Cook Medical Gains CE Mark for PVA Foam Embolization Particles to Treat Benign Prostatic Hyperplasia

May 3, 2013—Cook Medical (Bloomington, IN) announced that it has received CE Mark approval for its PVA foam embolization particles for the treatment of symptomatic benign prostatic hyperplasia (BPH). The company is introducing the product at the GEST 2013: Global Embolization Symposium and Technologies conference, May 1 through 4, in Prague, Czech Republic.

Cook noted that with prostatic artery embolization (PAE) as a minimally invasive alternative to surgery for the treatment of BPH, small particles are injected into the blood vessels that supply the prostate, blocking blood flow so that it does not 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 the company notes that they have shown positive short- and midterm results and provided durable relief of BPH symptoms in the largest global patient trial to date. These data were published by Joao Martins Pisco, MD, et al, online ahead of print in European Radiology on January 31, 2013.

At GEST, Nigel Hacking, MD, a consultant radiologist at University Hospital in Southampton, United Kingdom, discussed his experiences performing PAE with PVA foam particles in a 20-patient pilot study, and Hugo Rio Tinto, MD, an interventional radiologist at Hospital Saint Louis in Lisbon, Portugal, presented a tailored approach to prostatic artery access.

"This is a really serious health issue for men over about the age of 50, typically presenting in a number of lower urinary tract symptoms," explained Dr. Hacking in an interview with Endovascular Today. "These include difficulties passing urine, slow urinary flow, hesitancy, difficulty starting, urgency, frequency, and the need to get up to pass urine several times at night. All of these can eventually add up to be intolerable for the patient."

Using Cook's PVA foam particles in the study, Dr. Hacking described the safety profile as being excellent, with very good results observed to date. "We're using a small quantity of one of the smallest PVA particles, measuring 100 and 200 µm in diameter. We're finding it's getting distal and it's not occluding catheters, which has always been a worry with some of the larger PVA particles. With enough dilution, we haven't had any microcatheter blockage."

Although the data from Dr. Hacking's study are not yet fully available, initial results at 3 months have been favorable, with improvements comparable to those seen in other recent European experiences. These include an approximately 80% symptomatic improvement to date and double-digit drops in International Prostate Symptom Score (IPSS), which Dr. Hacking notes compare favorably to single-digit IPSS reductions after drug therapy. Prostate volume reduction has been observed at 25% on average at 3 months. Patients in the study will continue to be monitored to determine long-term efficacy, with follow-up evaluations scheduled at 1, 3, 6, and 12 months.

Look for an expanded interview with Dr. Hacking on interventional BPH therapy in an upcoming edition of Endovascular Today. Additionally, through Cook's Vista collaboration and learning program, the company is offering training courses for physicians who are interested in PAE.