A study published in Spine analyzed the safety and efficacy of performing total disc replacement procedures in ambulatory surgery centers.
The study verified the safe completion of TDR in ASCs with good clinical and patient-reported outcomes, when compared to anterior cervical discectomy and fusion procedures and previous two-year TDR studies.
Here are five observations:
1. Malden, Mass.-based AxioMed's President Jake Lubinski reacted to the study by observing that cervical TDR is "becoming a standard outpatient procedure, and AxioMed is leading the way with the most advanced disc replacement on the market."
2. Mr. Lubinski's believes many surgeons will use the AxioMed viscoelastic disc for outpatient surgeries, including multilevel surgeries. Kingsley Chin, MD, performed the first viscoelastic four-level cervical procedure at Andrews Memorial Hospital in Kingston, Jamaica, on Jan. 30, 2017.
3. The company has already conducted a preclinical European study, and Mr. Lubinski said they are now shifting focus to beginning a U.S. Investigational Device Exemption study for the multilevel cervical application.
4. The AxioMed viscoelastic disc is designed to restore natural disc alignment and motion.
5. Malden, Mass.-based KICVentures acquired AxioMed in 2014, but AxioMed still owns an exclusive viscoelastic material license on the disc's technology.