Richard Otto Clinical Quotations

While our clinical trial has been through its third and final scheduled safety review by our independent data monitoring committee and we are nearing completion of enrollment, safety issues always take precedence. Boston Scientific has requested a short period to review these latest (serious adverse events), and we have accommodated their request.

The additional time is primarily attributable to a decrease in the rate of enrollment which began in December and continued through January as well as delays in initiating several additional clinical sites for the study.