Medtronic (NYSE:MDT) said today it launched a long-term clinical study of its Infuse bone graft for use during posterolateral fusion and transforaminal lumbar interbody fusion spine procedures.
The 1st patient in the study was enrolled at Indiana’s Fort Wayne Orthopedics and underwent a procedure led by Dr. Kevin Rahn and Dr. Robert Shugart, Fridley, Minn.-based Medtronic said.
“Failed back surgery is a real concern with long-term implications, and successful outcomes in PLF and TLIF procedures require solid fusion. We believe there is significant data on the safety and efficacy profile of Infuse in approved ALIF and OLIF procedures, and we are hopeful this clinical study program can generate evidence about the potential to use this important technology to help a broader group of patients,” Virginia Spine Institute prez Dr. Brian Subach said in a prepared statement.
The newly launched Bone global clinical program aims to expand clinical understanding of the Infuse bone growth protein and evaluate the efficacy, safety and health-economic outcomes when used in PLF and TLIF spine procedures, Medtronic said.
The 10-year program is looking to enroll 550-700 individuals between the pilot and pivotal studies of both procedures. A PLF pilot dosing study, slated to enroll 125 patients, will be followed by a TLIF pilot dosing study in 2018, the company said. If successful, the trials will be followed by a larger pivotal study.
“Infuse is one of the most extensively-researched biologic agents commercially available today and Medtronic continues to invest in research of Infuse to deepen the understanding of the benefits and risks of this novel treatment. We’re hopeful that if successful, the trials will generate additional data to expand indications and provide surgeons with additional options to help alleviate pain and restore health for more patients,” Medtronic spine division prez Doug King said in a press release.
Approved in 2002 for use in spinal fusion surgery, Infuse at 1 point had annual sales of nearly $1 billion. The bone-grafting product has since been linked to abnormal bone growth, certain cancers and male reproductive problems. Medtronic has been accused of not only downplaying the product’s risks but also promoting it for off-label use.
In July, Medtronic said it was closing in on a resolution to the long-running legal battles over its Infuse bone-growth protein.