Safety and Efficacy Models from a Dedicated Medical Device CRO
Charles River’s two state-of-the-art facilities in North America fully support your cardiovascular, orthopedic, and other preclinical medical device testing programs. Our comprehensive portfolio of services includes imaging modalities and diverse histological endpoints that are quantitatively assessed using manual and software-guided automated histomorphometry. Our staff features dedicated veterinary pathologists who can perform a full histopathological analysis and create resulting quantitative reports.
Cardiovascular Models for Medical Devices
Accelerate your development of cardiovascular therapies and medical devices with specialized models from Charles River.
Trust the expert guidance of our veterinary cardiologist and a team of study directors and veterinary pathologists seasoned in the conduct of sophisticated cardiovascular studies.
Coronary and peripheral studies
Charles River’s Michigan and Quebec sites feature purpose-built surgical and interventional suites to support your preclinical research and medical device testing. Our facilities include four catheterization labs staffed by highly trained professionals, fluoroscopy (digital angiography), intravascular ultrasound (IVUS), optical coherence tomography (OCT), fluoroscopy, echocardiography, image analysis software (for quantitative artery analysis), digital radiography, micro-computed tomography and clinical CT, and magnetic resonance imaging (MRI).
Our scientists routinely perform both coronary and peripheral interventions with a wide variety of devices like drug eluting stent (DES), drug-coated balloons (DCB), bioresorbable scaffolds, venous endovascular devices, diagnostic probes, and more.
Coronary and peripheral studies publications:
Structural and cardiac research
Structural cardiac disease is a rapidly advancing area of medical device development. Using our interventional suites, we can conduct implantation studies on several types of sophisticated cardiac devices such as aortic valve (TAVI) and mitral valve (TMVI) replacements (with transapical or transseptal approaches), tricuspid valve, and closure devices (LAA, PFO).
Charles River continues to invest in advanced instrumentation and modalities to best support the testing of tomorrow’s medical devices. Current on-site technologies include magnetic resonance imaging (MRI) (Siemens 1.5 tesla Magnetom Sonata™), a hybrid surgical room with computer tomography (CT) scanner (Somatom Sensation 16, Siemens) and intracardiac echography (Siemens Acuson) to achieve appropriate sizing pre-implantation, monitor delivery, and evaluate migration and device performance.
Structural and cardiac research posters:
Using electrophysiology (EP) study equipment like EP-Tracer, Cardiotek, and a Biosense Webster Stockert system, Charles River performs EP studies in a variety of large animal models. We can conduct ablation, intracardiac electrical pathway, pacemaker, cardiac defibrillator and arrhythmia, and neurostimulation studies.
Ischemia reperfusion model
Charles River routinely works with challenging myocardial infarction models. In the past 3 years alone, we have conducted more than 16 GLP and/or non-GLP studies in over 500 animals to evaluate diverse treatment modalities, including cell therapies, RNA-based treatments, and local drug delivery. Our surgeons and interventionalists are skilled in both surgical and endovascular approaches for medical device testing and can evaluate LVEF, LVEDV, LVESV; wall motion and wall thickening (both regional and global); infarct size; infarct percentage; area at risk, and edema.
Cardiovascular Models for Medical Devices Product Sheet
Need support for your cardiovascular medical device testing program?
Orthopedic Models for Medical Devices
Charles River provides evaluation services for orthopedic medical devices and biologics from the proof-of-concept to regulatory testing under GLP. State-of-the-art imaging modalities include in life computer tomography imaging (CT-scan), magnetic resonance imaging (MRI), as well as terminal digital and high-definition radiography (Faxitron™), and micro-computed tomography (Micro-CT). Following routine and non-decalcified histology with microgrinding, diverse histological endpoints are quantitatively assessed using manual and software-guided automated histomorphometry.
A full histopathological analysis and quantitative report is provided by experienced veterinary pathologists. In addition, biomechanical testing can be performed in parallel on designated explants and healing sites.
Bone Fracture/Defect Repair Models
Our bone repair models encompass the safety and efficacy evaluation of bone graft substitutes and orthobiologics using long-bone osteotomy and ostectomy (e.g., critical-size segmental defects) press-fitted insertion and gap models. Typical end-points include bone remodelling and bridging, bone-implant contact (BIC), osseointegration and bone ingrowth characterization and quantification.
Bone fracture and defect repair model publications:
Spinal Fusion and Non-Fusion Spinal Models
We offer a range of spinal fusion and non-fusion models, including intervertebral fusion cages, posterolateral lumbar intertransverse spinal fusion (PLF), disc arthroplasty, and nucleus pulposus replacement.
Spinal fusion and non-fusion model posters:
- Novel accelerated neutral atom beam processing as a PEEK surface treatment: a four-month preliminary study using an ovine lumbar intervertebral spinal fusion model
- Evaluation of bone substitutes using a rabbit posterolateral lumbar intertransverse process spinal fusion (PLF) model: a subchronic pilot study
Joint/Cartilage and Soft Tissue Repair Models
Our musculoskeletal expertise covers a wide range of joint and cartilage models, including knee articular cartilage repair, osteochondral defect repair, microfracture defects, osteoarthritis (OA) models (e.g. via anterior cruciate ligament transection or other instability models), ACL reconstruction and fixation models, meniscal reconstruction, as well as rotator cuff repair models.
Joint/Cartilage model publication:
Osteoinduction and Ectopic Bone Models
We offer highly-specialized osteoinduction evaluations, including ectopic bone formation and the muscular pouch model.
Infection and Osteomyelitis Models
Evaluation of the anti-infective properties of a wide variety of drug coated/loaded orthopedic devices utilizing infectious agent challenge models, including BSL-2 agents.
Dental and Craniomaxillofacial Models
Our range of dental and craniomaxillofacial (CMF) models include cranioplasty, parietal bone and mandibular defects, maxillofacial fracture fixation, alveolar ridge augmentation, guided bone regeneration (GBR), osteonecrosis and dental implantation/extraction models.
Craniomaxillofacial device posters and publications:
- Safety and efficacy of a novel, gradually anodized dental implant surface: A study in Yucatan mini pigs.
- Open-porous scaffolds made of short magnesium fibers as bone defect fillers.
- Fracture healing and bone remodeling with human standard-sized magnesium versus polylactide-co-glycolide (PLGA) plate and screw systems using a mini-swine craniomaxillofacial osteotomy fixation model
Orthopedic Models for Medical Devices Product Sheet
Need support for your orthopedic medical device testing program?
Additional Medical Device Testing Models
- ENT: sinus implants drug delivery | bioresorbable stent
- Ocular: enucleation, evisceration | orbital implants
- subcutaneous | dermal filler
- wound healing | hydrogel and wound dressing
- CNS: shunts
- colon stents
- intestinal clips
- Regenerative medicine: Charles River offers a variety of animal models for in vivo evaluation of growth factor therapy, tissue engineering, and cell therapy.
Frequently Asked Questions (FAQs) for Preclinical Medical Device Testing:
What is a medical device?
A medical device is any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or related article intended by the manufacturer to be used in human beings, alone or in combination, for one or more of the specific purpose(s): diagnosis, prevention, monitoring, treatment or alleviation of disease or an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, or control of conception.
How can a medical device CRO improve my preclinical medical device study plan?
Every device is different, and there is no “one size fits all” study plan. Having seen a vast array of medical device types under development, the multidisciplinary team of experts at Charles River uses their deep understanding of efficacy, safety, and regulatory guidelines to develop an appropriate testing strategy to suit the needs of your device. Our unique combination of regulatory expertise with medical devices and comprehensive portfolio of services allows us to create a tailored plan to carry you from the earliest stages of study design to GLP assessments, so you can get you to market faster.
How is Charles River different from other preclinical medical device testing CROs?
Meeting the needs of patients with cardiovascular, orthopedic, dermatology, oncology & immuno-oncology, endocrinology, neuroscience, ophthalmology conditions and more, medical devices serve numerous therapeutic areas. As a global CRO with over 2,000 scientists, Charles River has experts in every field who partner with our dedicated medical devices team to create study designs tailored to your device.