US-based Boston Scientific has completed the patient enrolment in the EVOLVE II clinical trial, designed to assess the safety and effectiveness of SYNERGY stent system and support the US Food and Drug Administration and Japanese regulatory approvals for atherosclerotic coronary lesions treatment.
The EVOLVE II randomized, controlled clinical trial was launched in November 2012 and currently 1,684 patients have been enrolled in the trial at 125 sites globally, including the US, Canada, Europe, Australia, New Zealand, Japan and Singapore.
Patients enrolled in this clinical trial will be followed till 2018.
The EVOLVE II clinical trial is based on the EVOLVE study, a prospective, randomized, single-blind, first-in-human use study comparing the SYNERGY stent system to the PROMUS Element stent system.
The SYNERGY stent system uses everolimus drug and has an ultra-thin directional polymer coating, while PROMUS Element stent system uses a durable polymer coating.
The polymer coating in the SYNERGY stent system will be absorbed by the body shortly after drug elution stops at three months.
Boston Scientific interventional cardiology president Kevin Ballinger noted completing enrollment of EVOLVE II in nine months is just one example of how the company and the physician community are advancing cardiology together.
"The SYNERGY product underscores our ongoing commitment to delivering meaningful innovation to the interventional cardiology community and reinforces our position as a global leader in medical devices,"Ballinger added.