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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
---|---|---|---|---|---|
Lombard Med.Tec | LSE:LMT | London | Ordinary Share | GB00B7FT8W85 | ORD 20P |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 188.50 | 0.00 | 01:00:00 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
---|---|---|---|---|---|
0 | 0 | N/A | 0 |
RNS Number:5668Y Lombard Medical Technologies PLC 17 February 2006 Lombard Medical receives full IDE approval for its US clinical trial of its Aorfix(TM) stent graft London, UK, 17 February 2006 - Lombard Medical Technologies PLC (AIM: LMT) reports today that it has received Investigational Device Exemption (IDE) approval for its US clinical trial of its Aorfix(TM) endovascular stent graft, used in the treatment of abdominal aortic aneurysms (AAAs). The first part of the trial, which begins this quarter, will ultimately be conducted in up to 20 centres and will involve over 250 patients with AAAs and with neck angulations of 60degrees or less being treated with Aorfix(TM). These will be compared with a control group of 110 patients unsuitable for endovascular graft therapy, who will receive conventional open surgery. Recruitment is expected to take approximately 12 to 15 months and patients are followed up for a year which includes CT imaging to check for graft integrity and endoleaks. Lombard will receive revenues for the clinical trials in the US and once recruitment of the US trial has been completed, the FDA will permit the use of Aorfix, pre-approval, in the indications covered by the IDE in those centres that participated in the trial. The Company is pleased to have Dr Ron Fairman of the University of Pennsylvania as Principal Investigator for the study. Dr Fairman is a leader in this field and was the Principal Investigator for a Medtronic thoracic aortic aneurysm stent study. For the second part of the trial, a supplemental IDE will also be filed with the FDA part-way through the trial for approval of a third arm to be added to the study to include a further 110 patients with a neck angulation of greater than 60degrees. There is currently no endovascular stent graft approved for use in patients with such a high neck angulation in the USA. Alistair Taylor, Executive Chairman of Lombard, commented: "We are extremely happy to have received the IDE approval, and it is a significant step for Lombard towards commercialisation of its Aorfix(TM) stent graft in the important US market. "There is a large opportunity in the AAA market for a second generation stent graft, and we believe that Aorfix(TM) is the only one that addresses the limitations of existing devices." Enquiries: Lombard Medical Technologies PLC Tel: 01235 750 800 Alistair Taylor, Executive Chairman Brian Howlett, Chief Executive Officer Financial Dynamics Tel: 020 7831 3113 David Yates / John Gilbert Notes to editors Lombard Medical Technologies is a medical devices company developing stent grafts and other medical products for use in the treatment of vascular disease. The Company's lead product, Aorfix(TM), is a stent graft for the treatment of aortic aneurysms, a balloon-like enlargement of the aorta which, if untreated, may rupture and cause death. Abdominal and thoracic aortic aneurysms are the 13th largest cause of death in the US and the market is estimated to be worth approximately US$2 billion by 2010. Aorfix(TM) is currently being commercialised in the EU, with US clinical trials expected to commence during 2006. The Company has a strategic collaboration with one of the world's leading medical devices companies, Boston Scientific. Lombard Medical has recently successfully completed its initial public offering on AIM and was admitted to listing in December 2005, raising #23.9 million, net of expenses. The Company, based in Oxfordshire & Yorkshire, currently employs 50 people. Further background on the Company can be found at www.lombardmedical.com. This information is provided by RNS The company news service from the London Stock Exchange END MSCAKOKNABKKKBD
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