We help medical device manufacturers test and verify product performance according to intended function. Efficacy studies are used to select prototypes and provide an understanding of device performance in a specific application of a medical device. 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 medical device.
Types of Studies
Cardiovascular
- Cardiovascular studies to assess the blood material interface of a medical device
- Functional research models are available for coronary and peripheral vascular stents, inferior vena cava filters, vascular prostheses, heart valves 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 and 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 evaluating dental implants and dental material
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
- Intraduodenal drug administration
Gastroenterology
- Clinic-like treatments or implants
- Shunts
- Liver resection
- Pancreas pathologies
- Intragastric methods
Histopathological Evaluation
- Microscopic evaluation to assess material acceptance or rejection, bone formation rate, osteo-integration, bone mineralization, thrombosis degradation kinetic of polymers, or inflammatory reaction
- Exakt® Histological System for specialized tissue-implant processing
Neurosurgery and spine surgery
- Spinal fusion
- Reconstruction of intervertebral disc
- Disc replacement
- Dura/vertebrae anti-adhesion
- Hydrocephalic shunt devices
- Bone repair (skull, vertebrae)
- Histopathology of device in situ
Obstetrics/Gynecology
- Bladder positioning and repair models
- Antiadhesion product evaluations in various models
Ophthalmology
- Corneal healing studies to assess superficial and lamellar keratectomy and other conditions
- Intraocular lens studies (ISO standard)
- Vitreal procedures and replacement materials
- Conjectival implants
- Aqueous shunts
Orthopedic
- Assessment of joint replacement, and ligament and tendon reconstruction
- Spine surgery and bone reconstruction implantations under clinical conditions
- Anterior cruciate 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 or scaffold seeded with test model cells similar to the human condition
- Final product implant or treatment to immunosuppressed test models
- Routine implant of matrix or scaffold
Urology
- Clinical-like implants or treatments
- Evaluation of 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 test models, atonic wounds and superficial burns
- Wound treatments with growth factors incorporated
- Sutured and un-sutured surgical wounds
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.
Reconstructive and General Surgery
- Dermal void fillers
- General void fillers
- Hernia repair
- Hemostatic-devices or material models
- Abdominal repair meshes
- Adhesion prevention products
- Suture procedures
- Evaluation of new surgical instruments and techniques