This nitinol vascular embolization device has another shape memory material up its sleeve

Embolization Inc. says its new Nitinol Enhanced Device (NED) for vascular embolization uses another shape-memory material that makes it the only polymer-based coil on the market.

The minimally invasive system recently won FDA 510(k) clearance for arterial and venous embolization in the peripheral vasculature, but not neurovascular use.

“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,” the company said in a news release.

The NED system includes a delivery microcatheter and permanent implants for framing and packing to block the blood vessel.

“The framing implant is deployed first to form the initial pack and create a backing for additional implants to be deployed in accordance with physician discretion,” the company explained in its FDA submission. “The deployment of the framing implant is followed by the deployment of packing implants, the quantity of which is determined by the physician based on vessel size and occlusion. The physician also has the option to finish the implant pack with another framing implant.”

The framing implants are made of: nitinol; an unidentified radiopaque polymer; polyethylene terephthalate (PET, for the atraumatic tip); and ultra-high-molecular-weight polyethylene (UHMWPE).

UHMWPE has shape memory properties and is used in the external braid of the NED’s framing implants and the packing implants. Those packing implants also have PET tips and use a radiopaque polymer with thrombogenic tails, but not nitinol.

Boston Scientific’s Interlock-18 Fibered IDC Occlusion System, which Embolization Inc. listed as a predicate for its device, uses only platinum with thrombogenic tails for its implant.

“Our pre-clinical work has shown that the coils have substantially reduced imaging artifact, significantly outperforming competitive devices,” Embolization Inc. CEO Jim Kasic said in the news release. “… With fewer devices per procedure, lower recanalization rates and lower manufacturing costs, I believe the Embolization coil will substantially replace existing metal options.”

Embolization said animal testing has shown advantages of its non-metal coils including “reduction in shadowing or obscuration on imaging scans, easier repeat embolizations, faster, more reliable embolization [and] simplicity and ease of use, through a patented 1 mm diameter implantation tool.”

The NED also uses nitinol in the implant pusher, which the company describes as “a 180-cm-long, 0.022-in. diameter single super-elastic nitinol wire with a 30 cm PTFE jacket and a platinum/iridium radiopaque marker near its distal end [that] allows the physician to reposition the NED to ensure preferred vessel positioning prior to detachment.”

The Boulder, Colorado-based device developer said it worked with medtech consulting firm Boulder iQ and sister company Boulder Regulatory and Quality on the project. All three share the same address and are owned and/or led by Kasic, who also led now-defunct device developer EndoShape Inc. as CEO while it worked on the same technology.

In 2024, Stone Bridge Ventures recapitalized and renamed EndoShape, Kasic said in an email.

“As Embolization Inc., the company completed the development of the shape-memory polymer,” he said.

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