ZEN Results Raise Early Hopes For DES In Erectile Dysfunction

Thirty-day and three-month results from an eagerly awaited first trial to test a drug-eluting stent (DES) for the treatment of erectile dysfunction suggest that this novel use for a DES is safe and associated with significant improvement in erectile function and satisfaction. But the trial also encountered logistical problems related to the uncharted complex terrain of the pelvic vasculature, meaning that the next trial in this arena is going to take a step back.

Medtronic released preliminary study data concluding that their drug-eluting stents help men with erectile dysfunction who do not respond to treatment with drugs. The medical device giant conducted a study in 30 men and the results of the first three months were reported by Dr. Jason Rogers of UC Davis Medical Center at the VIVA 11 conference in Las Vegas this week.

The zotarolimus coated stents were placed into the internal pudendal artery, which accounts for the blood supply to the penis. This intervention opened the blood vessel and improved blood flow towards the penis. The treated men showed improvements on the Index of Erectile Dysfunction scale and there were no adverse events. Most important: the treated men were excited and happy with the treatment and its effects. Ultrasound tests also confirmed that the blood flow improved significantly after the placement of the stent at the beginning of the study.

Dr. Rogers announced that a new trial will be launched to investigate the pelvic anatomy using angiography in men with and without erectile dysfunction. The trial will not involve stenting. This is to better understand how the stents led to such an improvement, and how they can be safely delivered. Rogers also stated it could be several years before Medtronic undertakes a much larger late-stage trial. It will be interesting to see whether this newly arisen technique will be able to keep standing in the combat against erectile dysfunction.

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