Boston Scientific Expects Synergy To Dominate Drug-Eluting Stents In US
Boston Scientific wants to expand the lead against other stents used by interventional cardiologists with the launch of its bioabsorbable Synergy drug-eluting stent. The company expects it will become the workhorse of the industry to handle a broad range of surgeries to treat coronary artery disease.
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The company announced July 20 the start of its 30-patient, single-arm FAST study assessing its everolimus-eluting scaffold system, but executives says Boston Scientific will be closely considering whether the system warrants long-term investment, considering the promise of its Synergy stent.
The firm's FDA submission for the first-in-class bioresorbable vascular scaffold was completed in the second quarter, a spokesman said. That appears to be ahead of a prior estimate to submit by the end of 2015.
The US FDA says as long as the EUA-authorized tests provide a notification with validation data and procedural information, they can be used for pooled serial screening before additional review.