Adhesys Medical, a wholly-owned subsidiary of Grünenthal Group, received the FDA's Expedited Access Pathway designation for the surgical sealant Vivo.
1. The surgical sealant Vivo is designed to be an adjunct to standard closure techniques in GI procedures to reduce intestinal leakage.
2. "We still face a high unmet medical need in preventing intestinal leakages after gastrointestinal surgeries — life-threatening postoperative complications that affect up to 20 percent of patients," said Gabriel Baertschi, CEO of Grünenthal.
3. The FDA grants EAP designation to technologies and devices that enable better diagnosis or treatment for diseases for which no approved or cleared treatment exists. Technologies and devices that offer significant advantages or existing approved therapies may also receive EAP designation. The EAP designation can lead faster clinical trial implementation by the FDA and shorter review timelines for pre-market approval applications.
More articles on gastroenterology: