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Wednesday August 12, 8:29 am Eastern Time
Company Press Release
SOURCE: Boston Scientific Corporation
Boston Scientific Corporation Receives FDA Approval
For The NIR Coronary Stent
NATICK, Mass., Aug. 12 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX - news) announced today U.S.
Food & Drug Administration (FDA) approval and immediate market release of the NIR ON(TM) Ranger(TM) and the NIR
ON(TM) Ranger(TM) with SOX(TM) over-the-wire balloon expandable premounted coronary stent systems for the treatment
of coronary artery disease. The NIR(TM) stent will be available in lengths of 9, 16, 25 and 32mm and diameters of 2.5, 3.0,
3.5 and 4.0mm.
Coronary stents prop open arteries to facilitate blood flow to the heart. The patented NIR stent is based on a proprietary
transformable geometry(TM) design which allows for flexibility during insertion and rigidity after implantation. The patented
SOX stent securement system is a unique feature that enhances safety in delivering the stent.
The NIRVANA clinical trial served as the basis for FDA approval. NIRVANA included a randomized trial comparing the NIR
stent to a stainless steel balloon expandable stent, as well as registries for abrupt and threatened closure, and the treatment of
saphenous vein grafts. The NIR stent performed well in all aspects of the NIRVANA trial.
The NIR stent was developed and is manufactured by Medinol Ltd. of Tel Aviv, Israel. Boston Scientific has an exclusive
worldwide license to market and distribute the NIR stent.
Pete Nicholas, Chairman and Chief Executive Officer of Boston Scientific, said, ''The introduction of the NIR stent platform in
the U.S. market clearly signals our commitment to leadership in coronary stenting. I would like to congratulate the Medinol
team for their success in designing and developing the stent. In particular, I commend their exceptional management of the
NIRVANA clinical trial.''
Dr. Judith Richter, Chief Executive Officer of Medinol Ltd., said, ''We believe the NIR is the premier coronary stent platform
in the world. In conjunction with our partners at Boston Scientific, we are pleased to make available the NIR stent for the
treatment of patients in the United States.''
Medinol Ltd., a private company, is a pioneer in innovative technology development and in the manufacture of stenting solutions
for a variety of medical applications.
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
More Quotes and News:
Boston Scientific Corp (NYSE:BSX - news)
Related News Categories: medical/pharmaceutical
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