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For Immediate Release - March 3rd, 2009

2000 Patient already treated successfully with RELAY and RELAY NBS Thoracic Stent-Grafts.
Bolton Medical proudly announces a major milestone for RELAY and RELAY NBS Thoracic Stent Grafts by achieving 2000 patients treated worldwide.

On January 29th in Germany the 2000th RELAY patient, a 48-year-old male, was diagnosed with a Traumatic Rupture of his thoracic aorta. The patient was treated with a 22 mm straight RELAY device, the lowest diameter available of the brand.

This accomplishment reinforces the growth of RELAY in the European market where, in the last published market data report, has obtained an 11.6% market share (EVEM Period Q3 2008, Biba Medical).

Overall, since the CE Marking of the device in June 2005, RELAY has obtained an average of 1,22 devices per patient, this reinforces the data published recently on the Journal of Cardiovascular Surgery1 and positions the RELAY brand with the lowest number of devices per patient (see figure 1).

By pathology (see figure 2) the RELAY brand has been used mainly for treating Atherosclerotic Aneurysms (47%) followed by Aortic Dissections (27%), PAU (4%), Device Repair (2%) and Other conditions (20%). By gender 81% of the patients treated were male and 19% female.

By proximal landing zone (see figure 3) the RELAY brand has been implanted in 2% of the cases in ZO, 6% in Z1, 23% in Z2, 41% in Z3 and 28% in Z4.

About RELAY and RELAY NBS Thoracic Stent Grafts

Thoracic Stent Grafts specifically designed for the thoracic aorta.
RELAY and RELAY NBS are stent grafts specifically designed for the thoracic aorta and are indicated in the treatment of main thoracic aortic pathologies such as aneurysms, dissections, penetrating ulcers, pseudoaneurysms and intramural haematoma, in adult patients.

The key feature of the RELAY and RELAY NBS is the proximal capture of the stent grafts that allows repositioning before deployment for a precise and controlled release (See picture 2) 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. Two stage Advancement: An integrated 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 22mm to 46mm (2mm step) and tapered grafts are available in diameters ranging from 28mm to 46mm (2mm step), decreasing incrementally by 4mm in the distal portion of the graft.

The RELAY and RELAY NBS Thoracic Stent Graft is available in 4 lengths:

100mm
150mm
200mm
250mm

The RELAY and RELAY NBS Thoracic Stent Grafts are available in many major markets throughout the world. The RELAY Thoracic Stent Graft is an investigational device not available for sale in the United States. In an effort to expand into the thoracic aortic aneurysm repair market, Bolton Medical is conducting its Phase II Clinical trial in the US.

About Bolton Medical

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.

REFERENCES
1. V. Riambau on behalf of RESTORE collaborators. “European experience with Relay™: a new stent graft and delivery system for thoracic and arch lesions”. Journal of Cardiovascular Surgery. J CARDIOVASC SURG 2008;49:407-15

2. Greenberg RK, O’Neill S, Walker E, Haddad F, Lyden SP, Svensson LG et al. Endovascular repair of thoracic aortic lesions with the Zenith TX1 and TX2 thoracic grafts: intermediate-term results. J Vasc Surg 2005;4:589-96.

3. Makaroun MS, Dillavou ED, Kee ST, Sicard G, Chaikof E, Bavaria J et al. Endovascular treatment of thoracic aortic aneurysms: results of the phase II multicenter trial of the GORE TAG thoracic endoprosthesis. J Vasc Surg 2005;41:1-9.

4. Thompson M, Ivaz S, Cheshire N, Fattori R, Rousseau H, Heijmen R et al. Early Results of Endovascular Treatment of the Thoracic Aorta Using the Valiant Endograft. Cardiovasc Intervent Radiol 2007;30:1130-8.