Disappointing enrollment experiences led Medtronic to suspend its Impasse trial, an angiography study of pelvic anatomy as associated with erectile dysfunction, which was intended to include 350 patients.
"Due to the diagnostic screening challenges encountered during the enrollment phase of the ZEN trial, we decided after a great deal of consideration and consultation to suspend our clinical program for vasculogenic erectile dysfunction," Medtronic corporate communications director Joseph McGrath told Heartwire. "Appropriate patient selection proved more difficult than anticipated."
That’s bad news for the clutch of erectile dysfunction patients who have failed drug therapies. Preliminary results from the the older ZEN study had found strong and lasting effects of therapy with Medtronic’s drug-eluting pudendal stent in treatment of ED.
The 1st-in-man ZEN study dissolved after enrolling only 30 of more than 380 screened patients, due to selection issues that left researchers struggling to find participants.
"For us to have a screened failure rate of 92% means that we’re missing the appropriate population," ZEN investigator Dr. Krishna Rocha-Singh told Heartwire.
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