Medtronic TLIF Infuse Spine Trial FDA Cleared

Medtronic Logo, Courtesy of Medtronic

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Transforaminal lumbar interbody fusion (TLIF) is a spinal procedure where devices are implanted posterolaterally, or from the side. This approach avoids the exposure of nerve roots and posterior ligaments and is used to treat the lower back region of the spine. In a recent victory, Medtronic will begin clinical trials for its own TLIF Infuse Bone Graft after winning approval from the FDA.

Indiana Spine Group orthopedic spine surgeon Dr. Joseph Smucker believes that “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,” and that “when considering the patient, site and procedure, Infuse can be a powerful option in a spine surgeon’s armamentarium. This study has the potential to add to the broader clinical and scientific evidence regarding use of Infuse, and may allow surgeons to better understand its safe and effective use in TLIF procedures.”

According to iData Research’s analysis, TLIF is the largest segment in the interbody device market and is gaining popularity because it is less invasive, with fewer complications than PLIF procedures. TLIF was the only lumbar approach segment that increased, while both ALIF and PLIF are experiencing decreases in market size. The TLIF segment of the interbody device market can expect a positive contribution with Medtronics’ Infuse Bone Graft clinical trials, but the overall market may slowdown in growth as ALIF and PLIF are slowing down in growth.

Medtronics’ Infuse Bone Graft has been on the market since 2002. In a prepared statement, spine SVP Jacob Paul said that “with 17 years of clinical use, Infuse bone graft has become one of the most extensively-researched biologic technologies commercially available today.” He states that “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.”


For Further Information

To get in an in-depth market overview and to see an extensive portfolio of innovations in technology, please read iData Research’s’ 6976 page Global Spinal Implants Market Analysis, Size and Trends Report.

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