For Immediate Release - March 23, 2008

Relay™ NBS Thoracic Stent-Graft.
RELY on a new RELAY treatment option whenever a non bare stent configuration is preferred.

INTRODUCTION

Bolton Medical enhances its portfolio for TEVAR by launching an additional, new Relay™ Thoracic Stent-Graft. The NBS, the abbreviation of Non Bare Stent, is a thoracic stent graft whose proximal end configuration consists of a sinusoidal nitinol stent covered with fabric. (See picture 1)  It will be marketed in addition to the bare stent graft configuration which was launched in 2005 and has been implanted in more than 1000 patients.

RELAY NBS is indicated for the treatment of main thoracic aortic pathologies such as aneurysms, dissections, penetrating ulcers, pseudoaneurysms and intramural haematoma, in adult patients. Therefore Relay™ NBS Thoracic Stent-Graft  uses the technique established by the RELAY TRANSPORT™ delivery system and  represents an alternative device option for patients in which  non bare stent configuration is preferred.

Exact Sealing with a flexible and durable Stent Graft without ballooning

The Relay™ NBS Thoracic Stent-Graft  is comprised of Duralloy™, self-expanding nitinol, stents sutured to polyester vascular graft fabric. Specifically designed thoracic aorta stents are spaced along the length of the graft fabric; thoracic aorta conformability and longitudinal support are provided by a curved nitinol Spiral Support Stut. Platinum/iridium radiopaque markers are placed on the stent-graft to help visualization and ensure very accurate placement. The Relay NBS Thoracic stent-graft is MRI compatible. Undergoing a MRI procedure (at 3-Tesla or less) will not create any hazard or risk to the patient.

Relay™ NBS Thoracic Stent-Graft allows repositioning of the stent graft before deployment for a precise placement and its proximal capture (See picture 2) ensures a controlled release without unexpected stent movements when deploying, no ballooning after deployment is required.

Easy to use 4 step TRANSPORT™ DELIVERY SYSTEM for precision in placement and deployment
The Transport™ delivery system consists of a series of coaxially arranged sheaths and catheters, along with an easy to handle control system. The delivery consists of 4 key steps:

1. 2 stage Advancement: As part of the system a  standard introducer is used to advance and track over a guide wire up to the celiac trunk; in the second stage, an extremely flexible sheath permits tracking even through tortuous and curved portions of the thoracic aorta.

2. Positioning: The delivery system captures the stent graft proximally and allows repositioning until the last moment before deployment to ensure a very precise and accurate placement in the desired deployment site.

3. Deployment: The self-expandable stent-graft is proximally captured and ensures release in the desired deployment point while allowing continued blood flow.

4. Release: After deploying the stent graft, the delivery system is withdrawn from the patient.

Wide range of Diameters AND LENGTHS to allow individual patient treatment

Straight grafts are available in diameters ranging from 26mm to 46mm (2mm step) and tapered grafts are available in diameters ranging from 34mm to 46mm (2mm step), decreasing incrementally by 4mm in the distal portion of the graft.

The Relay™ NBS Thoracic Stent Graft is available in 4 lengths:

• 100mm
• 150mm
• 200mm
• 250mm

COMPANY

Bolton Medical is part of Werfen Group, an international group producing and selling products in the healthcare industry. Bolton Medical’s focus is innovative thoracic endovascular therapies with a new generation of thoracic Stent-Graft called RELAY. RELAY was specifically designed for the thoracic aorta with key benefits in precise placement of the stent and durability through S -curved support strut. The outstanding flexibility of RELAY supports treatment of thoracic aortic pathologhies.