The US Food and Drug Administration has cleared Abbott Laboratories’blood test that would help doctors assess traumatic brain injury (TBI), commonly known as concussions, the company said on Tuesday.
The clearance marks the first commercially available laboratory blood test for TBI, according to the company, helping the doctors to rule out need for a CT scan in patients with mild TBI.
TBIs are caused by blow or whiplash to the head and can pose risk of short- and long-term effects that can include impairment of memory and movement.
Abbott already has a plasma test for TBI and was cleared by the FDA in 2021.
The new test measures two indicators in the blood that, in elevated concentrations, are tightly correlated to brain injury, the company said.
Abbott also announced late-breaking data for the TriClip™ transcatheter edge-to-edge repair (TEER) system, a first-of-its-kind minimally invasive device designed specifically for tricuspid heart valve repair. The TRILUMINATE™ Pivotal study evaluates the superiority of TriClip compared to medical therapy in treating patients with severe, symptomatic tricuspid regurgitation (TR) who are at intermediate or greater risk for open-heart surgery.
Key Findings From the TRILUMINATE Pivotal Study
The trial met its composite primary endpoint demonstrating superiority of the TriClip system compared to the control group (win ratio 1.48, p=0.02), primarily driven by improvement in quality of life. Mortality or tricuspid valve surgery and heart failure hospitalizations did not appear different between the groups at one year. Other positive findings include:
Significant reduction in TR grade. Significant reduction in TR to moderate or less (grade < 2) was achieved in 87% of patients with the device at 30 days vs. 4.8% in the control group, with TR reduction sustained and durable at one year.
Significant improvement in quality of life. 50% of patients who received the device achieved at least a 15-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of social abilities, symptoms and quality of life) at one year vs. 26% in the control group.
A strong safety profile. At 30 days, only 1.7% of patients who received the device experienced major adverse events, with no urgent surgery or endocarditis. There were no occurrences of device embolization or device thrombus.
“These TRILUMINATE Pivotal trial results are promising because there have historically been very few treatment options for tricuspid regurgitation, and patients with this condition are often not eligible for open-heart surgery due to multiple co-morbidities or other factors,” said Paul Sorajja, M.D., the Roger L. and Lynn C. Headrick Family Chair of the Valve Science
Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital.
“The trial data and real-world use in Europe from the bRIGHT post-approval study show TriClip’s ability to safely and effectively repair the tricuspid valve in patients and improve their quality of life.”
“These TRILUMINATE Pivotal data show TriClip is the first minimally invasive device therapy for the treatment of tricuspid regurgitation to provide durable improvements in TR severity and quality of life that go beyond taking medication to manage symptoms,” said Michael Dale, senior vice president of Abbott’s structural heart business. “When left unaddressed, TR can be debilitating and life-threatening. By repairing the damage caused by structural heart disease, TriClip G4 and our latest technological innovations are helping people reclaim their lives so they can get back to doing what they love.”
Abbott will also be presenting at ACC late-breaking five-year results from its landmark COAPT™ trial of the MitraClip™ TEER device for functional mitral regurgitation in heart failure.
