Boston Scientific ($BSX) wrapped up enrollment in a massive pivotal trial for its Synergy drug-eluting coronary stent system in just 9 months, a victory showcasing efficiency and speed despite the study's size and reach.
Launched in November 2012, the EVOLVE II trial enrolled 1,684 patients at 125 sites in countries and regions around the world including the U.S., Canada, Europe, Australia, New Zealand, Japan and Singapore. The Massachusetts medical device giant disclosed the milestone on Sept. 12, noting that researchers will now follow the enrolled patients for 5 years.
Data from EVOLVE II, a randomized, controlled clinical trial, will support eventual approval submissions in the U.S. and Japan to treat atherosclerotic coronary lesions. Regulators will also likely consider data from the original EVOLVE study, a prospective, randomized, single-blind first-in-human use study that compared Synergy to Boston Scientific's own Promus Element. Boston Scientific presented two-year outcomes from that study at the EuroPCR event in Paris earlier this year, showing, in part, no stent blood clots with Synergy over 24 months, plus low rates of target lesion return.
The Synergy stent system has had a CE mark since October 2012, the company notes.
Stent manufacturers are crowding each other, battling to preserve their market share with a number of tactics. They are releasing new stent sizes, pursuing next-generation technology such as stents that dissolve after they do their job, and even pursuing patent fights (see OrbusNeich Medical versus Boston Scientific in Germany). They have plenty to gain, as the number of senior citizens is rising in the U.S. and Europe. And new products, if they catch on, can help reverse stent sales that have been less than stellar for a few years now.
In Boston Scientific's case, executives see Synergy as a next-generation advance that is more flexible and easy to deliver. Coated with the drug everolimus, it also features an ultra-thin directional polymer coating that is absorbed into the body after three months.
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