In a significant milestone toward obtaining additional key regulatory approvals for the Synergy drug eluting stent system, Boston Scientific Corp. has completed enrollment in the EVOLVE II randomized, controlled clinical trial. The EVOLVE II trial is designed to further assess the safety and effectiveness of the Synergy stent system and support U.S. Food and Drug Administration (FDA) and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.  The Synergy stent uses the market-leading everolimus drug and features an ultra-thin directional polymer coating that is absorbed by the body shortly after drug elution ends at three months.

The injunction against sales of Medtronic's transcatheter heart valves in Germany — issued in a July 12, 2013, court ruling — has gone into effect, according to Edwards Lifesciences Corp. The District Court of Mannheim ruled that Medtronic is infringing Edwards' Spenser patent for transcatheter heart valve technology and issued an injunction prohibiting the sale of CoreValve and CoreValve Evolut systems in Germany, and ordered a recall of these products. Edwards has now provided the bond required to initiate the injunction.