Simplify Medical, maker of the Simplify cervical artificial disc, has announced that it has completed the enrolment and treatment of all patients in its US Investigational Device Exemption (IDE) pivotal trial evaluating the Simplify Disc for two-level cervical disc replacement. The Simplify Disc is designed for biomechanical motion, anatomical height-matching, and MRI compatibility with a goal of simplifying the treatment of degenerative disc disease.
The prospective, multi-centre clinical trial enrolled a total of 200 patients at 18 clinical sites across the USA. The primary endpoint of the study is the clinical success rate of Simplify Disc in two contiguous levels from C3 to C7 compared with two-level anterior cervical discectomy and fusion (ACDF). The company announced the completion of enrolment for its one-level IDE trial in February 2018.
David Hovda, CEO of Simplify Medical, said, “Our two-level trial has generated an exceptional level of interest, which has allowed us to complete study enrolment more quickly than anticipated. We thank all of our dedicated surgeon investigators who have participated in the trial and look forward to working with them to complete the study.”
Domagoj Coric, chief of Neurosurgery at Carolinas Medical Centre and national co-primary investigator for the study as well as co-primary investigator of the one-level study, stated, “Given its compelling feature set and the early positive feedback, I believe the Simplify Disc represents the future of cervical disc arthroplasty. I look forward to providing my patients with this technology as it becomes commercially available and am eager to share clinical data when available.”
Richard Guyer, chairman of the Texas Back Research Institute Foundation and national co-primary investigator for the study as well as co-primary investigator of the one-level study, commented, “The Simplify Disc has the potential to offer an attractive alternative for two-level disease by simplifying procedure complexity compared to other marketed devices, providing motion, and better matching patient anatomy with lower disc heights that avoid excessive wear. We look forward to sharing outcomes at upcoming spine meetings.”
The Simplify Disc is being evaluated in separate IDE trials in the USA for one- and two-levels. The Simplify Disc is CE Marked in Europe and commercially available in select European markets. Internationally, early market feedback has shown substantial improvement in patient pain scores and functional improvement after treatment.