This article is more than 5 years old. Information may no longer be current.
FDA grants IDE approval for clinical trial of LifeSeal GI surgical sealant
Click Here to Manage Email Alerts
The FDA has given Investigational Device Exemption approval to LifeBond for a clinical trial of its LifeSeal surgical sealant kit, designed to provide an elastic staple-line reinforcement to reduce leakage in GI resection procedures, according to a press release from the manufacturer.
Enrollment in the randomized, double arm, single blind safety and efficacy trial has begun at clinical centers in Europe and will be initiated in the U.S. in the coming months.
“Given the associated challenges and complications of low anterior resections (LAR), developing a sealant for preventing leakage in GI resection procedures is an extremely ambitious undertaking since leakage rates can reach more than 20%,” Sachi Norman, MD, LifeBond’s chief medical officer, said in the press release. “LifeBond’s LifeSeal is designed to address these challenges.”
A previous European clinical study of 70 patients showed a trend for reduction of leakage, with eight leaks occurring in patients with standard treatment compared with three in patients treated with LifeSeal, he added. “These results indicate that LifeSeal has great potential to improve patient outcomes following colorectal resection procedures.”
LifeSeal received CE marking for sale in Europe earlier this year and Expedited Access Pathway designation from the FDA last year. It is currently being commercialized in several European countries, but is an experimental device only approved for use in the IDE study in the U.S.
“We are delighted to have the support of the FDA to begin a larger trial to further confirm existing findings and to inch closer to bringing this important product to the market in the U.S. as well,” Gideon Sturlesi, LifeBond’s CEO, said in the press release.
Disclosures: Norman and Sturlesi are employed by LifeBond.