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NAMSA
Preclinical Research Services

INNOVATIVE SURGICAL INSTRUMENTATION AND CERTIFIED MEDICAL EXPERTS TO FULLY SUPPORT YOUR PRECLINICAL, INTERVENTIONAL AND SURGICAL RESEARCH NEEDS

Innovative surgical instrumentation and certified medical experts to fully support your preclinical, interventional and surgical research needs.

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1100

Annual Preclinical Projects

6

Cath Labs

250

Annual GLP Surgical Research Projects

When it comes to the successful preclinical testing of medical devices, experience matters. NAMSA has the largest depth of therapeutic expertise of any development partner on the planet — backed by over 50 years in business. That equates to unparalleled preclinical laboratory support for Sponsors from all over the world, at our GLP-compliant and AAALAC-accredited facilities in the United States and Europe. 

NAMSA’s preclinical research services allow you to evaluate your product or device for safety and performance. Our GLP-compliant studies follow strict regulatory guidelines and utilize both small and large preclinical models to assess multiple treatment modalities and implantation requirements, including:

  • Cardiovascular/Cardiothoracic/Vascular Studies
  • Dental Studies
  • Dermal Studies
  • Electrophysiology Studies
  • Gastrointestinal Studies
  • Hemostasis Studies
  • Neuromodulation and Neurological Effects Studies
  • Ophthalmology Studies
  • Orthopedics Studies
  • Pulmonary Studies
  • Thrombosis/Thromboresistance Studies
  • Urogenital Studies
  • Wound Healing Studies
  • and many others

Our highly sought-after global teams are experts at designing and executing studies to bridge preclinical safety endpoints to proposed clinical endpoints, allowing clinical labs to standardize measurements and obtain expert interpretations of results. We can also support early feasibility testing with non-GLP studies, intended to provide iteration and proof-of-concept prior to investment in GLP programs.

NAMSA keeps cutting-edge imaging technology at the heart of all preclinical research services, including:

  • Imaging for visualizing implants/tissues/device performance 
  • Diagnosing defects or disease
  • Documenting research outcomes

In addition, NAMSA’s surgical staff — including Doctors of Veterinary Medicine, Academy of Surgical Research-certified Surgeons and Interventionalists, and Board-certified Pathologists— are equipped with the necessary tools to support your entire procedure or to fill procedural role gaps as needed. When you need thorough laboratory research or preclinical testing of medical devices, NAMSA’s team is here to provide the expertise.

 

 

NAMSA Lab Equipment and Facilities

 
Bioskills, Simulation, and Physician-Training Lab

Performing human cadaver studies since 2006, NAMSA Minneapolis is an approved human cadaver lab site authorized to perform device evaluations. We provide whole body cadavers as well as partial cadavers or various tissues. Combining our access to tissues with our equipment and expertise allows us to provide device evaluations at the highest levels. We also provide in vivo tissue for use in wet lab device evaluations.

 

Physician/User Training
Expectations from worldwide regulatory institutions for physician training and human factors testing within the medical device arena are continuing to grow. It’s more important than ever to bring physicians, engineers, and technical staff into the simulation lab to learn and train on medical devices. It is essential that they overcome the learning curve on medical devices as well as procedures with these complex systems as they accurately simulate the feel and rigors of an operating room (OR) or catheterization lab. NAMSA’s facilities can fulfill this need, as well as host or train your internal trainers with expertise from our staff.

Imaging Equipment 

  • Computed Tomography (CT)
    • Dual-Source, 128-slice clinical CT
    • Micro-CT
  • Fluoroscopy
    • Fixed Cath Lab C-Arms
    • Mobile C-Arms
  • Ultrasound
    • Transthoracic Ultrasound (TTE)
    • 3D Intracardiac Ultrasound (ICE)
    • 3D Transesophageal Ultrasound (TEE)
    • Intravascular Ultrasound (IVUS)
  • 3D Optical Coherence Tomography (OCT)
  • Endoscopy Towers
  • X-Ray Imaging, including Faxitron

Lab Space

  • Fourteen (14) fully-equipped operating rooms
  • Six (6) hospital-grade digital Fixed-Arm Cath Labs
  • Observation rooms
  • Two-way communications
  • Video cameras
  • HD video recording systems
  • Sponsor suite for on-site viewing of procedures
  • Webcasting and virtual viewing capabilities for off-site monitoring, including 2-way communication

Specimen Preparation Techniques

  • Fresh or Fixed Tissue
  • Full or Partial Perfusion
  • Resin and Silicone Casts
Imaging and Data Collection Modalities

NAMSA offers cutting edge equipment and techniques designed for cardiovascular and peripheral vascular research. We have six digital cardiac catheterization labs featuring state-of-the-art Fixed C-arm platforms. We can to accommodate your timelines no matter how large the study design or last minute the request.

We feature dedicated workstations in each Cath Lab for real-time quantitative coronary/vascular angiography (QCA/QVA) analysis and evaluation.

Quantitative angiography may be augmented by additional types of intravascular imaging, including, intravascular ultrasound (IVUS), and intracardiac ultrasound (ICE).

Our preclinical testing and research services include access to a dedicated picture archiving and communication system (PACS) server that’s available for storing and retrieving cases.

  • Computed Tomography (CT)
    • Dual-Source, 128-slice clinical CT
    • Micro-CT
  • Fluoroscopy
    • Fixed Cath Lab C-Arms
    • Mobile C-Arms
  • Ultrasound
    • Transthoracic Ultrasound (TTE)
    • 3D Intracardiac Ultrasound (ICE)
    • 3D Transesophageal Ultrasound (TEE)
    • Intravascular Ultrasound (IVUS)
  • 3D Optical Coherence Tomography (OCT)
  • Endoscopy Towers
  • X-Ray Imaging, including Faxitron

NAMSA also has long-standing partnerships with a network of trusted experts when additional diagnostic imaging and analysis is needed.

Interventional and Surgical Research

NAMSA is proud to offer interventional and surgical research for a variety of medical devices worldwide. Working in state-of-the-art laboratories, our highly-trained experts utilize a broad range of trusted in vivo models and analysis tools, including six (6) Fixed C-Arm Cath Labs, a 128-slice CT Scanner, and more, to deliver accelerated, cost-efficient results.

Combining decades of experience in therapy delivery systems and implantable medical device research, NAMSA serves as the industry’s premier destination for preclinical interventional research.

Although NAMSA’s surgical staff is equipped with all the necessary tools to support your entire procedure, we also provide à la carte services to support your preclinical needs. Interested in having your key opinion leader (KOL) or design team personnel work with your product? No problem. The NAMSA team will fill in the necessary gaps in procedure roles so that your staff can concentrate on their duties during the implant or treatment procedure.

All NAMSA’s surgical suites are maintained to hospital standards. Every suite is equipped for a full aseptic surgical field.

We also understand the criticality of complying with methods and regulations within the European Committee for Standardization (CEN), U.S. Food and Drug Administration (FDA) and other international guidelines to provide reliable, accurate outcomes.

NAMSA has extensive experience in the following interventional models and device product testing:

  • Cardiovascular
    • Abdominal aortic aneurysm (AAA)
    • Aortic annuloplasty balloons
    • Atherectomy
    • Cardiac assist devices (left ventricular assist devices to total artificial heart)
    • Cardiac rhythm devices
    • Cell and gene therapy
    • Chronic total occlusion/total partial occlusion crossing wires (CTO)
    • Coronary bare metal stents (BMS)
    • Coronary drug-eluting stents and scaffolds (DES)
    • Drug-coated balloons (DCB/DEB)
    • ECMO and ECLS
    • Embolic beads
    • Embolic protection
    • Endovascular grafts
    • Guide catheters
    • Guide wires
    • Introducer sheaths
    • Left atrial appendage occlusion
    • Myocardial infarction models
    • Neurovascular stents
    • Patent ductus arteriosus closure
    • Peripheral bare metal stents (BMS)
    • Peripheral drug-eluting stents and scaffolds (DES)
    • Perivalvular leak occlusion
    • POBA balloons
    • Septal defect closure (ASD, PFO, PMVSD)
    • Surgical valve implantation
    • Telemetry
    • Thrombectomy
    • Transcatheter valve replacement (TAVI, TAVR, TMVR)
    • Transseptal catheters
    • Vascular closure
    • Vascular stimulation
    • Venous sinus stents
  • Electrophysiology
    • Cardiac ablation
    • Cardiac leads
    • Cardiac rhythm management
    • EP recording and mapping
    • Pulmonary vein ablation
  • Gastrointestinal
    • Biliary catheter
    • Obesity devices (gastric bypass, gastric bands, balloons,
    • Endoscopy (gastroscope, duodenoscope, colonoscope)
    • Fistulated models
  • General Surgery
    • Laparoscopic stapling devices (lung and GI)
    • Anastomosis stapling devices
    • Dermal fillers
    • Breast implants
    • Laproscopic energy devices
    • Hernia repair
    • Hemostats
    • Dural repair
    • Biopsy devices
    • Robotic surgery
    • Reconstruction meshes
    • Drainage catheters
  • Neuromodulation
    • Deep brain stimulation
    • Spinal cord stimulation
    • Peripheral nerve stimulation
    • Carotid sinus stimulation
    • Renal denervation
    • Epidural leads
  • Ocular
    • Intraocular lenses (IOLs)
    • Aqueous shunts
    • Viscosurgical devices
    • Retinal and intra corneal implantation
    • Lens replacement
    • Topical irritation
    • Corneal wounds
    • Subconjucntival implatation
    • Citrectomy
  • Orthopedic
    • Bone void fillers
    • Spine fusion devices
    • Spinal cage placement
    • Cranioplasty
    • Critical-size bone defects
  • Pulmonary
    • Bare metal stents and scaffolds
    • Drug-eluting stents and scaffolds (DES)
    • Lung biopsy
    • Lung denervation
    • Lung volume reduction
    • Tracheal stent
  • Urogenital
    • Kidney cellular regeneration
    • Prostate ablation
    • Uterine ablation
  • Wound Healing
    • Full thickness wounds
    • Partial thickness wounds
    • Incisional wounds
    • Traumatic wounds
    • Burn models
    • Contaminated wounds
    • Epidermal grafting
Non-GLP Preclinical Surgical Research

Non-GLP studies at an early stage in the development process can minimize the risk of failure during GLP preclinical studies and help Sponsors decide next steps in their research, development and testing processes.

Non-GLP studies receive less regulatory scrutiny and do not have the same archive and report standard requirements as GLP studies, making them a cost-effective option. As a result, non-GLP studies can also be scheduled and carried out more quickly due to shorter testing durations, smaller sample sizes and faster report delivery.

Finally, a non-GLP study can be very useful in providing important insights and data on how a device is performing in vivo—an important step before Sponsors invest in a GLP study. Pricing can be optimized if both non-GLP and GLP studies are completed at NAMSA.

Pathology

Pathology is the gold standard for the evaluation of medical device performance and safety. NAMSA pathology labs are designed for high volume to meet and exceed all of your tissue and device collection requirements. We operate fully equipped histopathology and SEM/TEM laboratories in our facilities to help meet a wide variety of preclinical testing needs.

The NAMSA pathology labs are operated by qualified histotechnicians and have Board Certified pathologists who oversee gross necropsies, interpret histopathology slides and write reports evaluating the safety of products. The labs also have advanced equipment for the precise sectioning of all medical devices, using paraffin, plastic thin microtomy, laser microtome systems, plastic EXAKT ground sectioning, and SEM and TEM techniques.

GROSS PATHOLOGY CAPABILITIES

Post-Mortem Exams

  • Large / Small in vivo models
  • Evans blue staining
  • Ex-vivo perfusion fixation
  • Fluorogram guided tissue harvesting
  • In-situ perfusion fixation
  • Microdissection
  • Pharmacokinetic sampling
  • TTC in-situ and ex-vivo staining

Imaging

  • High-resolution radiography (Faxitron)
  • Micro-CT
  • Histomorphometry
  • Scanning electron microscopy (SEM)
  • Transmission electron microscopy (TEM)
  • Stereomicroscopy
Specific Product Expertise
  • Cardiovascular
    • Abdominal aortic aneurysm (AAA)
    • Aortic annuloplasty balloons
    • Atherectomy
    • Cardiac assist devices (left ventricular assist devices to total artificial heart)
    • Cardiac rhythm devices
    • Cell and gene therapy
    • Chronic total occlusion/total partial occlusion crossing wires (CTO)
    • Coronary bare metal stents (BMS)
    • Coronary drug-eluting stents and scaffolds (DES)
    • Drug coated balloons (DCB/DEB)
    • ECMO and ECLS
    • Embolic beads
    • Embolic protection
    • Endovascular grafts
    • Guide catheters
    • Guide wires
    • Introducer sheaths
    • Left atrial appendage occlusion
    • Myocardial infarction models
    • Neurovascular stents
    • Patent ductus arteriosus closure
    • Peripheral bare metal stents (BMS)
    • Peripheral drug-eluting stents and scaffolds (DES)
    • Perivalvular leak occlusion
    • POBA balloons
    • Septal defect closure (ASD, PFO, PMVSD)
    • Surgical valve implantation
    • Telemetry
    • Thrombectomy
    • Transcatheter valve replacement (TAVI, TAVR, TMVR)
    • Transseptal catheters
    • Vascular closure
    • Vascular stimulation
    • Venous sinus stents
  • Electrophysiology
    • Cardiac ablation
    • Cardiac leads
    • Cardiac rhythm management
    • EP recording and mapping
    • Pulmonary vein ablation
  • Gastrointestinal
    • Biliary catheter
    • Obesity devices (gastric bypass, gastric bands, balloons,
    • Endoscopy (gastroscope, duodenoscope, colonoscope)
  • General Surgery
    • Laparoscopic stapling devices (lung and GI)
    • Anastomosis stapling devices
    • Hernia repair
    • Hemostats
    • Dural repair
    • Biopsy devices
    • Robotic surgery
    • Reconstruction meshes
    • Drainage catheters
  • Neuromodulation
    • Deep brain stimulation
    • Spinal cord stimulation
    • Peripheral nerve stimulation
    • Carotid sinus stimulation
    • Renal denervation
    • Epidural leads
    • Nerve grafts
    • Dural repair devices
  • Ocular
    • Intraocular lenses (IOLs)
    • Aqueous shunts
    • Viscosurgical devices
    • Topical eye drops
    • Contact lenses
    • Glaucoma drainage devices/shunts
    • Corneal wound healing products
  • Orthopedic
    • Bone void fillers
    • Spine fusion devices
    • Cranioplasty
    • Ligament and tendon repair and fixation
    • Cartilage repair
    • Joint supplementation
    • Bone grafts
    • Cements
    • Screws, plates, pins, fixation devices
    • Osteochondral implant
    • Chondrogenic products
    • 3D printed devices
    • Antimicrobial devices
    • Osteo inductive/conductive material and coatings
  • Pulmonary
    • Bare metal stents and scaffolds
    • Drug-eluting stents and scaffolds (DES)
    • Lung biopsy
    • Lung denervation
    • Lung volume reduction
    • Tracheal stent
  • Urogenital
    • Kidney cellular regeneration
    • Prostate ablation
    • Uterine ablation
  • Wound Healing
    • Occlusive dressings
    • Absorbent dressings
    • Antimicrobial dressings
    • Dermal substitute
    • Cream/gel/glues
    • Negative pressure wound therapy
    • Growth factors
    • Nano-coatings
Usability Testing

Human Factors Usability Testing is not just a regulatory requirement. Incorporating the User Experience in each phase of your product development is essential for safety. Unlock the potential of your product with our comprehensive usability testing services. Our expert team specializes in guiding key design and product development decisions, ensuring a seamless user experience and paving the way for commercial success. From MedTech to IVD therapeutic areas, we offer expertise in designing, implementing, and analyzing usability tests that meet global standards. Our extensive experience spans diverse evaluations across various product categories, positioning your innovation for regulatory approval and market dominance.