FDA Trials

What is an FDA Clinical Trial?

Many cutting edge surgical technologies that serve thousands of American patients today undergo a rigorous and lengthy process called Investigational Device Exemption (IDE) clinical trials.  IDE trials typically involve several hundred patients at multiple investigational locations, and can take between 5-10 years to complete.  Patients are enrolled under very specific guidelines and followed closely for the duration of the study.  Only patients that are enrolled in the clinical trial have access to the investigational treatment until it is reviewed and approved by the FDA for commercial use.

 

Paradigm Surgical Devices – involvement in FDA Trials:

Randall Lee was exposed to the importance of supporting IDE trials within the operating room over two decades ago.   The team at Paradigm Surgical Devices was chosen after a detailed vetting process to provide local case coverage in the Dallas area for the Spine Core-C and Spine Core-L clinical trials.  The detailed and technical service provided by Paradigm was so valuable, they were asked to provide support for the Spinal Motion Kineflex-C and Kineflex-L trials in DFW. Paradigm was then approached to provide case coverage support for the Coflex device IDE Study in 3 sites across Texas. Shortly thereafter, Paradigm was requested to provide support for the Spinal Kinetics M6 trials in 2 separate sites in Texas.  Most recently Paradigm Surgical has been asked to provide case coverage support in 4 U.S. sites in the Simplify Cervical Disc clinical trials, both 1 and 2 level studies (currently ongoing).
 

Paradigm Surgical is one of the few, select organizations that has been chosen by multiple medical device manufacturers to help support their IDE trials.  Responsibilities of clinical study management include:

  • Technical and clinical expertise with the device and surgical technique
  • Training of the surgeons and hospital staff about the study protocol and product installation
  • Operating room coverage for all study cases
  • Diligent reporting and record keeping of study device use
  • Secure storage and delivery of the study devices

 

FDA trials that Paradigm has supported include:

Spine Core-C Cervical IDE Study - DFW Case Coverage Support

Spine Core-L Lumbar IDE Study - DFW Case Coverage Support

Spinal Motion Kineflex-C Cervical IDE Study - DFW Case Coverage Support

Spinal Motion Kineflex-L Lumbar IDE Study - DFW Case Coverage Support

Paradigm Spine Coflex Lumbar Motion Preserving IDE Study - 3 Sites in Texas Case Coverage Support

Spinal Kinetics M6 Cervical IDE Study - 2 Sites in Texas Case Coverage Support

Simplify Medical 1 Level Cervical IDE Study - 4 US Sites Case Coverage Support

Simplify Medical 2 Level Cervical IDE Study - 4 US Sites Case Coverage Support