RevMedica’s Endo Stapling Platform Accepted into FDA’s STeP Program

RevMedica’s Endo Stapling Platform has been accepted into the U.S. Food and Drug Administration’s (FDA’s) Safer Technologies Program (STeP).

Acceptance into the FDA’s STeP is reserved for “medical devices that are reasonably expected to significantly improve the safety of currently available treatments.” The program aims to expedite development, assessment, and regulatory review by way of interactive communication with the FDA as the program goes on.

“The STeP designation offers additional validation of the unique advantages of our stapling platform,” said RevMedica CEO Tom Wenchell. “This is the product of many years spent listening to surgeons describe their need for objective, real-time data currently lacking in today’s stapling devices. We are fortunate to have such an experienced team of surgical stapling experts on staff to make this product a reality.”

The company also bolstered its intellectual property portfolio by issuance of five new U.S. patents, bringing its total to 20 U.S. and five foreign issued patents.

“We continue to build a strong foundation to bolster our unique offering and will continue to protect these advancements in the U.S. and abroad,” said Wenchell.

RevMedica aims to revolutionize how surgeons approach soft tissue management. The company focuses on optimizing clinical decision-making and elevating patient safety by developing cost-effective, environmentally-friendly surgical systems.