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XL TDR, Lumbar fusion surgery · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| XL TDR | EXPERIMENTAL | The XL TDR is indicated for reconstruction of the disc following discectomy in skeletally mature subjects with symptomatic degenerative disc disease (DDD) of the lumbar spine at one level from L1-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history radiographic studies. |
| Outcomes from lumbar fusion study | OTHER | - |
| Name | Type | Description |
|---|---|---|
| XL TDR | DEVICE | This will be a lateral approach discectomy and reconstruction with the insertion of the XL TDR device. |
| Lumbar fusion surgery | OTHER | Lumbar fusion surgery |
Inclusion Criteria: * 18-70 years of age (inclusive and skeletally mature) at the time of surgery * Diagnosis of image-confirmed symptomatic DDD at one of the following levels: L1/L2, L2/L3, L3/L4, or L4/L5 * DDD diagnosed using patient history and image-confirmation such as (but not limited to), M...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Mesoblast Limited Sponsored ADR | MESO | 1 | PHASE3 | Rexlemestrocel-L, HA mixture, Saline |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | PHASE1 | CELZ-201-DDT |
| Stryker Corporation | SYK | 2 | N/A | Undisclosed |
| Globus Medical Inc Class A | GMED | 6 | - | Undisclosed |
| Orthofix Medical, Inc. | OFIX | 1 | - | Undisclosed |
XL TDR is a lumbar total disc replacement device used for the treatment of lumbar Degenerative Disc Disease (DDD). It is designed to replace a degenerated disc in the lumbar spine to relieve pain and maintain motion. The device is currently in clinical development and is not yet approved by the FDA.
XL TDR is developed by Globus Medical, Inc., a medical device company traded on the New York Stock Exchange under the ticker symbol GMED. The company is conducting clinical trials to evaluate the safety and effectiveness of the device for treating lumbar Degenerative Disc Disease.
XL TDR is in Phase 3 clinical development. A Phase 3 clinical trial has been completed to evaluate the device for the treatment of lumbar Degenerative Disc Disease. The device is investigational and has not yet received FDA approval.
XL TDR has one completed Phase 3 clinical trial with the identifier NCT00927238. The trial, titled 'XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)', enrolled 246 participants in the United States and was completed.
XL TDR is not FDA approved. It is an investigational device currently in Phase 3 clinical development. A Phase 3 trial has been completed, but the device has not yet received marketing authorization from the FDA.