US-based Shape Memory Medical has received CE mark for its TrelliX Embolic Coil System, which helps to obstruct blood flow in case of vascular abnormalities of the neurovascular and peripheral vasculature.
Featuring shape memory polymer (SMP) technology, the CE-marked indications for the system include intracranial aneurysms, as well as other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and arterial and venous embolisations in the peripheral vasculature.
The system has so far been used in more than 30 neurovascular surgeries, including aneurysms, fistulas and dissections.
Commenting on the ongoing clinical usage and regulatory approval, Shape Memory medical president and CEO Ted Ruppel said: “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 artefact allows physicians to more easily visualise occlusion during the procedure, which makes it unlike any other embolic coils on the market.
“Preclinical results also show rapid conversion to organised thrombus throughout the SMP porous embolic scaffold, followed by collagen deposition and without chronic active inflammation.”
Initially researched and developed at Texas A&M University and Lawrence Livermore National Laboratory, the SMP technology is based on porous polymeric materials that can transform from a smaller, catheter-deliverable shape to a larger, conformable shape in the body once implanted.
Odense University Hospital senior consultant Gyula Gal said: “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.”
Alongside licences to 30 issued patents for its SMP technology, Sharp Memory has 40 patent applications in the process, alongside several FDA-approved and CE-marked products in use.