The world leader in preclinical, interventional and surgical research

Performing human cadaver studies since 2006, NAMSA 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.

Training
The FDA’s expectations 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 devices. It is essential that they be familiar 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 

• Dual Source Computed Tomography (Siemens Somatom® Definition Flash)
• Fluoroscopy (Siemens AXIOM Artis Zee™ Digital Cath Labs, Siemens Avantic™ and Cios mobile c-arms)
• Intracardiac (ICE) and Duplex Ultrasound (Siemens Cypress and Sequoia™)
• Intravascular Ultrasound (IVUS) (Boston Scientific POLARIS™)
• Optical Coherence Tomography (OCT) (Abbot Ilumien Optis)
• Stryker & Olympus Endoscopy Towers

Lab Space

• Two (2) fully-equipped operating suites
• Five (5) hospital-grade digital cath labs
  
• Observation rooms
  
• Two-way communications
  
• Video cameras
  
• Quadview 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

NAMSA is proud to offer interventional and surgical study capabilities in a range of locations across the globe. Working in our state-of-the-art laboratories, NAMSA’s highly-trained experts utilize a broad range of trusted In Vivo models and analysis tools, including five (5) Siemens Cath Labs and a 128-slice CT Scanner, among other advanced technologies, to deliver study results in an accelerated, cost-efficient manner.

Combining decades of experience in therapy delivery systems and implantable medical device research, NAMSA has the distinction of serving as the industry’s premier destination for preclinical interventional research. Our Surgeons/Interventionalists are Doctors of Veterinary Medicine or Academy of Surgical Research certified and have trained with some of the most prominent doctors and researchers in the field.

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 of NAMSA’s surgical suites are maintained to hospital standards. Every suite features temperature and humidity control, with HEPA filtration 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 Sponsors with the most reliable, accurate outcomes in industry.

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

• Cadaveric Non-Clinical Testing
• Cardiac Surgery
• Coronary and Peripheral
• Dental
• Dermal Wound Healing
• Drug Coated Balloons
• Electrophysiology
• Embolization Devices
• Endoscopy
• Gastrointestinal and Urogenital
• Transcatheter and Surgical Heart Valves
• Neuromodulation
• Orthopedic and Bone Healing
• Physician Training
• Pulmonary Therapies
• Specialty Pathology Services
• Stents/Graft
• Tissue Engineering
• Thrombogenicity Testing

Non-GLP studies at an early stage in the medical device development process can minimize the risk of failure during preclinical studies and help Sponsors decide next steps in their 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 this a cost-effective option for Sponsors. 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.

NAMSA offers an array of services for drug discovery programs including efficacy studies, pharmacokinetic (PK) assessments, as well as discovery and GLP toxicology services. We are pleased to offer these services in both rodent and various models, while combining our bioanalytical and histopathology capabilities to centralize your research in our state-of-the-art facilities.

With a focus on pain pharmacology, NAMSA brings years of expertise in behavioral pharmacology to bear on to your projects, helping you prioritize leads and select development candidates. At NAMSA, we understand the importance of delivering quality data as rapidly as possible. Our turnaround times are unmatched and our rigorous approach to positive controls ensures that you will finish with quality data on which to base your crucial go/no-go decisions.

We also understand that the development of novel therapeutics requires the development and validation of novel models and assessment methodologies. When you have chosen your development candidates, let us continue to help with your program needs through our Toxicology Services. From dose-ranging on through acute and chronic studies, and from mice to canines, NAMSA can assist you establish safety and tolerability profiles of your lead molecules.

Pathology is the gold standard for the evaluation of medical device performance and safety. The NAMSA pathology lab is designed for high volume to meet and exceed all of your tissue and device collection requirements. We operate a fully equipped, 5,000 square foot histopathology and SEM laboratory in our main facility.

The NAMSA pathology lab is operated by Board Certified Histotechnicians and has both Board Certified Veterinary Pathologists and MD, PhD Pathologists who oversee gross necropsies, interpret histopathology slides and write reports evaluating the safety of products. The lab also has advanced equipment for the precise sectioning of all medical devices, using paraffin, plastic thin microtomy, plastic EXAKT ground sectioning, and SEM 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)
  
• Histomorphometry
• Scanning Electron Microscope
  
• Stereomicroscopy
  

Cardiovascular

• Abdominal Aortic Aneurysm (AAA)

• Aortic Annuloplasty Balloons

• Atherectomy
• 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)

• Embolic Beads
• Embolic Protection
• Endovascular Grafts

• Guide Catheters

• Guide Wires

• Introducer Sheaths
• Left Atrial Appendage Occlusion
• Myocardial Infarction Models

• Patent Ductus Arteriosus Closure

• Peripheral Bare Metal Stents (BMS)

• Peripheral Drug Eluting Stents and Scaffolds (DES)
• Perivalvular Leak Occlusion
• POBA Balloons
• Renal Denervation
• Septal Defect Closure (ASD, PFO, PMVSD)
• Telemetry
• Thrombectomy
• Transcatheter Valve Replacement (TAVI, TAVR)
• Transseptal Catheters
• Vascular Closure
• Vascular Stimulation

Electrophysiology

• Cardiac Ablation
• Cardiac Leads
• Cardiac Rhythm Management
• EP Recording and Mapping
• Pulmonary Vein Ablation

Gastrointestinal

• Biliary Catheter

• Obesity Devices

Neuromodulation

• Carotid Sinus Stimulation

• Epidural leads

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