Device Category Experience
PRECLINICAL STUDY CENTER FOR INNOVATIVE MEDICAL DEVICE
Structural heart disease

Goldenwing Medical has wide experience with cardiac, cardiovascular, and neurovascular devices, managing a variety of projects each year. The technical specialists and scientists in our cardiovascular Contract Research Organization (CRO) excel at developing preclinical testing programs and evaluating functionality of these devices.

Testing these devices in large animal models, such as pigs, sheep, dogs, or rabbits helps researchers understand their behavior in a living system, providing valuable data on safety, efficacy, and potential complications before moving to human trials. This preclinical phase is vital for refining device designs and ensuring optimal performance in clinical settings.

1. Heart Valves
     · Mechanical Heart Valves: Devices like mechanical aortic and mitral valves are tested for durability.
     · Bioprosthetic Valves: Tissue-based valves used for assessing hemodynamics and tissue integration.
     · Transcatheter Heart Valves: Devices for TAVR, such as balloon-expandable or self-expanding valves, tested for delivery and implantation techniques.

2. Septal Occluders
     · Atrial Septal Defect (ASD) Occluders: Devices designed to close ASDs can be evaluated for effectiveness and long-term outcomes.
     · Patent Foramen Ovale (PFO) Closure Devices: Assessed for closure efficacy and prevention of embolic events.

3. Mitral Valve Repair Devices
     · Mitral Clips: Devices such as the MitraClip, used for percutaneous mitral valve repair, tested for placement and function in large animal models.

4. Left Atrial Appendage (LAA) Closure Devices
     · LAA Occluders: Devices designed to prevent stroke by occluding the LAA, evaluated for safety and sealing effectiveness.

5. Balloon Devices
     · Balloon Valvuloplasty Catheters: Used for expanding narrowed valves (e.g., pulmonary or aortic), tested for efficacy and complication rates.
     · Balloon Atrial Septostomy Catheters: Assessed for creating or enlarging interatrial septal openings.

6. Stents and Dilation Devices
     · Coronary Stents: Tested for deployment, patency, and tissue response.
     · Bioresorbable Stents: Evaluated for their temporary support and degradation rates.

7. Left Ventricular Assist Devices (LVADs)
     · Continuous Flow LVADs: Devices like the HeartMate series are tested for hemodynamic support, pump function.

8. Total Artificial Heart
     · Total Artificial Heart Systems: Such as the SynCardia device, tested for function and physiological responses in large animal models.

9. Implantable Cardiac Monitors
      · Loop Recorders and Subcutaneous Monitors: Evaluated for effectiveness in long-term monitoring of heart rhythms and arrhythmias.

10. Monitoring and Diagnostic Devices
      · Intravascular Imaging Devices: Such as optical coherence tomography (OCT) or intravascular ultrasound (IVUS), tested for their ability to visualize cardiac structures and pathology.

11. Robotic Surgical Systems
      · Robotic-Assisted Surgical Platforms: Evaluated for precision in surgical repair or replacement of heart structures in large animal models.

12. Thermal Ablation Devices
      · Radiofrequency Ablation Catheters: Used for treating arrhythmias, assessed for efficacy and safety in large animal models.

13. Bioprosthetic Materials
      · Tissue Engineering Constructs: Evaluated for developing replacement valves or patches, focusing on integration and function.

14. Surgical Tools and Techniques
      · Cardiopulmonary Bypass Systems: Tested for performance in maintaining circulation during surgical interventions.
      · Surgical Staplers and Sealing Devices: Assessed for effectiveness in cardiac surgeries.

15. Novel Technologies
      · Smart Stents and Sensors: Devices incorporating technology to monitor physiological parameters are tested for functionality and long-term performance.

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