Medical Devices & Imaging

The IHC staff has supported major IDE, PMA and 510K programs for numerous medical devices.

169264929-imagingWe have also conducted numerous trials utilizing medical imaging and diagnostic/screening technology in support of safety and efficacy claims.

International HealthCare (IHC) has managed the entire clinical program of several cardiovascular medical devices from direct stenting and drug-eluting stents, spine stabilizing devices, to the development of a vascular device to treat varicose veins.  Medical device trials require an added level of specialized service and regulatory knowledge to be executed successfully.  IHC understands the regulations required for PMA and 510K submissions, and therefore can assist your project team in designing the scope and breadth of those clinicals necessary to succeed.

The following is a brief overview of IHC’s experience:

Cardiovascular/Respiratory

  • Stenting: Safety, Efficacy and Registry trials – both regular and drug eluding products
  • ACT diagnostic tool comparative claims
  • Heparin-Induced-Thrombocytopenia (HIT) Antibody Test efficacy
  • COPD Patients Experiencing an Acute Exacerbation Requiring Ventilatory Support

Imaging

  • Mammography
  • Radiography
  • Endoscopy/Colonoscopy

Orthopaedics

  • Spine – Lumbar Stenosis
  • Sports Medicine – Cartilage Repair
  • Periprostehetic Joint Infections
  • IDE Pivotal Trials
  • Feasibility/Pilot Assessments

Endovascular

  • Stenting: Peripheral, Renal Salvage and Registry, Doppler & Duplex Imaging
  • Abdominal Aortic Aneurysm: Safety/Efficacy trial
  • Varicose Veins: Safety, Efficacy, and Imaging (Duplex Ultrasound Retrograde Blood Flow & Valving)

Surgical: Repair and Implants

  • Breast Implant and Scaffolding Repair
  • Parastomal Hernia Repair
  • Contraceptive Implant

Tissues

  • Human Tissue Matrix: Pre-IDE studies, Safety & Efficacy trials, Breast Cancer with Mammography
  • Porcine Tissue Matrix: Pre-IDE studies, Safety & Efficacy trials, Breast Cancer with Mammography
  • Colostomy & Breast Repair
  • Diabetic leg ulcers

Miscellaneous Devices

  • Basal Cell Carcinoma Laser
  • Gnathodynamometer Dental Sensitivity Diagnostic Device
  • Flushing Nozzle for Vaginal Cleansing and prevention of STDs and PID