“Freesolve RMS has the potential to provide physicians with an additional treatment option, by reducing the need for permanent implants and potentially offering an alternative to drug-coated balloons in cases where temporary scaffolding is required to support the vessel wall,” the device developer said in a news release.
The catheter-delivered device already has a CE mark and is also available in Asian-Pacific, South American and Middle Eastern countries. The FDA’s Breakthrough Device program accelerates product development and review for devices with potential to more effectively treat or diagnose life-threatening or irreversibly debilitating diseases or conditions.