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The long road to FDA approval for spinal biologics

The long road to FDA approval for spinal biologics

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By Newzino Staff |

INFUSE Bone Graft Expands to New Procedures After Two Decades of Controversy and Redemption

4 days ago: FDA Approves INFUSE for TLIF

Overview

For 24 years, Medtronic's INFUSE bone graft has followed a winding path through FDA approval, off-label controversy, lawsuits, and now expansion. The Food and Drug Administration (FDA) just granted INFUSE approval for transforaminal lumbar interbody fusion (TLIF) procedures—making it the only growth factor bone graft approved for two-level spinal constructs and the only one cleared for anterior, oblique, and transforaminal approaches.

This matters because over 450,000 spinal fusion procedures are performed annually in the United States, and surgeons have long faced a choice: harvest bone from a patient's hip (causing pain and complications in one-third of cases) or use synthetic alternatives with limited FDA backing. INFUSE now offers an approved option for the most common lumbar fusion technique, potentially eliminating a second surgical site for thousands of patients each year.

Key Indicators

90%+
Fusion Rate
Clinical trial success rate for INFUSE in TLIF procedures across 493 patients
450,000
Annual Fusions
Approximate number of spinal fusion procedures performed yearly in the United States
$5.2B
Market Size
Projected global spine biologics market by 2031, growing at 5% annually
6,000+
Lawsuits Settled
Number of INFUSE product liability cases Medtronic resolved through 2017

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People Involved

Jacob Rosenstein, MD
Jacob Rosenstein, MD
Neurosurgeon, North Texas Neurosurgery (Active spine surgeon with 46 years of experience)

Organizations Involved

Medtronic plc
Medtronic plc
Medical Device Company
Status: Developer and manufacturer of INFUSE bone graft

Global medical technology company and the largest pure-play medical device maker in the world.

U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal Regulatory Agency
Status: Regulator of medical devices including bone grafts

Federal agency responsible for protecting public health through regulation of medical devices, drugs, and biologics.

Cerapedics Inc.
Cerapedics Inc.
Medical Device Company
Status: Competitor with FDA-approved PearlMatrix P-15 bone graft

Westminster, Colorado-based company developing peptide-enhanced bone graft products for spinal fusion.

Timeline

  1. FDA Approves INFUSE for TLIF

    Regulatory

    FDA grants premarket approval for INFUSE bone graft in transforaminal lumbar interbody fusion at one and two levels from L2-S1. This makes INFUSE the first growth factor approved for two-level spinal fusion constructs.

  2. Medtronic Submits TLIF Application

    Regulatory

    Medtronic submits panel-track premarket approval application to FDA for INFUSE in TLIF procedures.

  3. Competitor PearlMatrix Wins FDA Approval

    Regulatory

    Cerapedics receives FDA premarket approval for PearlMatrix P-15 peptide enhanced bone graft for single-level TLIF, creating first direct competitor to INFUSE.

  4. FDA Grants Breakthrough Device Designation

    Regulatory

    FDA grants Breakthrough Device designation for proposed INFUSE TLIF indication, expediting the review process.

  5. FDA Approves INFUSE for ALIF and OLIF

    Regulatory

    FDA approves INFUSE for use with PEEK interbody implants in oblique lateral interbody fusion (OLIF) and anterior lumbar interbody fusion (ALIF) at a single level.

  6. Final Batch of Lawsuits Settled

    Legal

    Medtronic resolves remaining INFUSE lawsuits, having settled approximately 6,000 cases total. Company set aside $300 million for litigation charges.

  7. Medtronic Settles 950 Product Liability Cases

    Legal

    Medtronic agrees to settle approximately 950 INFUSE product liability lawsuits for around $22 million.

  8. Senate Report Finds Research Manipulation

    Investigation

    Senate Finance Committee report determines Medtronic employees collaborated with physician authors to edit and write segments of published INFUSE studies without disclosure. Company paid $210 million to 13 doctors who co-authored the research.

  9. Medtronic Settles Shareholder Lawsuit

    Legal

    Medtronic pays $85 million to settle shareholder lawsuit accusing the company of making misleading statements about INFUSE.

  10. Senate Launches Investigation

    Investigation

    U.S. Senate Finance Committee opens 16-month investigation into Medtronic's relationships with physician consultants who tested and reviewed INFUSE products.

  11. INFUSE Approved for Posterolateral Fusion

    Regulatory

    FDA approves INFUSE for use in posterolateral spine fusion surgery to repair pseudarthrosis (failed fusion).

  12. FDA Issues Safety Warning on Cervical Use

    Safety

    FDA issues public health notification warning about life-threatening complications—including throat swelling, breathing difficulties, and death—when INFUSE was used off-label in cervical spine fusions.

  13. INFUSE Approved for Oral Surgery

    Regulatory

    FDA approves INFUSE as an alternative to autogenous bone grafts for sinus augmentations and localized alveolar ridge augmentations.

  14. DOJ Settles Kickback Allegations

    Legal

    Department of Justice investigation ends with Medtronic paying $40 million to settle allegations of illegal kickbacks to doctors as incentives to use INFUSE.

  15. FDA Expands INFUSE to Trauma Indication

    Regulatory

    INFUSE receives approval for open tibial fractures with intramedullary nail fixation, expanding beyond spinal applications.

  16. FDA Approves INFUSE for Spinal Fusion

    Regulatory

    The FDA grants initial approval for INFUSE bone graft containing recombinant human bone morphogenetic protein-2 (rhBMP-2) for single-level anterior lumbar interbody fusion from L4-S1.

Scenarios

1

INFUSE Becomes Standard of Care for Lumbar Fusion

Discussed by: Orthopedic trade publications and spine surgery professional organizations

With FDA approval now covering the three most common lumbar fusion approaches (ALIF, OLIF, TLIF) and two-level procedures, INFUSE adoption accelerates significantly. Insurance coverage expands as payers recognize the cost savings from eliminating hip bone harvest complications. Within 3-5 years, growth factor biologics replace autograft as the default option for most lumbar fusions.

2

Competition Fragments the Biologics Market

Discussed by: Industry analysts at iData Research and market research firms

Cerapedics' PearlMatrix and other emerging peptide-enhanced products capture significant market share by demonstrating superiority in specific patient populations or procedure types. Medtronic's first-mover advantage erodes as surgeons experiment with alternatives. The market becomes commoditized, driving down prices but increasing overall adoption of biological bone grafts.

3

Safety Concerns Resurface, Limiting Expansion

Discussed by: Medical device watchdog organizations and academic researchers

Post-market surveillance reveals unexpected complications in the expanded patient population, particularly in two-level fusions. The FDA issues updated safety communications, and surgeons become more conservative in patient selection. Growth plateaus as the medical community awaits longer-term outcome data.

4

Reimbursement Battles Slow Adoption

Discussed by: Spine surgery practice administrators and healthcare policy analysts

Despite FDA approval, insurance companies and Medicare maintain restrictive coverage policies for biological bone grafts, citing cost concerns and questioning whether outcomes justify the premium over traditional autograft. Adoption remains limited to specific patient populations where payers acknowledge the clinical benefit.

Historical Context

Vioxx Withdrawal and Medical Device Scrutiny (2004)

September 2004

What Happened

Merck withdrew its blockbuster painkiller Vioxx after clinical trials revealed it doubled the risk of heart attack and stroke. The drug had been marketed aggressively to physicians and patients, with safety signals allegedly downplayed in company-sponsored research. An estimated 88,000 Americans experienced heart attacks from the drug, with 38,000 deaths.

Outcome

Short Term

Merck faced $4.85 billion in settlements and congressional hearings examined FDA oversight failures.

Long Term

Congress passed the FDA Amendments Act of 2007, requiring more post-market safety studies and establishing the Sentinel System for ongoing surveillance. The scandal heightened scrutiny of industry-funded research across all medical products.

Why It's Relevant Today

INFUSE faced similar accusations of industry influence over research publications, with the Senate investigation finding Medtronic employees helped write studies without disclosure. The parallels intensified regulatory and public skepticism that the company had to overcome through subsequent rigorous clinical trials.

Metal-on-Metal Hip Implant Crisis (2010-2013)

2010-2013

What Happened

DePuy Orthopaedics (Johnson & Johnson) recalled its ASR hip replacement system after data showed nearly 40% of patients required revision surgery within five years. Metal debris from the implants caused tissue damage and metallosis, affecting over 93,000 patients worldwide who had received the devices.

Outcome

Short Term

Johnson & Johnson paid $2.5 billion to settle approximately 8,000 lawsuits. The FDA tightened requirements for 510(k) clearance of orthopedic implants.

Long Term

The medical device industry shifted toward requiring more clinical evidence before market approval, and surgeons became more cautious about adopting new implant technologies without long-term outcome data.

Why It's Relevant Today

Both INFUSE and metal-on-metal hips illustrate the tension between innovation and safety in orthopedic surgery. The hip implant crisis reinforced that FDA clearance does not guarantee long-term safety, a lesson that influenced how the agency evaluated INFUSE's expanded indications and why Medtronic invested in the 493-patient clinical trial supporting the TLIF approval.

Autologous Blood Products in Sports Medicine (2010s)

2010-2020

What Happened

Platelet-rich plasma (PRP) injections gained widespread adoption in orthopedic and sports medicine practices despite limited FDA regulation and inconsistent clinical evidence. Professional athletes publicized their use of these biological treatments, driving patient demand. The treatments proliferated largely outside the traditional FDA approval pathway.

Outcome

Short Term

The PRP market grew to over $400 million annually, with minimal regulatory oversight and highly variable preparation methods across clinics.

Long Term

The FDA began issuing warning letters to clinics making unsubstantiated claims, and medical societies developed guidelines emphasizing the need for better clinical evidence. The experience highlighted gaps in regulating biological products.

Why It's Relevant Today

The contrast between PRP's regulatory-light path and INFUSE's rigorous premarket approval process illustrates two models for bringing biological treatments to market. INFUSE's troubled history with off-label use mirrors concerns about PRP, but Medtronic's commitment to formal FDA approval for each indication represents a different approach—one that provides clearer evidence but delays access to potentially beneficial treatments.

13 Sources:
+7
Ortho Spine News MassDevice Becker's Spine Review Medtronic Newsroom International Orthopaedics Drugwatch ABC News Medscape PR Newswire Drugwatch Medtronic Newsroom Becker's Spine Review Journal of Clinical Medicine