GAITHERSBURG, Maryland — A US Food and Drug Administration (FDA) advisory panel voted narrowly in favor of the benefits outweighing the risks for the novel investigational product TissuGlu Surgical Adhesive (Cohera Medical, Inc).
Delivered by a handheld device, TissuGlu is a polyurethane adhesive applied as droplets onto planar tissue surfaces after large-flap surgery. It is designed to reduce the “dead space” in the wound by adhering soft tissue flaps together, thereby eliminating the need for postsurgical drains for fluid management.
The proposed indication is “for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.” It has been marketed in the European Union with that indication since 2011.
The FDA’s 11-member General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted 11 to 0 in favor of the product’s safety. But panel members were divided about its efficacy, voting 6 to 5 that there is “reasonable assurance that the TissuGlu Surgical Adhesive device is effective for use in patients who meet the criteria specified in the proposed indication.”
On the question of the product’s benefits outweighing risks, the vote was 6 yes, 4 no, and 1 abstention.
“Weird” Trial Design
The first of 2 pivotal trials, a prospective, controlled, single-blind, multicenter study of 150 abdominoplasty patients randomly assigned to either drains alone or drains plus TissuGlu, did not meet its primary endpoint of reducing the time to drain removal (6.6 vs 6.7 days, respectively). Post–weight loss patients in both groups had greater cumulative wound drainage, FDA reviewer Janette Alexander, MD, reported in her summary of Cohera’s data.
However, most of the panel’s difficulty with the efficacy data had to do with the design of the second pivotal trial, which, similar to the first, had been established in collaboration with the FDA. In that study, 130 abdominoplasty patients were randomly assigned to standard wound closure technique either with drains (control) or with TissuGlu and no drains.
The primary endpoint was the number of postoperative “invasive treatments,” defined as:
removal of an in-dwelling drain,
needle aspiration to remove fluid from a clinically diagnosed palpable seroma (all palpable fluid waves were called “seroma”),
invasive action to the drain or drain wound such as repositioning or reattaching the drain retention sutures, or
reinsertion of the drain.
In the per protocol population analysis (with 27 patients excluded, mostly for protocol violations), the total number of postoperative invasive treatments was 114 for the 52 controls vs 9 for 51 patients with TissuGlu, demonstrating both noninferiority and superiority at P < .0001, study investigator Joseph P. Hunstad, MD, associate consulting professor in the Division of Plastic Surgery at the University of North Carolina, Chapel Hill, reported.
The difference remained significant in an intent-to-treat analysis including all 130 patients. A total of 73% of the patient in the TissuGlu group required no invasive treatments. Of the 27% with invasive treatments, 21% had aspirations alone and 6% required both aspirations and drains for persistent seroma.
《FDA Advisory Panel Narrowly Endorses Surgical Adhesive》：
GAITHERSBURG, Maryland — A US Food and Drug Administration (FDA) advisory panel voted narrowly in favor of the benefits outweighing the risks for the novel investigational product TissuGlu Surgical Adhesive (Cohera Medical, Inc).
Delivered by a handheld device, TissuGlu is a polyurethane adhesive applied as droplets onto planar tissue surfaces after large-flap surgery. It is designed to reduce the “dead space” in the wound by adhering soft tissue flaps together, thereby eliminating the need for postsurgical drains for fluid management.
The proposed indication is “for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.” It has been marketed in the European Union with that indication since 2011.
The FDA’s 11-member General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted 11 to 0 in favor of the product’s safety. But panel members were divided about its efficacy, voting 6 to 5 that there is “reasonable assurance that the TissuGlu Surgical Adhesive device is effective for use in patients who meet the criteria specified in the proposed indication.”
On the question of the product’s benefits outweighing risks, the vote was 6 yes, 4 no, and 1 abstention.
“Weird” Trial Design
The first of 2 pivotal trials, a prospective, controlled, single-blind, multicenter study of 150 abdominoplasty patients randomly assigned to either drains alone or drains plus TissuGlu, did not meet its primary endpoint of reducing the time to drain removal (6.6 vs 6.7 days, respectively). Post–weight loss patients in both groups had greater cumulative wound drainage, FDA reviewer Janette Alexander, MD, reported in her summary of Cohera’s data.
However, most of the panel’s difficulty with the efficacy data had to do with the design of the second pivotal trial, which, similar to the first, had been established in collaboration with the FDA. In that study, 130 abdominoplasty patients were randomly assigned to standard wound closure technique either with drains (control) or with TissuGlu and no drains.
The primary endpoint was the number of postoperative “invasive treatments,” defined as:
In the per protocol population analysis (with 27 patients excluded, mostly for protocol violations), the total number of postoperative invasive treatments was 114 for the 52 controls vs 9 for 51 patients with TissuGlu, demonstrating both noninferiority and superiority at P < .0001, study investigator Joseph P. Hunstad, MD, associate consulting professor in the Division of Plastic Surgery at the University of North Carolina, Chapel Hill, reported.
The difference remained significant in an intent-to-treat analysis including all 130 patients. A total of 73% of the patient in the TissuGlu group required no invasive treatments. Of the 27% with invasive treatments, 21% had aspirations alone and 6% required both aspirations and drains for persistent seroma.