June 25, 2025

Embolization, Inc., is the latest company to receive 510(k) clearance with the development and regulatory work provided by Boulder iQ and its sister company, Boulder Regulatory and Quality.

Embolization’s Nitinol Enhanced Device (NED) is a vascular embolization device intended for arterial and venous embolization in peripheral vasculature. Using proprietary shape-memory biocompatible polymers, Embolization’s coil devices achieve better vascular occlusion while minimizing artifacts in CT and MRI imaging that occur with traditional metal devices.

Boulder iQ leadership, facilities
Under the leadership of Jim Kasic – who also serves as president and CEO of Boulder iQ – Embolization moved its operations to the Boulder iQ facility. The move expanded access to resources, increased flexibility during product development and reduced costs. Embolization was able to use the Boulder iQ cleanroom and tap into the expertise of in-house engineering and production teams.

Boulder Regulatory and Quality streamlined the FDA submission process, while Boulder Sterilization handled the ethylene oxide sterilization for the device.

Bringing a true next-generation device to market
Embolization’s development represents the next generation in embolic coils, says Kasic. “The 510(k) clearance – which gives the company the ability to market the device – is a defining moment and major step forward in bringing this important device to the medical communityt,” he says. “The project is an excellent example of how the expertise and know-how of Boulder iQ and its sister companies can work to bring a device to market.”

Vascular embolization is a minimally invasive procedure where a physician intentionally blocks a blood vessel using tiny materials such as coils, particles or glue. This stops bleeding, reduces blood flow to tumors, or prevents damage from abnormal blood vessels, and is often used instead of surgery because it’s safer, quicker to recover from and very precise.

Jeremy Anderson, Director of Business Development. Email Jeremy.