Earlier this month, Medtronic received a new approval from the FDA for its decades-old liquid embolic system, extending its use to treat certain kinds of internal brain bleeds. Now, Johnson & Johnson MedTech has claimed the same green light.
J&J’s Trufill n-BCA system, short for n-butyl cyanoacrylate, starts as a liquid solution but solidifies once it comes into contact with blood and tissue. It was originally approved by the FDA in 2000 to help cut off blood flow to dangerous arteriovenous malformations in the brain, via delivery by a catheter.
Medtronic’s Onyx injection works similarly but employs a different mixture of ethylene vinyl alcohol copolymer dissolved in dimethyl sulfoxide. That approach was first approved in 2005.
The FDA has now expanded the labels of both to include their use during surgeries to treat subdural hematomas, including chronic and subacute cases, by blocking the feeding middle meningeal artery.
These bleeds within the brain’s outer membranes are typically caused by minor head trauma, including among older adults and those taking blood thinners. Surgery is the standard approach, but between 10% and 20% of patients will see the bleeding return over time.
“There is an unmet need for new treatment options for chronic subdural hematoma, particularly for patients at risk of recurrence or complications from surgery,” Chris Kellner, M.D., director of Mount Sinai’s cerebrovascular and intercerebral hemorrhage programs, who also served as an investigator in J&J’s clinical trial, said in the company’s Thursday announcement.
The randomized, controlled Membrane study explored the use of Trufill’s middle meningeal artery embolization in 376 participants and found it outperformed standard-of-care techniques for treating chronic subdural hematomas in measures of recurrence and retreatment after six months. The study also demonstrated the safety of the procedure, according to the company.
Previously, a meta-analysis published in the journal Neurosurgery spanning more than 450 studies and 103,000 cases over 20 years—and including a variety of treatments and surgical approaches—found that embolization of the middle meningeal artery dropped recurrence rates down to 2.3%, compared to 10.8% in open procedures to drain the bleed and 16.7% with drug-based therapies.
“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,” Christian Cuzick, J&J MedTech’s worldwide neurovascular president, said in this week’s announcement.