We help medical device manufacturers verify that their products perform according to their intended function. Preclinical studies are used to select prototypes and provide an understanding of device performance in a specific application. Our scientists offer a broad range of in vivo models and analysis tools that will provide data in support of a specific application of a device.
Our veterinary surgeons select study models based on expected biological hazards to assess function and performance. In vivo studies mirror the clinical end use of the device to verify the device will perform with an appropriate host response in a specific application. The same analysis tools are used for the preclinical and clinical study, such as angiography, CT scan, MRI or X-rays, resulting in the most effective testing program. We follow the methods described in the CEN, FDA standards and other applicable guidelines.
TYPES OF STUDIES & CAPABILITIES INCLUDE:CardiovascularCardiovascular studies to assess the blood material interface of a device - Functional models are available for coronary and peripheral vascular stents, inferior vena cava filters, vascular prostheses, heart values and other cardiovascular devices.
- Angiography
- Quantitative assessment of thrombus deposition
- Computerized angiography, radiography, CT scan, MRI
- Resin technology histopathology
- Image analysis
- Atherosclerotic models
- Aneurysm models
- Patency, duration of permeability
- Flow measurements
- Sequential surface sampling
- SEM examination
- Material/blood interface
- Embolism in distal organs
- Histopathology of device in situ
Bone Healing- Osteoformation, bone ingrowth, cortical bone anchorage and bone substitute evaluation
- Osteoinduction models in various sites
Dental- Test methods that reproduce clinical exposure
- Procedures to satisfy ISO, FDA or ADA requirements
- Specific models for dental implants as well as dental material evaluation
Drug Delivery- Drug delivery studies, including transdermal patch studies and pharmacokinetic studies to assess efficiency of drug delivery process, local effects and effects on target organs
- Evaluations under clinical-like conditions
- Blood level evaluations
- Evaluation of local tolerance
- Other studies related to drug use and intended purpose
Gastrologic- Clinic-like treatments or implants
- Shunts
- Liver resection
- Pancreas Pathologies
General Surgery- Numerous functional study models for adominal repair meshes, adhesion prevention products, suture procedures and evaluating new surgical instruments and techniques.
Histopathological evaluation- Microscoptic evaluation to assess material acceptance or rejection, bone formation rate, osteo-integration, bone mineralization, thrombosis degradation kinetic of polymers or inflammatory reaction.
- Exact® Histological System for specialized Tissue-Implant Processing
Neurologic- Spinal fusion
- Reconstruction of intervertebral disc
- Disc replacement
- Dura/vertebrae anti-adhesion
- Hydrocephalic shunt devices
- Bone repair (skull, vertebrae)
- Histopathology of device in situ
Safety studies- Safety studies to assess biological safety can be included in the design of a performance study in certain situations-one study can be conducted to address both safety and performance, reducing overall testing and time-to-market.
Obstetrics/Gynecology- Bladder positioning and repair models
- Antiadhesion product evaluations in various models
Ophthalmolgy- Corneal healing studies to assess superficial and lamellar keratectomy, and other conditions
- Intraoccular lens studies in rabbits
- Vitreal procedures
- Conjectival implants
Orthopedic- Orthop
- Assess joint replacement, ligament and tendon reconstruction
- Spine surgery and bone reconstruction Implantations under clinical conditions
- Anterior crutiate ligament repair
- Ligament/tendon fixation
- Fracture repairs
- Long bone defect repair
- Cortical, trabecular, cranial, maxillofacial defects
- Osteoporosis
- Osteomyelitis treatment
- Orthopedic prosthetic infection
- Articular cartilage repair
- Ligamentoplasty
- Arthroplasty
- Spinal fusion
- Reconstruction of intervertebral disc
- Disc replacement
- Histopathology of device in situ
Tissue Engineering- Treatment or implant with a matrix/scaffold seeded with animal cells similar to the human condition
- Final product implant or treatment to immunosuppressed mice and rats
- Routine implant of matrix/saffold
Urology- Clinical-like implants or treatments
- Evaluate catheter encrustation, coatings or anti-adhesion
- Physical or leakage testing
- Local tolerance tests (implants)
Wound Healing- Full and partial skin thickness wounds
- Multiple non-clinical models
- Special models using diabetic rats, atonic wounds and superficial burns
- Wound treatments with growth factors incorporated
- Sutured and un-sutured surgical wounds
