The breakthrough device designation allows to use the microspheres for genicular artery embolisation (GAE) of symptomatic knee osteoarthritis
Siemens Healthineers company Varian has secured a breakthrough device designation from the US Food and Drug Administration (FDA) for its Embozene microspheres.
The status allows to use the microspheres for genicular artery embolisation (GAE) of symptomatic knee osteoarthritis.
Embozene is a medical device approved for the embolisation of hypervascular tumours, arteriovenous malformations, uterine fibroids and benign prostatic hyperplasia.
According to the company, the breakthrough status has been granted to Embozene microspheres taking into account their potential to provide enhanced treatment for appropriate patients with osteoarthritis of the knee.
GAE helps in restricting the the inflammatory process by reducing the blood flow to the periarticular tissue of the joints.
In a statement, UCLA Santa Monica interventional radiology director Siddharth Padia said: “GAE is the first minimally invasive procedure that has demonstrated a significant symptom improvement for a prolonged duration.
At present, Dr. Padia is focusing on the commencement of a randomised clinical trial and a 400-patient registry.
Osteoarthritis, the common form of arthritis, is a wear and tear degenerative joint disease that is said to affect the cartilage and surrounding tissues.
In the US, around 14 million individuals are expected to have symptomatic knee osteoarthritis, of which half are affected with advanced knee osteoarthritis.
The management of osteoarthritis of the knee is anticipated to cost between $5.7bn and $15bn per annum to the US healthcare system, said the company.
Varian Interventional Solutions president Dr Frank Facchini said: “GAE holds great promise in providing clinicians with a new, non-invasive treatment option, which may not only ameliorate pain, but reduce the economic burden of this common disease.
“Varian’s investigational program for GAE exemplifies our commitment to investing in our core technologies to determine their potential to treat the world’s most debilitating diseases.”