SafeHeal remains committed to innovating and enhancing the well-being of patients facing complex conditions.
Referrer: MiMub in Spanish