Cardiovascular Facility & Labs
The state-of-the-art surgical facility at the Cardiovascular Innovation Institute (CII) is the only facility in the region devoted to large animal cardiovascular research. Few labs are capable of conducting these types of clinical trials on a large scale with regard to the number of procedures completed and the Good Laboratory Practices (GLP) capabilities that are required prior to FDA approval of devices.
Animal clinical trials are essential, as cardiac devices cannot be downsized and must be tested in an animal model with cardiovascular anatomy and physiology similar to humans. The Animal Care and Use Program at the University of Louisville has been fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) since 1965. The facilities and animal care program are maintained to comply with the USDA Animal Welfare Act and Regulations and the Guide for the Care and Use of Laboratory Animals.
All animal research activities performed in the CII have prior approval by the U of L Institutional Animal Care and Use Committee, which is comprised of researchers, veterinarians and non-scientific and community members. The veterinary staff participates in collaborative research projects with CII investigators. This unique relationship between the CII and U of L Research Resources Facility provides for an ideal environment for the development of cardiovascular devices and procedures that could transform clinical care for cardiac patients.
The surgical facility itself is contiguous with the U of L Research Resources Center and consists of two spacious 650 square foot operating rooms with a large viewing window. A zoom camera resides within the handle of a surgical light in each operating room. Two high-definition, 45-inch flat screen monitors with recording capabilities are housed within the surgical suites, providing the ability to remotely observe surgical procedures in conference and lecture rooms within the CII and Jewish Hospital and St. Mary’s HealthCare System, and provide internet broadcasting capabilities for intercontinental teleconferencing and easy viewing of physiological data during surgical procedures.
Leading-edge anesthesia, surgical and monitoring equipment offers rapid and accurate data acquisition. A fully equipped instrument and equipment processing area with steam and ethylene oxide sterilization adjoins the surgical suites, along with a gas plasma sterilization area. The facility has the most advanced imaging technologies currently available, including a 3-D ultrasound with live color imaging and an open, multi-angular digital fluoroscope for angiography techniques currently only performed in human patients.
Sterile surgical supply rooms, pathology, tissue handling facilities and a full-service veterinary diagnostic laboratory provide additional support necessary for research and clinical trials. This, in addition to the expertise provided by highly qualified professionals from medical, engineering and veterinary disciplines, allows for comprehensive research and data collection capabilities.
The RRF continually seeks to provide unparalleled quality of laboratory animal care, thereby minimizing the potential for animal distress and its negative impact on research data. The CII team strives to complete pre-clinical trials in the most appropriate animal models in an expedient and responsible manner prior to testing in humans. Ultimately, this will have a profound impact on the current treatments and quality of life for human cardiac patients.
In December 2009, The Cardiovascular Innovation Institute completed construction of a “first of its kind” translational research cleanroom. The purpose-built room has a highly controlled sterile filtered airflow designed to minimize dust and contamination potential and aid in complete cleaning of the space from ceiling to floor. The CII cleanroom suite is maintained under the current Good Manufacturing Practice (GMP) regulations of the FDA and provides researchers and clinicians with a facility to produce regulated products for clinical use. The cleanroom suite affords the opportunity to translate both cell and bio-hybrid (cells combined materials) therapies from the research being conducted at the CII into clinical practices.
The completion of the cleanroom suite positions the CII as an elite facility capable of addressing the FDA regulatory requirements for both GLP and GMP initiatives.
Other state-of-the-art technologies include:
- Siemens Skyra 3T MRI
- GE INNOVA Fluoroscopy Suite
- Phillips 3-D Ultrasound
- Vevo 2100 (high frequency ultrasound)
- Volcano Intravascular Ultrasound
- CAD/CAM Micromilling equipment
- COBE 2991 Cell processing system
- BioRad and Rotor-Gene Thermocyclers
- NiKon, Olympus and Zeiss fluorescence/brightfield microscopes
- Olympus FV1000-MPE Confocal/Multi photon microscope
- JEOL Scanning Electron Microscope
- Sonosite 2D Ultrasound
- Moor Laser Doppler Imager (LDPI)
- Cardiopulmonary Bypass Support
- DSI physiological monitoring & data collection
- Telemetry (small and large animal)
- PV Loop Systems (Millar)
- Virtis Lyophilizer
- Leica Microtome
- Flexcell Tissue Culture System
- BioPrinting System (NScrypt)
- Instron Dynamic Testing System
- Roland 4-axis Mill
- Fluorescence Activated Cell Scanner (FACS) BD
- FACSCalibur and BD FACSAria
- Polycom Videoconference System (Portable)