I emailed the Company re-the linx and this was there response...
I asked them when was going to be approved in the States.. and the FDA
Thank you for your inquiry.
Torax has submitted a pre-market approval application to the FDA for the LINX System. Torax cannot predict if the FDA will or will not approve the LINX System. Please watch our website for updates, www.toraxmedical.com.
The LINX System has received CE mark approval and is currently being implanted in Italy, Germany, and the United Kingdom.