In the early days of the Drug-Eluting Stent market, we were turned to by many start-up enterprises to design their IDE DES clinical trials, as a clear pathway for these emerging devices was lacking at the time.
As an academic research organization (ARO), we are probably best known for our work in the stent space, which began in the late 1990s. Today, we maintain this focus on stent and trial design in general, by employing novel approaches that consider safety and efficacy as well as real-world applicability.
If one looks at the history of the bare metal stent (BMS) era (beginning with the second generation) and the drug eluting stent (DES) era that immediately followed, our role and impact are highly apparent. The following table provides an overview of our involvement in the development of these breakthrough therapies.
The Bare Metal Stent Development Era (2G)
The Drug Eluting Stent Development Era
This close engagement with the organization during the product lifecycle enabled our team to possess superb familiarity with the device and its data and at the same time developed a pathway that satisfied the FDA’s requirements. This working relationship also formed a partnership with these companies that enabled a close working relationship between our respective teams. This resulted in many PMA approvals for device number of companies in this competitive space, beginning with the first of multiple generations of the device. Because of the highly entrepreneurial nature of this industry, many individuals have worked with us on a serial basis – as they move on to new startup ventures they turn again to us to help with their needs as they start to contemplate trial design, FDA interactions and trial operations.