CeloNova BioSciences, Inc., has announced the extension of CE mark approval of its Embozene™ embolic microspheres to include the treatment of benign prostatic hyperplasia (BPH).
BPH is an enlargement of the prostate causing it to press against the urethra and interfere with the passage of urine out of the body. Symptoms can include frequent urination, weak urine stream and a persistent feeling of having to urinate. BPH is a common condition in men, which increases with age. Symptomatic BPH typically occurs in the sixth and seventh decades of a man’s life, reaching an estimated 40% of men in their 70s.
The current surgical standard of care is the transurethral resection of the prostate (TURP), although this newly extended approval means another procedure, Prostatic Artery Embolization (PAE), can achieve similar results through less invasive means.
CeloNova’s Embozene microspheres first received a CE mark in November 2005 and have been successfully used in thousands of procedures, including Interventional Cardiology, Oncology and Endovascular use.
“The symptoms of benign prostatic hyperplasia can cause significant impact in a patient’s quality of life and prostatic artery embolization offers a safe and effective treatment option for men,” said Prof. Dr. Ulf Teichgraeber, Director of Radiology at University Hospital, Jena, Germany.
“The expanded indication in Europe for benign prostatic hyperplasia provides continuing support to interventional radiologists and urologists working in tandem to offer men relief from the symptoms of BPH,” said Jörg Menten, President International of CeloNova BioSciences.
“Embozene microspheres go through a sophisticated manufacturing process that ensures precisely calibrated size and shape,” said Jane Ren, Ph.D., Chief Technology Officer of CeloNova BioSciences. “The Embozene microspheres are uniquely designed to give the interventional radiologist the highest level of confidence in performing the procedure.”
Source: Business Wire