In early August, Cohera Medical, a leading innovator and developer of absorbable surgical adhesives and sealants, announced that the US Food and Drug Administration (FDA) voted favorably on the safety, efficacy, and risk/benefit of TissuGlu Surgical Adhesive as presented to the FDA panel on Plastic Surgery Devices and Medical Devices Advisory Committee.
TissuGlu is designed to meet surgeons’ need for a strong, biocompatible, and easy-to-use surgical adhesive. Clinic data supports the safety and effectiveness of TissuGlu as an alternative to using closed suction drains in large flap surgeries, decreasing the amount of post-operative invasive treatments and improving the patient recovery process.
Why is there a need for this product on the surgical market? According to Cohera Medical, there are approximately 1 million US-based large flap procedures every year and they’re increasing at a rate of 4.8 percent per year. In 2010, abdominoplasty surgeries were the fourth most common plastic surgery performed in the US. If approved by the FDA, TissuGlu would become the first internal surgical adhesive of its kind approved for large flap surgeries in the US.
In a recent interview with Surgical Products, Cohera Medical President and CEO Patrick Daly and Peter Rubin, MD, Chair of Plastic Surgery at the University of Pittsburgh, gave their thoughts on why TissuGlu could be an exciting breakthrough for patients recovering from large-flag procedures.
Surgical Products: Why was the Aug. 1 FDA vote so important to the future of TissuGlu?
Daly: It was crucial and a significant milestone for us; most companies don’t even get that far.
SP: Going forward, what is the next step for TissuGlu?
Daly: The next step is approval from the FDA. We have submitted a letter for approval and they’re working toward making a final decision. We’re hoping to get an approval letter from the FDA in early-to-mid fall.
SP: Why could TissuGlu make a positive impact on large flap procedures?
Rubin: Postoperative fluid collections are a vexing problem with large flap procedures. Closed suction drains, which remain in place for an average of seven days, have been the mainstay treatment for managing fluid in the surgical planes. Drains cause a significant amount of discomfort for our patients and need daily maintenance. Having a minimally invasive therapy that can be used instead of drains will be of great benefit to our patients.
Daly: With TissuGlu, there’s no fluid buildup. Patients are so used to dealing with drains, but they won’t need them. It allows them to get back to a normal life. They can shower quicker and won’t have tubes sticking out of their body. This allows them to sleep better and not worry about damaging anything when they move around, which is quite painful.
SP: Has the plastic surgery community hoped for a product similar to TissuGlu for a while?
Rubin: A minimally invasive technology that can adhere tissue planes and be applied rapidly satisfies an unmet need.
SP: What is the biggest benefit TissuGlu brings to patients? For plastic surgeons?
Rubin: Any product that can eliminate the need for drains will greatly improve patient comfort during the recovery process and eliminate morbidity associated with closed suction drains. As surgeons, we all want our patients to have less discomfort and improved recovery from surgery.
SP: TissuGlu has been in the European Union since 2011. What type of feedback has this product received from surgeons and patients in Europe?
Daly: The feedback over in Europe has been strong. We launched the product in Germany over a three-month period in 2011. In Germany, doctors really had an issue with big flaps. We did some random studies and we’re at the point now that 45 percent of our sales come from doctors of cancer patients. We’re really looking to see growth in Germany; we want to stay focused and get good clinical outcomes there because it’s helpful for us getting FDA approval.
SP: Why would TissuGlu be a better alternative to the typical closed suction drains currently used for large flap procedures?
Daly: It’s really rare that you have a paradigm shift for surgery. It’s like we went from using horse and buggy to the modern day vehicle. It costs a lot of time and money to monitor drains; you have to manage, nurse and physically assist the patient because it’s an open wound inside the body. TissuGlu will be a big cost savings and a game changer.