New Haven, Conn.-based Soft Tissue Regeneration, developer of resorbable polymer scaffolds for repairing soft tissue injuries, initiated a randomized and controlled clinic study for its L-C-ligament device in Europe.
Here are five takeaways:
1. The device is used for the reconstruction of a ruptured anterior cruciate ligament.
2. The study's results will be submitted to regulatory authorities to get approval for Soft Tissue Regeneration to market the device in most European markets.
3. The first three patients of the study were enrolled and treated on Sept. 24, 2015. All three of the patients were successfully treated. Two patients received the L-C Ligament device and the other patient was treated using tendon harvested from the patient's own hamstring.
4. The clinical trial will compare the L-C Ligament to the hamstring autograft of 60 patients who need surgical reconstruction for an acute ACL injury.
5. A global trial in the United States and Europe is expected to begin in late 2016.
More articles on devices:
InVivo's pilot study expands to 10 spinal cord injury patients — 5 key notes
Stryker, Ziehm Imaging enter into co-marketing agreement: 4 key notes
Promimic enter into strategic venture: 4 things to know