CE Mark Approval for the HYDRAFIL System: A Promising Advancement in Chronic Low Back Pain Treatment
Medical device company ReGelTec obtains CE Mark for its HYDRAFIL System
The HYDRAFIL System, developed by ReGelTec, has achieved a significant milestone with the receipt of CE Mark under the new European Union Medical Device Regulations. This approval signifies that the system meets the stringent health, safety, and environmental protection standards set by the European Union, making it eligible for use in treating chronic low back pain due to degenerative disc disease.
Regulatory Requirements
To secure the CE Mark, the HYDRAFIL System had to meet the rigorous requirements outlined in the EU MDR (Medical Device Regulation). As a Class III device, it underwent extensive testing and evaluation, including clinical trials, to ensure its safety and effectiveness.
Treatment Implications
The HYDRAFIL System offers a minimally invasive treatment option for patients suffering from chronic low back pain due to degenerative disc disease. This approach can significantly reduce recovery time and minimize complications compared to more invasive procedures.
The system works by injecting a viscous fluid that solidifies into a cohesive hydrogel within the disc annulus, effectively sealing the access site and minimizing the risk of expulsion. This technique aids in disc augmentation while preserving spinal motion.
Clinical Trials and Future Developments
Following promising results from 75 patients treated outside the United States, the HYDRAFIL-D study has been initiated. This study, currently enrolling patients at eight sites in the U.S., is intended to support U.S. regulatory approval for the HYDRAFIL System.
The HYDRAFIL technology has been granted patents in Europe and the U.S., ensuring intellectual property protection until 2040. The CE Mark approval and ongoing clinical trials are steps toward expanding the system's availability globally.
Promising Results
Results from the HYDRAFIL-D study have demonstrated more than 80% improvement in Oswestry Disability Index (ODI) scores and greater than 70% reduction in Numeric Pain Rating Scale scores after HYDRAFIL treatment. These improvements were sustained for two years in the 63 patients that have completed their two-year follow-up visit.
Dr. Olivier Clerk-Lamalice, MD, FIPP, a fellowship-trained interventional radiologist and Chief Executive Officer of Beam Radiology in Calgary, Canada, has witnessed the effectiveness of HYDRAFIL in reducing pain and disability. Bill Niland, Co-Founder and CEO of ReGelTec, expressed his anticipation about securing additional capital to support ongoing investment in the U.S. and globally, leveraging the momentum generated by the CE Mark approval and ongoing clinical trials.
The HYDRAFIL System is an outpatient procedure designed to reduce pain, improve daily function, and eliminate the need for invasive surgeries. This advancement in medical device manufacturing news holds the potential to transform the treatment landscape for chronic low back pain, offering a quicker, less invasive alternative with promising outcomes.
For more related information, readers are invited to refer to "Medical Plastics Insights" and other relevant articles in the field.
[1] ReGelTec Inc. (2021). HYDRAFIL System Receives CE Mark Approval [2] ReGelTec Inc. (2021). HYDRAFIL-D Study Commences Enrollment [3] FDA (2021). ReGelTec's HYDRAFIL System Granted IDE for U.S. Pivotal Study
- The HYDRAFIL System, a promising advancement in treatment for chronic low back pain, has received CE Mark approval under the EU MDR, demonstrating its compliance with stringent health, safety, and environmental standards in medical devices.
- As a Class III medical device, the HYDRAFIL System underwent extensive testing and evaluation, including clinical trials, to ensure its safety and effectiveness, making it akin to a significant contribution to the field of health and wellness, particularly in the management of chronic diseases like chronic low back pain.
- With ongoing clinical trials like the HYDRAFIL-D study, showing over 80% improvement in ODI scores and greater than 70% reduction in Numeric Pain Rating Scale scores, the future of medical plastics and medical devices in the treatment of medical-conditions such as degenerative disc disease could potentially witness a transformational shift, promoting fitness and exercise by reducing the need for invasive surgeries and improving health and well-being.
