A woman in Delaware has become the first patient to undergo minimally invasive, endovascular surgery with a polymer-based coil.
The coil, manufactured by Embolization, Inc., is a vascular embolization device intended for arterial and venous embolization in peripheral vasculature. The company received 510(k) clearance from the U.S. Food and Drug Administration for its Nitinol Enhanced Device (NED) this summer.
Mark J. Garcia, M.D., conducted the procedure at EndoVascular Consultants in Wilmington, Delaware. He used the polymer-based coil to treat the patient’s painful pelvic varices and chronic pelvic pain of venous origin, previously referred to pelvic congestion syndrome.
“I see big advantages to using an embolic coil that has little or no artifact, as compared to the current coils and plugs” said Garcia, speaking to the key strength of the NED. Using proprietary shape-memory biocompatible polymers, the NED achieves better vascular occlusion while minimizing artifacts in CT and MRI imaging that occur with traditional metal devices.
“The NED does everything a traditional metal coil does, just with a polymer coil,” added Jim Kasic, who serves as CEO of Embolization. “We are seeing how this development truly does represent the next generation in embolic coils.” He notes that the NED substantially reduces imaging artifact, and is still radiopaque under fluoroscopy even though the CT/MRI imaging artifact is minimal.
