Regulatory Decision Summary for VistaSeal

This Supplement was filed for VistaSeal (fibrin sealant [human]) to extend the approved indication to pediatric patients. After evaluation of the submitted data package, Health Canada authorized VistaSeal for the following indication:

VistaSeal (Fibrin Sealant [Human]) is indicated in adult and pediatric patients (< 18 years) for supportive treatment in surgery for improvement of hemostasis, and for suture support in vascular surgery, where standard techniques are insufficient.

Authorization of VistaSeal in the pediatric setting was based on a phase III, randomized, active-controlled, parallel group clinical trial comparing the efficacy and safety of VistaSeal versus Evicel as an adjunct to hemostasis during elective, open (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedures in pediatric subjects (IG1405 trial). A total of 178 pediatric subjects (< 18 years of age) received the treatment, 91 subjects and 87 subjects received VistaSeal and Evicel, respectively. A total of 96.7% subjects from the VistaSeal group and 95.4% subjects from the Evicel group met the primary efficacy endpoint (proportion of subjects achieving hemostasis), and showed that VistaSeal was not inferior to Evicel.

There was no apparent difference in the safety profile between VistaSeal and Evicel in pediatric patients. The most frequently reported treatment-emergent adverse events were vomiting, nausea, abdominal distension, wound infection, wound dehiscence, pyrexia and anemia. No treatment-related deaths and serious adverse reactions were reported. Only 1 subject (1.1%) reported 1 treatment-emergent adverse event (moderate procedural pain) that was considered possibly related to VistaSeal.

The results of an ad hoc analysis in pediatric patients (n = 22) enrolled in the IG1102 and IG1103 trials further support the efficacy and safety of VistaSeal in pediatric patients.

The recommended dose must be individualized based on the anatomic site of surgery and size of targeted surface area in pediatric patients. The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area with a thin (1 mm thick) layer. The application can be repeated, if necessary. The maximum doses used in clinical trials in adult and pediatric patients are included in the Product Monograph for VistaSeal.

An updated Risk Management Plan (RMP) for VistaSeal was reviewed by Health Canada and considered acceptable.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

Based on the evidence provided, the overall benefit and risk profile of VistaSeal in pediatric patients for supportive treatment in surgery for improvement of hemostasis, and for suture support in vascular surgery, where standard techniques are insufficient, is considered favourable. Therefore, a Notice of Compliance was recommended.

For more information on the benefits and risks of VistaSeal, refer to the product monograph approved by Health Canada and available through the Drug Product Database.