LifeBond received FDA Investigational Device Exemption approval to begin a clinical study of the LifeSeal Surgical Sealant Kit, which includes a gastrointestinal sealant.
Here are four things to know:
1. The GI sealant is designed to minimize staple-line leakage in gastrointestinal resection procedures.
2. The FDA trial will be a multi-center, multinational, randomized, double-arm, single-blind study.
3. There will be study sites in both the Unites States and Europe.
4. The LifeSeal Surgical Sealant Kit has received the CE Mark.