Boston Scientific receives FDA approval for coronary stent systems

Boston Scientific Corporation recently announced that it has received U.S. Food and Drug Administration (FDA) approval to market three NIR® coronary stent systems, completing FDA approval for the NIR Elite family of stent systems. The company plans to launch all three products this week.

The approvals are for the NIR Elite Monorail Stent System, the NIR Elite Over-The -Wire Stent System, and the NIROYAL Elite Over-The- Wire Stent System. The NIROYAL Elite Monorail Stent System received final FDA approval earlier this month and was launched at that time.

The NIR Elite systems feature a stainless steel finish, while the NIROYAL Elite systems are gold-plated.
The proven design of the NIR family of stent systems provides excellent angiographic and long-term clinical results. All NIR Elite stent systems share a number of common features, including:

• SOX system technology, which enhances deliverability by providing complete stent edge protection. The technology also aids in efficient lesion crossing, and creates a unique "ends-last" deployment mode, which initiates from the center of the stent and concludes at the ends.
  
• Conformer stent closed-cell geometry for outstanding vessel support.
  
• DynaLEAP balloon material, which is designed for stent deployment and post-dilatation. The system has minimal balloon overhang which focuses expansion force on the stented area.

The four systems are now approved for all six lengths: 9, 12, 15, 18, 25 and 31 mm, and for all four diameters: 2.5, 3.0, 3.5 and 4.0 mm.

"These three approvals complete the approval cycle for the NIR Elite family of coronary stents," said Paul LaViolette, Boston Scientific Senior Vice President and Group President of Cardiovascular. "They build on the momentum created earlier this month by the approval of the NIROYAL Elite Monorail System. We are now able to offer physicians an extremely broad range of features and delivery systems to accommodate a wide array of preferences and indications in coronary stenting. These approvals represent a major opportunity both for Boston Scientific as well as for our customers and their patients."

The NIR stent was developed and is manufactured by Medinol Ltd., Jerusalem, Israel. Boston Scientific has an exclusive worldwide license to market and distribute the NIR stent.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties

Source: Boston Scientific Corporation