Medtronic has received FDA approval to move forward with a prospective, randomized pivotal clinical trial that will examine the use of Infuse in transforaminal lumbar interbody fusions.
Medtronic has already begun recruiting patients for the trial, which could include up to 50 sites and 1,000 patients. The company is also in the process of enrolling patients in a separate clinical trial, approved in 2017, that examines Infuse for posterolateral fusions.
The FDA and Medtronic are working together to incorporate retrospective safety and efficacy data into the PLF clinical trial. Infuse originally hit the market in 2002 and has been used in 2 million patients since then.
"Medtronic continues to invest in scientific evidence on Infuse to continue adding to the growing body of clinical data, and we believe these trials will generate additional data to expand indications, increase access to surgeons and alleviate pain and restore health for patients around the world," said Jacob Paul, senior vice president and president of Medtronic's spine division in the Restorative Therapies Group.
Both clinical trials are investigational only.
Infuse is a bone morphogenetic protein product, rhBMP-2. According to Grand View Research, the BMP market was valued at $504.2 million in 2015, but expected to grow through 2024.
For the first quarter of the 2020 fiscal year, Infuse sales grew in the low-double digits.