The University of Michigan and Baxter have announced the signing of a licensing agreement for the expected global marketing and distribution of the arterial everter, a surgical device that could make it quicker and easier to connect arteries in complicated procedures. Financial terms of the agreement were not disclosed.
“We are actively looking for technology partnerships to bring to market innovative solutions that solve challenges in the operating room,” says Michael Campbell, vice president of Baxter’s microsurgery business. “We are excited to work with the experts at the University of Michigan and license this promising new technology that could lead to a meaningful impact for microsurgeons.”
Developed by the University of Michigan, the everter device first began as a project in an undergraduate class at Michigan Engineering. The device has the potential to assist in complicated procedures such as reconstructing a breast after mastectomy, or a severely injured leg after a car accident. It looks like a thin silicone pen with a flexible steel spine.
“The device simplifies what can be a technically challenging operation,” says Adeyiza Momoh, associate professor of surgery at the U-M Medical School. “If I can shave off an hour from my operative time, patients stand to benefit from being under anesthesia for a shorter period of time, and the health system as a whole benefits because we are spending less time in the OR.”
A new, preliminary study, which was recently published in the Journal of Reconstructive Microsurgery, suggests that the device could reduce a 20-minute process of connecting arteries to just five minutes, with the possibility of not requiring a surgical microscope. With surgeons often connecting more than one artery in a patient, the time saved adds up.
The device would work as an accessory to the GEM Microvascular Anastomotic Coupler system, which is a tool currently available to connect blood vessels. GEM is made by Synovis Micro Companies Alliance Inc., a wholly owned subsidiary of global medical products company Baxter International Inc.
The unique aspect of the everter device is that it is designed to help surgeons spread the thicker arterial walls over the rings of the GEM coupler, which currently works well on veins but can be hard to maneuver on the more muscular walls of arteries.
Paul Cederna, professor of biomedical engineering and chief of the Section of Plastic Surgery at the U-M Medical School, is familiar with the process of hand-sewing tiny, 1- to 3-millimeter arteries in complex tissue transfers and envisioned that this might be an ideal problem for U-M’s engineering design students. Cederna brought the challenge to Mechanical Engineering 450, a senior-level course he was co-teaching with Albert Shih, professor of mechanical engineering.
Jeffrey Plott, a research fellow in mechanical engineering who was then a doctoral student in Shih’s lab, served as the product development mentor on the project.
“The students developed great initial breakthroughs in function,” says Plott. “The initial designs were too complicated for ideal use in the operating room. Building on that early success, we were able to work with surgeons to streamline the concept and turn it into a potential commercial product.”
The Coulter Translational Research Partnership Program, housed in U-M’s Department of Biomedical Engineering, played a key role in taking the device from the lab to the marketplace by providing funding for product design and testing.
“The everter is an example of how the entrepreneurial ecosystem at U-M supports biomedical innovation,” says Bryce Pilz, director of licensing for the U-M Office of Technology Transfer. “Projects at U-M benefit from schools that are top in their respective areas, have great researchers, and have also invested heavily in commercializing research.”
Baxter still has to file for FDA and other approvals before the device can be used in surgeries.