In the last couple of days, i had an email correspondance with UC San Diego centre which is part of the trials : Read from bottom ups
3. Not necessarily. There is a potential that the FDA could approve the LINX device before then. We would just continue to collect long-term follow-up data on the initial patients. Unfortunately, I am unable to predict exactly when the FDA will approve the device, but we are hopeful that it would actually be sometime within the next few years.
Ok, thanks for your note. That would mean that the FDA decision is atleast 3 years away, if not more. Am I reading this correctly ?
2. The current trial is in its follow-up phase only. Patients are currently around 2 years post-op and will be followed through 5 years post-op… so there are about another 3 years of follow-up to go for patients already on this study.
1. Torax, the company who manufactures the LINX device, is hoping that the additional follow-up data will help with FDA approval. Unfortunately I am unable to predict when this device may be FDA-approved and available for use outside of a clinical trial.