Medtronic has secured approval from the US Food and Drug Administration (FDA) to begin a new clinical trial to evaluate the use of Infuse bone graft in transforaminal lumbar interbody fusion (TLIF) spine procedures.
A TLIF is a type of surgery, which fuses or joins bones of the spine through a posterior approach. It will help treat certain painful conditions of the lumbar or low back region of the spine.
Indiana Spine Group orthopaedic spine surgeon and the trial principal investigator Dr Joseph Smucker said: “The potential to expand the indications for use of Infuse in posterior spine procedures may give a broader group of patients access to this novel biologic technology.”
Medtronic begins site enrollment for TLIF clinical trial
The company has started site enrollment for the TLIF clinical trial. It is planning to recruit up to 1,000 patients at 50 sites.
In 2017, the firm received FDA approval for a separate clinical trial to evaluate Infuse bone graft in posterolateral fusion (PLF) procedures.
At present, the firm is also recruiting patients in its prospective pilot PLF clinical trial, as well as working with the FDA to integrate retrospective safety and effectiveness data sufficient for indication expansion in PLF.
The application of Infuse bone graft in TLIF and PLF procedures is limited to investigational only.
Since 2002, the Infuse bone graft has been commercially available in the market and used in more than two million patients across the world to date, said the company.
The Infuse bone graft is FDA-approved for certain spine, oral-maxillofacial and orthopedic trauma surgeries.
In spine surgery, the bone graft is used with certain Medtronic interbody fusion devices at a single level for patients with degenerative disc disease (DDD).
Medtronic’s Spine division president and senior vice president Jacob Paul said: “With 17 years of clinical use, Infuse Bone Graft has become one of the most extensively-researched biologic technologies commercially available today.”
Recently, Medtronic has secured FDA approval for its next-generation Evolut PRO+ TAVR system to treat symptomatic severe aortic stenosis patients.
