Shape Memory Medical said today that it won CE Mark approval in the European Union for its Trellix embolic coil for treating vascular abnormalities in brain and peripheral vasculature.
The device is made using the Santa Clara, Calif.-based company’s shape memory polymer, a porous, polymeric material capable of changing from a smaller, catheter-deliverable shape to a “memorized” larger, conformable shape after implantation. Shape Memory Medical said Trellix has been used in 30 neurovascular procedures to date.
“We believe the Trellix embolic coil is a game-changing product, particularly for medium to giant aneurysms, that may offer significant advantages in neurovascular and peripheral vasculature applications. The lack of SMP imaging artifact allows physicians to more easily visualize occlusion during the procedure, which makes it unlike any other embolic coils on the market today. Preclinical results also show rapid conversion to organized thrombus throughout the SMP porous embolic scaffold, followed by collagen deposition, and without chronic active inflammation,” president & CEO Ted Ruppel said in prepared remarks.
“In my experience, the SMP offers significantly higher thrombogenicity than bare-metal platinum coils, which often leads to rapid thrombosis of the lesions. In the majority of the cases, thrombosis continued after the treatment was finished, leading to better results at angiographic follow-up than at the end of the procedure. This is rare, especially for the large and giant aneurysms,” added Dr. Gyula Gal of Denmark’s Odense University Hospital.