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Because of the frequent interactions with the FDA over the last several weeks regarding relatively minor modifications, In Vivo chose to postpone updates on the INSPIRE study until there was clarity regarding the path forward.“We are pleased that the FDA has approved expansion of the INSPIRE study that clears the way for enrolling all 20 evaluable patients,” Perrin said.Although these two screen failure patients were not implanted with the Neuro-Spinal Scaffold, they were technically enrolled into the INSPIRE study. After reviewing the six-month safety data, the FDA requested minor modifications to the INSPIRE study protocol and informed consent documents.Therefore, the study had enrolled 12 patients by the end of May (when the 10th patient was implanted by Coric) and the enrollment of additional patients required action from the U. These modifications are being incorporated, and the FDA has approved the enrollment of additional patients to allow for 20 evaluable patients (with six months of follow up data) in the INSPIRE study.D., approximately 40 hours after the injury occurred.Each loss of an individual with a spinal cord injury strengthens our resolve to develop and bring to market new treatments that will improve the lives of patients with these devastating injuries,” said In Vivo CEO and Chairman Mark Perrin.The 10th patient, however, died from a stroke several days after surgery.In addition to the 10 implanted patients, two patients were screen failures, which means the patients consented to participate in the study but failed to meet all of the inclusion and exclusion criteria of the study.Expansion of INSPIRE Study The INSPIRE study was initially approved to enroll 12 patients pending review of six-month safety data from the first five patients implanted with the Neuro-Spinal Scaffold. has provided an update on the INSPIRE study of the Neuro-Spinal Scaffold.

Patient Enrollments Tthe ninth and 10th patients have been implanted with the Neuro-Spinal Scaffold in the company's INSPIRE study.The ninth patient received the implant at Vidant Medical Center, a Level 1 trauma center in Greenville, N. The procedure was performed by Vidant Medical Group neurosurgeons Stuart Lee, M.C.), and a member of the INSPIRE Study Steering Committee. William Bockenek, chief medical officer at Carolinas Rehabilitation, are co-principal investigators at this site.The 10th patient received the scaffold approximately 18 hours after the injury by Domagoj Coric, M.We are excited to be a part of the INSPIRE study and look forward to following the patient’s progress” Lee said.

“We express our condolences to the family of the patient who passed away.