An innovative platinum-chromium stent system developed by Boston Scientific Corporation has been granted approval by the US Food and Drug Administration (FDA).

The firm's PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, its next-generation drug-eluting stent (DES) technology, can now be marketed for sale in the US.

Using a platinum-chromium alloy that allows thinner struts and enhanced visibility, the stent is designed for treating patients with coronary artery disease.

Clinical trials have demonstrated the effectiveness of the stent, which has already received CE Mark approval and was launched in Europe in 2009.

"This approval marks an important milestone for Boston Scientific - the beginning of a transition to higher margins on our everolimus stent offering in the US as we shift from the PROMUS Stent to the internally manufactured PROMUSElement Plus Stent System," said Hank Kucheman, chief executive officer.

He added that the approval will deliver an additional $200 million annualised gross margin contribution to the firm.

Sources:

BOSTON SCIENTIFIC RECEIVES FDAAPPROVAL FOR PROMUS ELEMENT™PLUS PLATINUM CHROMIUM STENTSYSTEM (22/11/11)


Boston Scientific's PROMUS Element™ Platinum Chromium Stent Demonstrates Excellent Outcomes in Patients With Long Coronary Lesions (08/11/11)

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