A Medical Device Daily
Lombard Medical Technologies (Oxfordshire and Yorkshire, UK) has received conditional approval from the FDA for its supplemental Investigational Device Exemption (IDE) for its pivotal U.S. clinical trial of the Aorfix endovascular stent graft in the treatment of abdominal aortic aneurysms (AAAs).
The company originally envisioned the trial as having two endovascular arms, one for aneurysms with neck angulations of up to 60 degrees (low- or moderate-angle cases) and one for aneurysms with neck angulations of between 60 degrees and 90 degrees (high-angle cases), as well as an open surgery control arm. But the FDA has provisionally accepted arguments in the supplemental IDE submission to have a single endovascular arm in which each center could recruit patients with any neck angle up to 90 degrees following an initial recruitment of five low/moderate angle cases.
Lombard said this change in trial design allows a reduction of the total number of endovascular cases to be performed in the trial from 385 to 210, which will shorten the time required to recruit patients into the trial.
It said that since centers cannot enroll high-angle cases (for which there is no licensed endovascular treatment option) until they have completed five low- or moderate-angle cases, there now is an incentive for them to recruit low- or moderate-angle cases quickly, which should expedite the overall trial recruitment process.
The supplemental IDE also allows Lombard Medical to use the improved version of Aorfix launched in Europe in April in the trials. The company said that product is “much preferred” by physicians due to its greater flexibility, longer shelf life and increased visibility under X-ray.
Full approval of the supplemental IDE is expected in 1Q07 following the submission of further information to the FDA.
Lombard Medical expects to continue to sell Aorfix to trial sites after recruitment is completed under an access program that will require monitoring of patients similar to that performed in the clinical trial.
About 1 in 20 people in the UK over the age of 65 develop AAA and the condition is about six-fold more common in men than in women. In total, ruptured AAAs account for about 2% of all male deaths in England and Wales, equating to 6,000 men a year who die from this complication. The condition also is responsible for 0.45% of deaths in UK women over 65 years of age.
Alistair Taylor, executive chairman of Lombard Medical, said:“As a result of the changes outlined in the conditional IDE patients will benefit from earlier access, albeit in a trial, to a device that can be used in high angle cases for which there is currently no approved endovascular treatment option in the U.S. We believe that this, along with access to our improved device, will have a significant impact on recruitment rates resulting in Aorfix entering the important U.S. market earlier than previously anticipated.”
Lombard Medical, which has a U. S. office in the Boston area, is a specialist cardiovascular device and polymer coatings company developing stent grafts and other products for use in the treatment of vascular disease. It is the only European manufacturer of these devices.
Its latest project is to develop a coated stent that would encourage local self-repair of blood vessels. This involves attaching stem cell-derived endovascular cells to Lombard’s programmable polymer coating on the stent surface, which will allow the human body to promote controlled vascular repair and heal the damaged coronary artery vessel wall itself.
CE mark for Respiratory Viral Panel
Tm Bioscience (Toronto) has received the CE mark for its ID-Tag Respiratory Viral Panel (RVP) and the panel now can be marketed for diagnostic purposes in Europe and other countries where the CE mark is recognized.
The ID-Tag RVP is a test that simultaneously detects up to 20 distinct viral sequences and subtypes that represent more than 95% of all circulating respiratory viruses, the company said.
It said viruses targeted by the panel are important for patient management and include respiratory syncytial virus A and B, influenza A and influenza B, and viruses important for public health and pandemic surveillance, such as SARS and influenza A H5, the subtype associated with avian influenza.
Greg Hines, president and CEO of Tm Bioscience, said the CE mark approval is an important step in the company’s strategy in making the ID-Tag RVP product a worldwide standard for use in public health programs and for use in patient and resource management in clinical environments.
“ID-Tag RVP not only provides clinicians with information on what virus may be causing a respiratory tract infection, but it allows them to rule out what viruses are not causing an infection,” said Donald Low, MD, microbiologist-in-chief, in the department of microbiology at Mount Sinai Hospital in Toronto. “I expect that this technology will be embraced for diagnosing patients with febrile illness day-to-day, as well as on a more global scale in trying to recognize and prevent the emergence of new viral disease.”
Tm Bioscience has signed distribution agreements for ID-Tag RVP in the Netherlands, Scandinavia and Turkey and said it anticipates securing additional distribution agreements for the product.
License given for diagnostic
Innate Pharma (Marseille, France) has signed a license agreement with U.S.-based diagnostics company Clinical Data (Newton, Massachusetts), granting it exclusive rights for the development of a predictive pharmacogenomic test for responsiveness to a treatment by cytotoxic monoclonal antibodies such as rituximab.
The test will be based on the determination of variants of the gene coding for the Fc-gamma-IIIA receptor, for which Innate Pharma owns exclusive intellectual property rights.
Terms of the deal were not disclosed, but Innate Pharma CEO Herv Brailly indicated that the company did not “expect significant financial repercussions in the short term.” He pointed out that, while the “individualization of immunotherapy treatments with the help of predictive markers is at the heart of Innate’s development strategy, we still need to rely on the expertise of a specialist in pharmacogenomic tests for the implementation of this type of predictive test.”
In that regard, Clinical Data, a worldwide supplier of molecular and pharmacogenomics services and genetic tests, was not only a “reference player in this sector,” but also an “industrial partner capable of developing and commercializing this type of test in optimal conditions, especially in the U.S.,” Brailly added.