New use of Boston Scientific devices backed by FDA
A Food and Drug Administration panel unanimously voted for broader use of Boston Scientific’s cardiac resynchronization therapy defibrillators, or CRT-Ds, for patients with heart failure who have no symptoms or only mild symptoms.
CRT-Ds are approved now for treating the most advanced stages of heart failure, but a Boston Scientific study showed they could also benefit healthier patients.
However, the panel said that the use of the devices should only pertain to patients who have a heart problem that causes the left ventricle to contract later than the right ventricle.
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Boston Scientific has received the FDA approval to market its Taxus Liberte long paclitaxel-eluting coronary stent system, a next-generation drug-eluting stent designed for long lesions. At 38mm, Taxus Liberte long stent is the longest available drug-eluting stent (DES). This provides doctors with an option that can potentially reduce the number of stents used in more complex cases, simplifying procedures and reducing costs. The company plans to launch the product in the US in August.
