Shots:
- ReGelTec has received European MDR CE Mark approval for its Class III HYDRAFIL System, a disc augmentation therapy designed to reduce pain, improve daily function & eliminate the need for invasive surgeries
- Approval was based on a study of 75 pts showing over 80% improvement in Oswestry Disability Index (ODI) scores & >70% pain reduction in Numeric Pain Rating Scale scores, with sustained benefits at 2yrs. in 63 pts who completed follow-up visit
- Following the US FDA’s IDE approval backed by CE Mark data, the HYDRAFIL System is being studied in HYDRAFIL-D trial enrolling 225 pts across 8 US sites, with interim safety analysis planned after the first 60 pts complete 6mos. follow-up; enrollment is ongoing
Ref: Businesswire| Image: ReGelTec| Press Release
Related News:- The US FDA Grants 510(k) clearance to Stryker’s OptaBlate BVN System for Vertebrogenic Pain
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