FDA Approval of DIAM Spinal Stabilization System: A New Pathway in Spine Care

The DIAM Spinal Stabilization System received FDA premarket approval (PMA), authorizing a motion-preserving implant option for single-level lumbar degenerative disc disease (DDD) and expanding non‑fusion choices for spine clinicians. The device offers a less invasive, posterior, motion-preserving approach that may allow selected patients to avoid fusion after failed conservative care.

The manufacturer's press release and regulatory notice summarize a prospective, randomized, multicenter Investigational Device Exemption (IDE) trial that supported the FDA decision; the trial used Composite Clinical Success (CCS) as the primary endpoint.

The trial reported a 67.4% CCS rate for DIAM versus 11.9% for non‑operative care — a large absolute difference that will influence treatment discussions. The perioperative and safety profile was described as favorable, with low device‑related serious adverse events and low reintervention and removal rates. These outcomes suggest DIAM is best considered for patients with preserved segmental motion who prioritize symptom relief without immediate fusion.

Durability signals were notable: average follow‑up was approximately 11.5 years, and 87% of participants reported they would choose the same treatment again. Functional and quality‑of‑life measures, including ODI and back‑pain responder rates, remained improved through long‑term follow‑up, making durability and patient satisfaction key counseling points.

Appropriate candidates are patients with single‑level DDD (L2–L5) and preserved motion who remain symptomatic after at least six months of conservative care. Implantation uses a minimally invasive posterior approach; sites should anticipate a device‑specific learning curve and plan perioperative workflow adjustments. As DIAM enters broader practice, clinicians should monitor real‑world registry data, payer coverage decisions, and evolving postmarket safety surveillance.

Key Takeaways:

• DIAM received FDA PMA based on a prospective, randomized, multicenter IDE trial with a CCS primary endpoint, offering a motion‑preserving alternative to fusion.
• The trial reported 67.4% CCS with DIAM versus 11.9% with non‑operative care, with low device‑related serious adverse events and durable outcomes at ~11.5 years.
• Appropriate candidates are single‑level, motion‑preserved DDD patients after failed conservative care; monitor adoption, reimbursement, and registry evidence as use expands.