Natick medical device giant Boston Scientific Corp. has begun enrolling patients in its EVOLVE clinical trial to test the safety of its Synergy coronary stent.
The trial is expected to enroll 291 patients in 35 locations throughout Europe, Australia and New Zealand.
The Synergy stent is made with the same design and same platinum chromium alloy as Boston Scientific’s Promus Element stent, which the Synergy stent is to be compared to in the trial. The Synergy stent also has a bioabsorbable coating that the company noted as aiding blood vessel healing faster and more completely.
The trial, planned for full enrollment by mid-2011, is expected to provide Boston Scientific with more data to use in obtaining CE Mark approval in Europe.
Both the Synergy stent and the Promus stent are investigational devices in the U.S. and have not yet been approved for commercialization here. The Promus stent was approved by European regulators in November.