We help medical device manufacturers test and verify product performance according to intended function. Efficacy studies—part of NAMSA’s preclinical studies—are used to select prototypes and provide an understanding of device performance in a specific application of a medical device. Our scientists, dedicated to offering the best contract research organization (CRO) services, 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 device
  • Functional models for coronary and peripheral vascular stents, inferior vena cava filters, vascular prostheses, heart valves and other cardiovascular devices
  • Ventricular Assist Devices
  • Electrophysiology including Pacing and Defibrillation
  • 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
  • Histomorphometry
  • Cardiac pacing and defibrillation
  • Hemostasis
  • Vascular filtration
  • Hypertension
  • Dialysis
  • Left ventricular assist and artificial heart
  • Vascular graft
  • PICC catheter
  • Thromboembolism

Cadaveric Non-Clinical Testing

  • Anatomical Research and Development
  • Dissection and Instruction of Human Anatomy
  • Comparative Anatomy
  • Anatomical Casting
  • Diverse anatomical models for all medical disciplines
  • Safe serologically pre-screened human specimens
  • Medical records screening for disease conditions of interest
  • Advanced specimen processing
  • Extensive surgical and interventional capabilities
  • Advanced imaging and video services
  • Large training and surgical facility
  • Domestic and international travel capabilities
  • Pathology Services

Dental

  • Test methods that reproduce clinical exposure
  • Procedures that satisfy ISO, FDA, or ADA requirements
  • Specific models for dental implants as well as dental material evaluation
  • Histopathology of device in situ

Drug Delivery

  • Drug delivery studies
  • Evaluations under clinical-like conditions
  • Blood level evaluations
  • Evaluation of local tolerance
  • Other studies related to drug use and intended purpose
  • Intraduodenal drug administration
  • Combination devices

Gastroenterology

  • Clinic-like treatments or implants
  • Shunts
  • Stomas
  • Liver resection
  • Pancreas pathologies
  • Intragastric methods
  • Histopathology of device in situ

SPECIALIZED PATHOLOGY SERVICES

  • Exakt® Histological System for specialized tissue-hard implant processing
  • Quantitative Pathology
  • Biomarkers and immunohistochemistry
  • Ultrastructural Pathology (SEM, TEM)
  • Ostomy procedures
  • Anastomosis studies
  • Gastric reduction
  • Board Certified Veterinary Pathologists

Neurosurgery and Spine Surgery

  • Spinal fusion
  • Reconstruction of intervertebral disc
  • Disc replacement
  • Dura/vertebrae anti-adhesion
  • Hydrocephalic shunt devices
  • Bone repair
  • Histopathology of device in situ
  • Neurostimulation including hypoglossal, vagal, splanchnic, vertebral,baro receptor, renal, sciatic,vertebral and spinal chord.
  • Neurostimulation and Electrophysiology
  • Pain relief
  • Ambulation

Ophthalmology

  • Corneal healing studies
  • Intraocular lens studies (ISO standard)
  • Vitreal procedures and replacement materials
  • Conjunctival implants
  • Aqueous shunts
  • Ocular pathology consultation
  • Histopathology of device in situ
  • Glaucoma implants

Orthopedic and Bone Healing

  • Assessment of joint replacement, and ligament and tendon reconstruction
  • Spine surgery and bone reconstruction implantations
  • Anterior crutiate ligament repair
  • Ligament and tendon fixation
  • Fracture repairs
  • Long-bone defect repair
  • Cortical, trabecular, cranial, and 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
  • Evaluation of bone formation rate and osteointegration
  • Evaluation of bone mineralization, thrombosis and degradation
  • Osteoformation, bone ingrowth, cortical bone anchorage and bone substitute evaluation
  • Osteoinduction models

Physician Training

  • Video equipment
  • Sizable classroom space for dry labs
  • Internal and external data links
  • Video presentations
  • Wet lab and surgical suite

Tissue Engineering

  • Treatment or implant with a matrix or scaffold seeded with test model cells
  • Final product implant or treatment
  • Routine implant of matrix or scaffold
  • Cellular Therapies

UROGENITAL SYSTEM

  • Clinical-like implants or treatments
  • Evaluation of catheter encrustation, coatings, or antiadhesion
  • Physical or leakage testing
  • Local tolerance tests (implants)
  • Bladder positioning and repair models
  • Anti-adhesion product evaluations in various models
  • Vaginal or penile material testing
  • Prostatic ablation

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 unsutured surgical wounds
  • Histopathology of wound healing

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, accelerating time to market.
  • Evaluation of localized tissue response and systemic toxicity of implantable test articles
  • Systemic Toxicity
  • GLP combined Safety, Toxicity and Sight Evaluation

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

Are NAMSA’s services a good fit for your needs? Contact a NAMSA representative +1-866-666-9455 (+1-419-666-9455 if you’re outside the US) or through our site contact form.