Elutax Intracranial Control

Pauwelsstrasse 19, 52074 Aachen, Tel. +49-(0)241-97900905, Fax +49-(0)241-97900907, E-Mail: [email protected]

Aachen, Germany, 04.04.2009

First in man use of a Drug eluting Balloon for treatment of intracranial Stenosis WITH ANGIOGRAPHIC FOLLOW-UP AFTER 5 MONTHS

Symptomatic intracranial stenoses have a high risk for a recurrent stroke if treated medically. Although angioplasty and stent placement are proposed treatment options, data shows a poor long-term outcome. Mortality rate when untreated is more than 20% in a period of 24 months. Prof. Juergen Reul of Beta Klinik, Bonn, Germany, used successfully and at the first time in the world the Elutax Balloon catheter in a case of triple A. basilaris stenosis. The contra lateral artery was already occluded. Before treatment:

Due to the triple-lesions anatomy a stent placement was not the first option, as the tortuosity of the vessel could jeopardize the successful placement.

During Intervention of Elutax:

After treatment with Elutax:

The triple restenosis is resolved and the blood flow is restored successfully.

Angiographic Control after 5 month:

The severe triple stenosis shows no sign of restenosis.

Patient Monitoring with Magnetic Resonance:

Severe stenosis could be detected by Magnetic Resonance

Before intervention:

Control after 6 Months after Elutax Treatment:

Background: Elutax is developed especially for small vessels. The balloon is coated with 2 microgram/mm² pure Paclitaxel. As there is no stent mounted on the balloon, the pushability and the positioning of the device are facilitated compared to a balloon catheter with a stent. The main cause of stenotic lesions is caused by neointimal cell hyperplasia. Local administration of lipophilic paclitaxel compounds inhibits the proliferation of such cells for a long period. About Aachen Resonance: Aachen Resonance is a leading European manufacturer of medical technology with a worldwide market presence. The company offers a complete line of products for treatment and advanced therapy support in vascular intervention, working in close cooperation with the University of Technology in Aachen and the BETA Klinik, Bonn. Its main focus is developing new devices with improved biocompatibility The field of vascular intervention consists of balloon catheters, stents, drug eluting stents and drug eluting balloons for coronary and peripheral applications. The company invests heavily in research and development, and is pursuing important, future-oriented approaches to cardiovascular therapy. Currently, Aachen Resonance maintains three headquarters in Europe for research, development and manufacturing. Aachen Resonance is market leader in Europe for Drug eluting balloons. Contact address: Dr. Alexander Ruebben, MBA, CEO Aachen Resonance GmbH Pauwelsstrasse 19 D-52074 Aachen Germany Tel. 0049 241 97900905 Fax. 0049 241 97900907 www.aachen-resonance.com Email: [email protected]