Both picked up FDA approvals for the treatment of symptomatic subacute and chronic subdural hematoma (cSDH) as an adjunct to surgery.
Earlier this month, Medtronic said the FDA granted the indication for its Onyx liquid embolic system (LES) in the U.S. Onyx can now provide embolization of the middle meningeal artery (MMA) as an adjunct for surgery in treating SDH/cSDH.
Onyx LES, an ethylene vinyl alcohol (EVOH) copolymer, provides complete filling and distal penetration of peripheral lesions. It is delivered through a microcatheter under fluoroscopic control. The system’s non-adhesive properties enable more distal nidus embolization without the risk of catheter entrapment. Additionally, higher viscosities allow for controlled deployment. Medtronic also has a study underway for Onyx LES in the embolization of arterial hemorrhage in the peripheral vasculature.
The EMBOLISE trial compared MMA embolization using Onyx with surgical management alone. Results shared last year demonstrated a 63% decrease in recurrence and reoperation when combined with surgery. Investigators also reported no device-related adverse events up to 180 days and no deaths attributed to Onyx or the procedure.
“This expansion reflects Medtronic’s ongoing commitment to innovation, grounded in evidence and designed around safety and outcomes,” Medtronic said in a news release. “Our dedicated Principal Investigators and research teams continue to analyze the EMBOLISE trial data, providing further insights to advance cSDH treatment.”
Johnson & Johnson MedTech gets the nod for its own LES
About 10 days after Medtronic’s FDA nod, J&J MedTech said it received an expanded indication from the FDA for its TruFill n-BCA LES for the same treatment in cSDH. The company said its minimally invasive, endovascular approach targets smaller brain vessels to contribute to hematoma persistence and regrowth in cSDH, which is often caused by minor head trauma that leads to bleeding between the dura and arachnoid membranes.
J&J MedTech says TruFill n-BCA has been “a trusted solution in neurovascular embolization” for more than 25 years. It previously offered support for patients with arteriovenous malformations, garnering FDA approval in 2000.
Expanded FDA indication brings TruFill n-BCA to cSDH on the back of the company’s MEMBRANE clinical trial. It demonstrated that TruFill n-BCA is superior in effectiveness compared to the standard of care. The study also showed that the option proved safe for treating cSDH.
“This approval reinforces the enduring value of TRUFILL n-BCA and our commitment to delivering innovative technologies that improve outcomes for patients and address complex neurovascular conditions,” said Christian Cuzick, President, Worldwide Neurovascular, Johnson & Johnson MedTech.
