Surgical adhesive manufacturer Cohera Medical, Inc.® tells us it has submitted its fourth and final FDA PMA module that would ultimately see TissuGlu® indicated for reducing drainage following abdominoplasty procedures in the US.
Cohera’s TissuGlu urethane-based adhesive was CE marked over two years ago for use in large flap surgeries. Now the company is seeking US approval for effectively the same indication, that of closing voids between tissue layers, left behind after procedures such as abdominoplasty and mastectomy. Currently both procedures commonly employ drains, inserted to remove accumulations of fluid at the surgical site. Avoidance of the need for drains would be highly desirable, given their unpopularity with patients, inconvenience and potential to introduce complications. TissuGlu effectively sticks tissue layers together, theoretically removing the potential for fluid-filled voids to appear.
The company recently announced clinical study findings that suggest a no-drain approach using TissuGlu resulted in abdominoplasty patients provided clinically superior results, fewer post-operative treatments and earlier resumption of normal activities, as compared with closed-suction drainage.
The FDA’s new modular approach to PMA submission is seen as being a more efficient way of passing through the process, modules being submitted separately over time which may allow for a more efficient review when the last components are submitted because much of the review work will have already been completed.
Cohera Medical has already successfully submitted the first three modules of the PMA application: biocompatibility, design control and manufacturing.
The fourth and final module submitted is comprised of data from Cohera Medical’s ‘No Drain’ study, confirming that TissuGlu is a clinically superior alternative to closed-suction drains for fluid management in large flap procedures such as abdominoplasty. In the pivotal clinical trial, when TissuGlu was used, patients required fewer post-operative treatments and resumed normal activities, such as going to work, showering and using the stairs, more quickly.
“We are pleased to have submitted the final module of the PMA application for TissuGlu,” said Chad Coberly, JD Vice President of Clinical, Regulatory and Legal affairs of Cohera Medical. “This module culminates substantial work by the Cohera team and our investigational partners.”
“Submitting the final module to FDA is a critical milestone in making TissuGlu Surgical Adhesive available to surgeons and patients in the U.S.,” said Patrick Daly, President and Chief Executive Officer of Cohera Medical. “The successful completion of this module represents a huge effort on the part of the entire company and we look forward to continuing our work with FDA.”
Source: Cohera Medical, Inc., PR Newswire