The approval comes shortly after the company inked an exclusive distribution agreement with Ecuadorian medical device distributor Cardiobene, Israel-based InspireMD said. Both companies have worked together to secure regulatory approvals in the country, InspireMD added.
“We have been working with key opinion leaders as well as the top hospitals in the country in anticipation of these approvals in order to start selling the products. The clinical advantages for both of these products is compelling and we expect our physicians to start using the products very quickly,” Cardiobene’s Patricio Erazo said in a press release.
Sale of both devices is slated to begin immediately, InspireMD said.
“This approval enhances our footprint across Latin America. We are very excited to work with Cardiobene, one of the most successful distributors of endovascular products in Ecuador,” InspireMD chief commercial officer Agustin Gago said in a prepared statement.
In late March, InspireMD said it won regulatory approval from Peru’s Ministry of Health for its CGuard embolic prevention system and MGuard Prime.