SECURE Post-Market Study

Inclusion criteria

• Subjects aged 18 years or older at the time of signing the informed consent form.
• Subjects undergoing surgical repair of an acute peripheral nerve injury as follows:

• Digital sensory nerve with associated tendon injury, OR
• Digital sensory nerve without tendon injury.
• Nerve must be completely transected and appropriate for primary repair.
• Nerve ends can be reapproximated without excessive tension and without the need for nerve grafting.
• Wound can be adequately cleaned and has sufficient healthy soft tissue to allow primary closure without adjunctive soft tissue procedures.
• Nerve injury is deemed by the surgeon to be suitable for repair using COAPTIUM® CONNECT.
• Subject is willing and able to provide written informed consent prior to any study specific procedures.
• Subject is willing and able to complete all required visits and procedures at baseline, 1 month, 3 months, 6 months, and 12 months.

Exclusion criteria

• Known or suspected hypersensitivity to any constituents of the product, including the polymer (Aminated polyglycerol sebacate acrylate) or the additive FD&C Blue No. 1 Dye (brilliant blue FCF);
• Known diagnosis of peripheral neuropathy;
• Any injury requiring revascularization due to critical ischemia from damage to the blood vessels;
• Subject's traumatic lesion is older than 14 days at the time of surgery;
• Use of photosensitizing medications at the time of informed consent.
• Concomitant neuromodulator medication;
• Life expectancy less than 1 year;
• History of neuropathic pain in the affected extremity;
• History of injury to the nerve being studied;
• Missing contralateral digit or history of injury to the contralateral digit (comparison/control area);
• Unwillingness/inability to follow postoperative instructions/follow-up visits;
• Concomitant intake of systemic immunosuppressive medications, steroids (>20mg of prednisone /day or equivalent) and chemotherapy;
• Prior radiation therapy to the surgical site;
• Pregnancy detected by a positive pregnancy test or planned pregnancy during the study period or breast-feeding women;
• History of chronic ischemic disease involving the affected limb;
• Diagnosis of type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (at the discretion of the investigator);
• Subject is currently participating in a study involving an investigational device/drug that has not reached its primary endpoints or would interfere with the study endpoints.

Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials;

• Previous injury, surgery, pathology involving the same nerve or extremity;
• Active infection at the surgical site;
• In the opinion of the Investigator, the subject is not a suitable candidate for the clinical investigation.