Health Canada has granted approval to AcuFocus to market and sell the Kamra small-aperture corneal inlay in Canada, according to a news release.
The inlay is designed to restore near and intermediate vision in presbyopic patients.
AcuFocus also announced it has received a certificate of free sale, which will open additional markets in Argentina, the Russian Federation, Venezuela, Peru, Mexico, India and Colombia, the release said.
“We are striving to make the Kamra inlay available to presbyopes around the world,” Ed Peterson, AcuFocus president and CEO, said in the release. “With our CE mark, certificate of free sale and now approval from Health Canada, we are one step closer to achieving that goal.”
Sigmacon Medical will distribute the device in Canada, the release said. The inlay is available in 40 countries worldwide, and more than 15,000 inlays have been implanted.
AcuFocus will submit the inlay for approval by the U.S. Food and Drug Administration in the fourth quarter, according to the release.