The Food and Drug Administration did not approve a product by Medtronic, the medical device giant. This has given them a major setback and there are dialogues going on to try and convince the FDA for the same.

Medtronic was of the hope of bringing this product to the market, but has received a major blow after the FDA did not accept it. It is an Amplify Spinal product and FDA merely sent a letter to the company stating that it could not approve the product.

According to Medtronic, “We are in active dialogue with the FDA to address the issues in its letter, have been given the opportunity by the FDA to provide further information relevant to these issues, and are hopeful that the FDA will ultimately approve amplify”. The Company did not reveal the actual words of the letter or the other information sought by the FDA.

The product is made for the people who suffer from a degenerative disease of the disc. The amplify product is supposed to be fused in the lower spine of the patients.

The product has a genetically engineered protein that can be used for the promotion of growth in the bone. It is, according to the firm, a safe and effective alternative to a standard spinal surgery, in which there is a hip bone implantation in the spine.