Newsletter # 8_November 2009 Non-destructive x-ray testing of medical devices at IMM Recherche Page 1 of 4

Newsletter #8 of IMM Recherche, November 2009

Non-destructive x-ray testing of medical devices

and tissue explants at IMM Recherche

“Imaging is a corner stone of our activity in large animal preclinical research. We recently bought the motorized version of the latest OEC Elite from General Electric Medical System, for superior angiographic imaging. We are also looking into 3D ultrasound for the up-coming year. But ex vivo x-ray imaging of explanted stents and valves requires high precision cabinet x-ray system. We invested in the Faxitron MX-20 Radiography System, used in medical, forensic, scientific and agricultural applications. It provides on-the-spot images in seconds and can export in most formats. Never have we been so well equipped to get non-destructive information into calcification of biologic material and metallic device integrity.”

Dr Nicolas Borenstein, DVM, PhDScientific and technical manager

IMM Recherche

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During safety and efficacy studies led at IMM Recherche, we often have to provide evidence of local tolerance and behaviour of medical devices. This is typically performed through histopathologic studies on explanted tissue. But this approach is indeed destructive and provides very localized albeit extremely insightful information. Non destructive imaging of explanted tissue and medical devices can greatly benefit from the use of x-ray cabinets, such as the MX-20 from Faxitron X-Ray Corporation.

Stents, metal rings, orthopaedic devices of all sorts, bone and tooth can be introduced in the Faxitron cabinet, focussing on tissue as well as on device integrity (metallic stress fracture, unwinding of metal springs, etc.)

Calcification can be greatly visualized in all specimens, but in particular in tissue valves. Calcification assessment is of paramount importance in the validation process of cardiac bioprotheses and Faxitron x-ray assessment delivers the global image we need for this validation. Complementary calcium and phosphorus content can also be assessed by atomic absorption spectroscopy and specific immunohistochemistry techniques we carry out routinely.

Superior image quality

Our MX-20 x-ray cabinet is equipped with a large 12 cm x 12 cm camera (single-chip CMOS detectors). With a 5X additional geometric magnification, it delivers ultra high-contrast and high spatial resolution images in DICOM, bmp or tif format.

Figure 1 : non-calcified bioprosthesis

Figure 2 : os cordis (small bone found inside the heart of ruminants)

Figure 3 : MX-20 by Faxitron Corporation

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Interestingly, the Faxitron cabinet can be used for other medical purposes (forensic or oncologic studies) and non medical purposes such as non destructive testing of printed circuit boards, automotive parts, aerospace components, gems, and agricultural purposes (grain and seed inspection, tree bark to inspect for insect infestation).

The MX-20 (pdf datasheet) completes our panel of high end equipment and processes designed to produce the most relevant and presentable data for medical device validation.

IMM RECHERCHE VIDEOS http://www.imm-recherche.com/movies

Our know-howCardiovascular surgery

Interventional cardiologySurgical research

Complete pathology servicesPhysician training

Good Laboratory PracticeFull undertaking of your project

We have more than 20 years experience in large animal surgical research, interventional

radiology, validated procedures, cutting-edge equipment and state of the art surgical

suites. We have a strong know-how in cardiovascular research but also in,

ophthalmology, thoracic surgery, neuro-surgery, orthopedics, dentistry, urology,

fetal surgery and robotics. In addition IMM Recherche offers a state-of-the-art medical

device pathology service. We follow the methods of Good Laboratory Practice to

assure the highest professional standards. Our team will strive to service your study and help you bring your medical device to

market in a timely and cost effective manner.