Boston Scientific drug-eluting stent systems win FDA nod

22 February 2012 (Last Updated February 22nd, 2012 18:30)

The US Food and Drug Administration (FDA) approved Boston Scientific's Ion paclitaxel-eluting platinum chromium coronary stent system and Taxus Liberte paclitaxel-eluting coronary stent system used to treat patients with acute myocardial infarction (AMI).

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The US Food and Drug Administration (FDA) approved Boston Scientific's Ion paclitaxel-eluting platinum chromium coronary stent system and Taxus Liberte paclitaxel-eluting coronary stent system used to treat patients with acute myocardial infarction (AMI).

The Ion stent system features a platinum chromium (PtCr) alloy designed specifically for coronary stenting and intended to improve the acute performance of coronary stent implantation in the treatment of coronary artery disease.

The device's approval is backed by the global Horizons-AMI trial which randomised 3,006 patients to receive either drug-eluting stents or bare-metal stents for the treatment of acute myocardial infarction (AMI) or heart attack.

Boston Scientific Global chief medical officer Keith Dawkins said clinical data from the Horizons-AMI trial showed that, in patients with AMI, paclitaxel-eluting stents were superior in efficacy to bare-metal stents, reducing clinical and angiographic restenosis compared to bare-metal stents, demonstrating a comparable safety profile after three years.

"We are proud that our investments in randomised trials such as Horizons-AMI have led to the approval of products to treat a broader range of patients with coronary artery disease," Dawkins added.

"The AMI indication is a testament to our long-term commitment to innovation and leading clinical science in support of advanced DES technologies."

Boston Scientific CEO Hank Kucheman said the new indication for heart attack patients should give US physicians the ability to treat the high-risk group with their paclitaxel-eluting stent technology.

"The AMI indication reinforces the safety and effectiveness of the Ion and Taxus Liberte paclitaxel-eluting stents in treating challenging patients and lesions in both clinical and real-world practice," Kucheman added.

"This innovative platinum chromium stent has been very well received since its US launch last year based on its exceptional visibility, radial strength and deliverability."

According to the American Heart Association there are more than 1.2 million new and recurrent cases of heart attacks each year, with approximately 34% resulting in death. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a number of interventional medical specialties.

Caption: Boston Scientific's Corporate Headquarters in Natick, Massachusetts, US. Image: Boston Scientific.