להלן הודעתה של חברת ביוטרוניק הנוגעת לקבלת סימון ה-CE לסדרת הסטנטים החדשים מסדרת Lekton Motion , ו-Motion Mega
New stents specifically designed for the treatment of small vessel and large vessel lesions Bulach, Switzerland – June 11, 2004 –
BIOTRONIK GmbH & Co. KG announced that it has received the CE mark for its new Motion Petite and Motion Mega coronary stents, designed specifically for small and large coronary arteries.
The addition of these stents as part of the Lekton Motion stent family will allow for the treatment of coronary arteries from 2.0 mm to 5.50 mm in size. The company plans to launch the stents immediately in all international markets.
The Lekton Motion stent system has demonstrated excellent trackability and deliverability since its launch in May, 2003. The Lekton Motion family combines an innovative stent design for unbeatable flexibility and a state-of-the-art delivery system for excellent access to distal and tortuous anatomy. The Motion Mega and Motion Petite will extend that performance to a wider range of coronary vessel sizes.
“The new design associates ultra thin struts, one of the lowest profiles on the market, and side-branch preservation, which is the reason for the great success of the BIOTRONIK Motion stent family in the marketplace,” said Dr. Claus Martini, CEO of BIOTRONIK Vascular Intervention. “The fusion between the clinical advantages of these features, as proven in a number of international studies, and our passive coating constitute a winning combination.” An international registry will be conducted with the new Lekton Motion Petite system in many markets; this follows a Lekton Motion Master study that was completed in 2003.
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