Shape Memory Medical's Trellix Embolic Coil System Approved in Europe

October 21, 2019—Shape Memory Medical Inc. announced it has received CE Mark approval for its Trellix embolic coil system, which is intended to obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

The CE Mark-approved indications include:

• Intracranial aneurysms
• Other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae
• Arterial and venous embolizations in the peripheral vasculature

The Trellix device features the company’s shape memory polymer (SMP) technology—a porous polymeric material capable of changing from a smaller catheter-deliverable shape to a “memorized” larger conformable shape in response to the body when implanted.

Gyula Gal, MD, from Odense University Hospital in Odense, Denmark, commented in the announcement, “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.” Dr. Gal will be presenting a selection of his cases at the World Federation of Interventional and Therapeutic Neuroradiology Conference held October 21–24 in Naples, Italy.

Data on the initial cases performed with Trellix were reviewed by Aquilla Turk, DO, from Prisma Healthcare Upstate Network in Greenville, South Carolina. Dr. Turk commented, “The clinical outcomes are similar to those observed with bare platinum coils, but the angiographic outcomes are superior, with a durable occlusion at 6 months.”