There are no direct alternatives to DuraStat. The product has unique capabilities which help to create reproducible primary closures of the dura when it would otherwise not be possible. The only alternative for primary Incidental Durotomy (ID) repairs are conventional instruments such as needle holders/drivers, however these instruments do not meet the unique needs of durotomy repair.
DuraStat is applicable when access to repair a dural tear is limited and hand suturing is difficult. DuraStat closures are also higher quality due to precisely aligned edges and minimized suture hole leakage; because of this, DuraStat is applicable for all tears.
DuraStat is applicable in any situation where access to repair a dural tear is limited and hand-suturing is difficult, or not possible. While these situations are rare, they can happen regardless of the exposure size.
Since DuraStat automates the process of suture passage with a novel deployment mechanism, the suture and needle combination was selected to optimize the reproducibility of the device’s functionality and ease of use for the surgeon. The suture is easy to handle and has low-memory so that it can be loaded into the instrument’s tip. The needle creates a round puncture that is the same size as the following suture to minimize the possibility of leaks associated with the needle hole; a common challenge associated with conventional methods.
DuraStat, LLC is not aware of any reimbursement codes available specific to incidental durotomy.
DuraStat cannot be reloaded after the needle has been deployed because it would require the device to be larger and more complex, negatively impacting visualization, reproducibility and adding significant time for reloading. Ultimately, this would compromise the satisfaction of the unmet clinical need, which is to provide a tool for easy, fast and reproducible use, with increased closure quality.
For large tears, DuraStat may be used to gain control of the center of the tear, using the ability to select a precise location on either side of the tear, while avoiding nerve tissue damage. After the tear is closed in the center, the suture may be used to tent the dura up and away from the underlying nerve roots while additional sutures are placed, either with DuraStat, or conventional methods.