Boston Scientific Initiates Emblem System Trial
Boston Scientific has begun a global, multicenter trial evaluating its Emblem subcutaneous implantable defibrillator for primary prevention of sudden cardiac death in patients with severely reduced cardiac function.
The study arm represents the highest proportion of patients implanted with transvenous ICDs in the U.S. and EU, the Marlborough, Mass., devicemaker said Monday. The trial enrolled its first patient in Dudley, England, and will eventually enroll at least 2,015 across 200 worldwide sites. U.S. enrollment is set for later this summer.
The company will compare the rate and causes of shocks in patient outcomes during an 18-month follow-up.
The Emblem system is CE Marked and FDA-approved. It was launched in the EU in May and became available in the U.S. earlier this month, with a full launch planned for the third quarter of this year. — Jason Scott