|Cohera Medical's TissuGlu technology--Courtesy of Cohera Medical|
Cohera Medical's TissuGlu surgical adhesive took another step towards securing PMA approval from the FDA, following the narrow recommendation of the agency's General and Plastic Surgery Advisory on Aug. 1. The panel voted unanimously that the device is safe, 6-5 that it is effective and 6-4 (with one abstention) that it has a favorable risk-benefit profile.
Manufactured by Cohera Medical, the TissuGlu adhesive is delivered via a handheld applicator that contains 5 milliliters of the adhesive, according to meeting literature issued by the FDA. The proposed indication facing the panel was for "the approximation of tissue layers" in large-flap surgical procedures such as abdominoplasty (tummy tuck surgery).
Cohera says the CE-marked TissuGlu encourages early healing of wounds and potentially eliminates the need for surgical drains, which the company says are associated with infections, scarring and other wound-healing complications. Surgeons typically use drains to remove pus and other bodily fluids from wounds and surgical incisions to prevent the formation of seromas, or the buildup of bodily fluids over the site of surgery.
"Today's positive Panel outcome is one of the final, and most critical, milestones towards the commercialization of TissuGlu in the U.S., and is the result of a coordinated and collaborative effort by the Cohera Medical team," CEO Patrick Daly said in a statement. "We are very pleased with the outcome of today's meeting and will continue to work with the FDA to make TissuGlu available to surgeons and patients throughout the United States."
The panel's vote is nonbinding but, based on past precedent, will likely influence the FDA's final go or no-go approval decision. And the positive recommendation, though narrow, could be especially important this time around, given the fact that the failed to meet in its first pivotal trial. The product was not effective in reducing the days to drain removal or the cumulative wound drainage output in comparison to a control group that received standard care without TissuGlu, according to an FDA executive summary of the PMA application that is issued prior to advisory panel meetings.
But the panelists were more swayed by the results of the second pivotal trial, which found that patients in the test group who used the device showed a statistically significant reduction in the number of postoperative invasive treatments compared to the control group. The device also performed well on patient-reported quality-of-life measures in the second trial. In that trial patients in the test group were more likely to take a shower after three, 6 and 9 days than those who did not receive TissuGlu, according to the executive summary.
Regarding safety, the panelists were unconcerned by data showing that almost one-third of TissuGlu patients experienced nonserious device-related adverse events and 6% experienced serious device-related adverse events, including seroma formation and surgical site infections.
Questions posed to the committee focused on the possible use of the device in cancer patients and in other large-flap surgical procedures besides abdominoplasty. Although the two pivotal trials were performed on abdominoplasty patients only, Cohera says the device has been used to treat other large-flap procedures, such as inguinal lymph node dissection for the treatment of malignant melanoma, in Europe--where the product has had CE-approval mark since 2011. So far, more than 1,500 procedures have been conducted with the device, Cohera says.
If TissuGlu is approved it will be interesting to see if the final indication specifies in which large-flap procedures besides abdominoplasty the product is intended for use, if any. The final indication may remain open-ended like the proposed indication (for use in "large-flap surgical procedures such as abdominoplasty").
Privately held, Pittsburgh, PA-based Cohera secured a $26.3 million in Series D financing in January. In May, the company filed for a CE mark for its Sylys surgical sealant for preventing leakage during gastrointestinal procedures.
- read the release from Cohera Medical
- here is the meeting literature from the FDA