Shape Memory Medical has received the CE mark for its TrelliX embolic coil system. A press release reports that the TrelliX embolic coil system is intended to obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The CE-marked indications include: intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, arterial and venous embolisations in the peripheral vasculature. The press release adds that the TrelliX embolic coil system features proprietary shape memory polymer technology.
To date, according to the press release, the TrelliX embolic coils have been used in more than 30 neurovascular interventions—including aneurysms (seven were large or giant), fistulas, and dissections.
Gyula Gal (Odense University Hospital, Odense, Denmark) says: “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.”
Commenting on this regulatory approval and ongoing clinical usage, Shape Memory Medical’s president and CEO, Ted Ruppel, says: “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 visualise occlusion during the procedure, which makes it unlike any other embolic coils on the market today. Preclinical results also show rapid conversion to organised thrombus throughout the SMP porous embolic scaffold, followed by collagen deposition, and without chronic active inflammation.”
SMP technology was initially researched and developed at Lawrence Livermore National Laboratory and Texas A&M University. Shape Memory Medical was founded to develop and commercialise solutions for a variety of clinical applications using this novel technology. The SMP technology is a porous polymeric material designed to be capable of changing from a smaller, catheter-deliverable shape to a “memorised” larger, conformable shape in response to the body when implanted. Shape Memory Medical continues to develop innovative materials and therapies, including neurovascular applications as well as the peripheral vascular applications.