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news.Boston Scientific has reported CE Mark approval of its Acuity Spiral left ventricular lead, for use with cardiac resynchronization therapy defibrillators and cardiac resynchronization therapy pacemakers, both of which treat heart failure.
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According to the company, Acuity Spiral lead is seventh US or European regulatory approval in the past nine weeks. The Acuity Spiral lead is pending approval by the FDA and is not available for sale in the US.
Fred Colen, executive vice president, operations and technology, Boston Scientific Cardiac Rhythm Management, said: “The ability to place a left ventricular lead precisely where it will stimulate the heart most effectively is a key factor in providing patients with optimal cardiac resynchronization therapy. Acuity Spiral has the smallest lead tip profile in the industry and offers physicians the flexibility to place the lead in veins they may have avoided in the past.”