Cartiva announced that it has submitted the first module of its PMA application for its less invasive alternative to fusion surgery for osteoarthritis of the first metatarsophalangeal (MTP) joint, which connects the big toe to the foot.
Its Cartiva Synthetic Cartilage Implant is a biomaterial that acts as a substitute to cartilage due to its low friction, compressibility and durability, according to the company's statement. It could be approved as early as the second half of 2015. Cartiva says the product is being tested in the randomized, 236-patient Motion pivotal trial, scheduled to be completed in Q4 2014.
"The Motion study is the largest randomized study ever undertaken for great toe arthritis. As such, it will provide the highest level of clinical evidence ever published," said CEO Timothy Patrick in a statement.
"Cartiva SCI has the potential to fill a large unmet need for a less invasive treatment that preserves motion and minimizes bone loss," he said.
According to the company, more than two million Americans have osteoarthritis in the MTP joint. Cartiva SCI restores natural movement of the joint and doesn't require the long rehabilitation period that follows joint fusion surgery, according to the statement.
The company's website says the product is available in Canada, Europe and South America.
- read the release