Therapeutic Areas

Vascular

Vascular

Our team has the vast knowledge of vascular devices and the clinical trial processes required to secure market approvals and adoption. Our world-renowned vascular surgeons have expertise across a broad spectrum of indications and were national principal investigators on multiple, landmark clinical trials for medicine’s most innovative technologies.

Having been in the trenches of clinical practice, our team offers the perspectives of our clients’ physician and hospital customers, giving their innovative products the best chance of acceptance by the medical community at large.

Our Successes

Our vascular surgeons have long careers as investigators and scientific advisors to industry, enabling us to help generate the evidence needed for market approval and adoption.

                                                                                          

  • Clinical research partner of choice for over 50 vascular device companies
  • Strong track record for regulatory approval of full-service endovascular pivotal trials executed by Syntactx
  • 100% acceptance of Clinical Evaluation Reports according to Medical Device Directives and Regulations
  • Close relationships with Notified Bodies resulting in efficient guidance of our clients through MDD and MDR discussions.
  • Medical Writing for publications in Circulation and JACC on survival outcomes following treatment with drug coated balloons
  • Editors’ Choice, Journal of Vascular Surgery
  • Leadership at FDA Circulatory System Devices Panels

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