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Cardiovascular Studies 

AppTec serves as a unique single-source provider for comprehensive medical device custom implant studies and materials testing.  Testing services are offered through AppTec's associated facility, Integra Medical Research and Evaluation, located in Minneapolis, Minnesota.   

THE INTEGRA FACILITY

Integra is registered with the USDA and operates in accordance with the Guide for the Care and Use of Laboratory Animals.  The facility has the capacity to house multiple species for implant studies, with modern, fully functional surgical suites and accompanying training suite. 

Supporting equipment includes complete routine surgery equipment plus state-of-the-art fluoroscopy/angiography; echocardiography; Cryocor thermal ablation system; video imaging, recording and links to conference rooms; and a full engineering lab for customer use.  

Staff scientists have over 30 years of cardiovascular device experience including stents, CRM, vascular, grafts and interventional devices. 

Program Features

     ·    Experience with all standard animal models, including rabbit, dog, sheep, goat, pig

     ·    Experienced study director, research surgeon and QA auditor on site, plus physician access

     ·    In-house chemistry, histology interpretation and clinical pathology evaluation

     ·    Model development and evaluation

     ·    Device and pharmaceutical performance and evaluation

     ·    GLP, non-GLP and R&D device design and material testing

     ·    Protocol development and reporting

     ·    FDA / Regulatory guidance

     ·    Data management 

Implant Study Experience

     ·    Cardiac device – permanent/acute (pacing & defibrillator leads, balloons, stents, atherectomy

         & CRM devices)

     ·    Cardiovascular access   

     ·    Peripheral vascular access

     ·    Site-specific organ access

     ·    Electrophysiology

     ·    Interventional procedures     

     ·    Fabric and vascular grafts

     ·    Hemodynamics   

     ·    Heart failure 

     ·    Sensors and implantable monitors 

     ·    Right- and left-side catheterization     

Project  Progression 

     1.    Client contacts Account Manager and consults with AppTec Study Director

     2.    Study design and protocol are developed by AppTec Study Director

     3.    Study is performed at Integra

     4.    QA conducted by AppTec

     5.    Final report prepared and delivered by AppTec to client  

In addition to cardiovascular studies, AppTec offers other custom implant studies, plus complete biocompatibility/safety testing and toxicology studies.