FDA Acceptance for Aorfix™ as a Modular PMA and Successful Charing Cross Symposium
London, UK, 16 April 2008
Lombard Medical Technologies PLC (“Lombard Medical” or “the Company”), the specialist medical device company, today announces that it has received FDA agreement for Aorfix™ to be filed as a modular PMA with the initial approval of the Modular Shell. Separately, the Company presented at the 30th International Charing Cross Symposium (12-15th April) during which Aorfix™ received considerable interest from clinicians.
Lombard Medical has received agreement to pursue the Aorfix™ PMA as a modular review. This enables preclinical testing sections of the submission to be made, reviewed and accepted ahead of submission of the clinical data potentially leading to a smoother FDA approval process.The Company will submit the first module of the PMA submission containing preclinical and shelf-life data on Aorfix™ in the next couple of months.
The FDA has also approved an alternative training program for those clinicians new to Aorfix™. Following participation in this program clinicians may implant Aorfix™ in those patients with high-angle-neck aneurysms (60° to 90°) for which there is no approved stent graft without first having to implant Aorfix™ in patients with less tortuous anatomy. Lombard Medical believes that this concession will remove an obstacle to trial recruitment that arises from some patients’ reluctance to participate in a trial when there is a licensed alternative for the treatment of their aneurysm.
During the 30th International Charing Cross Symposium several world-leading clinicians presented in satellite symposia on their experience with Aorfix™. Additional data was presented from the Retrospective Aorfix™ Data Retrieval (“RADAR”) registry. The RADAR registry includes 524 datasets from 366 of the 410+ cases supplied to date. Data for those patients for which sequential follow-up data was available continued to compare favourably with NICE Guidance:
NICE Guidance | Aorfix™ | |
| 30-day mortality (of those fit for open surgery) | 2% | 1.3% |
| Stent migration at 12 months | 1% | < 1% |
| Wire fracture at 12 months | 3% | < 1% |
| Aneurysm rupture at 36 months | 0.9% | 0% |
| Endoleaks at 12 months | 19% (mainly type II) | 5.3% (3.5% type II) |
Dr John Hardman and Dr John Rose presented their early experience of Aorfix™ at Royal United Hospital, Bath and Freeman Hospital, Newcastle upon Tyne respectively. In a total of 25 cases treated with Aorfix™, many of which had difficult anatomy, there were no device related complications. Following up in 22 of these patients, for a median nine months, there were no instances of endoleak or migration and in all cases the graft remained patent and the aneurysm sac either shrunk or remained stable. Dr John Hardman supported wider use of Aorfix™ commenting: “We built our confidence in complicated high-angle cases and are now starting to use Aorfix™ in routine cases.”
Dr Petr Varejka, Prague uses Aorfix™ as his primary AAA stent graft and presented the reasons for his selection of Aorfix™ based on his department’s experience from 27 cases .Dr Teßarek from Munster, Germany also presented on his early experience using Aorfix™ in patients with difficult anatomy.
Updates on the ARBITER II trial (14 patients now recruited) to widen CE Mark approval to include patients with aneurysm neck angles of up to 90° and the pivotal US PYTHAGORUS trial (40 patients now recruited) were also given by Dr William Loan, Belfast City Hospital and Dr Mark Fillinger, Dartmouth Hitchcock Medical Centre, Lebanon, USA respectively.
Brian Howlett, Chief Executive of LMT, commented:
“We are very pleased to receive FDA approval for the alternate training and the acceptance of the Modular Shell in line with our goal of gaining FDA approval for Aorfix™ in mid 2010. Furthermore, the level of interest shown in Aorfix™ at Charing Cross has been very promising and bodes well for future sales of the product.”
Enquiries:
Lombard Medical Technologies PLC Tel: +44 (0) 1235 750 800
Simon Neathercoat, Non-executive Chairman
Brian Howlett, Chief Executive Officer
Tim Hall, Finance Director
Financial Dynamics Tel: +44 (0) 20 7831 3113
David Yates / Susan Quigley
Nomura Code Securities Limited Tel: +44 (0) 20 7776 1200
Juliet Thompson / Richard Potts
Notes to editors
About Lombard Medical
Lombard Medical Technologies PLC is a medical devices group developing stent grafts and other medical products for use in the treatment of vascular disease. The Company’s lead product, Aorfix™, is an endovascular stent graft for the treatment of abdominal aortic aneurysms (AAAs), a balloon-like enlargement of the aorta which, if untreated, may rupture and cause death. Approximately 1.7 million people have AAAs in the US where it is the 13th largest cause of death. The market for endovascular stent grafts for the treatment of AAA is currently worth over $600 million and is expected to grow to around a $1 billion by 2010. Aorfix™ is currently being commercialised in the EU, with a pivotal clinical trial ongoing in the USA.
The Company’s Polymer Coatings Division has developed a novel hydrophilic surface treatment to reduce friction on catheters called GlideMax™, which is available for licensing, and is using its polymer coating technology in a number of research collaborations developing novel products for the $5 billion drug-eluting stent market.
The Company headquartered in Oxfordshire, with operations in Yorkshire, Ayrshire and Boston, USA employs over 100 people.
Further background on the Company can be found at www.lombardmedical.com.