The owner of Germany’s Adhesys Medical, Grünenthal, said today it won FDA expedited access pathway designation for its Vivo surgical sealant, designed to be an adjunct to standard closure techniques in gastrointestinal procedures to reduce intestinal leakage.
The Germany-based company said that Vivo is a candidate from the company’s development-pipeline of surgical sealants.
“We are delighted about the FDA’s positive recognition of Vivo. We still face a high unmet medical need in preventing intestinal leakages after gastrointestinal surgeries – life-threatening postoperative complications that affect up to 20% of patients. We believe Vivo may become a valuable adjunct to current closure techniques and in combination with these provide a much higher safety standard for patients,” Grünenthal CEO Gabriel Baertschi said in a press release.
“Obtaining EAP designation brings further momentum to the development of our surgical sealants, for which we have a unique technology platform at hand. Its combination of features is unparalleled and comprises bonding strength, fast sealing and flexibility. Moreover, the faster, more predictive and cost-conscious development of devices and technologies improves the risk profile of our portfolio,” Grünenthal chief scientific officer Klaus-Dieter Langner said in prepared remarks.
Adhesys said last month that it won CE Mark approval in the European Union for another one of its surgical sealants, the Flix topical skin adhesive designed for surgery.
