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CE Mark approval for benign prostatic hyperplasia treatment


2 May, 2013  
Cook Medical has received CE Mark approval for its PVA Foam Embolization Particles to be used for the treatment of symptomatic benign prostatic hyperplasia (BPH).
The product will be shown at this year’s Global Embolization Symposium and Technologies (GEST) conference in Prague, Czech Republic, on 1-4 May.
BPH, also known as prostate enlargement, is a condition in which proliferation occurs in the prostate and cause narrowing or blockages of the urethra. This condition leads to bothersome lower urinary tract symptoms and affects more than 50% of men by the time they reach 60 years of age and is often treated with surgery.(1)
Prostatic artery embolisation (PAE) is a minimally invasive alternative to surgery. In PAE, small particles are injected into the blood vessels that supply the prostate, and the particles block the blood so that it doesn’t reach the overgrown prostatic tissue. Blocking the blood reduces the size of the prostate and relieves symptoms.
Cook Medical’s PVA Foam Embolization Particles can be used during PAE and have shown positive short- and midterm results and provided durable relief of BPH symptoms in the largest global patient trial to date.(1)
“Patients have been our first priority for the past 50 years,” says Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention division. “Consistent with this philosophy, we have worked hard to offer our PVA Foam Embolization particles for PAE as option for the millions of men suffering from symptoms of BPH.”
Reference
  1. Pisco JM, Rio Tinto H, Campos Pinheiro L, et al. Embolisation of prostatic arteries as treatment of moderate to severe lower urinary symptoms (LUTS) secondary to benign hyperplasia: results of short- and mid-term follow-up [Epub ahead of print January 31, 2013]. Eur Radiol. 2013.