CRT unites FDA, industry, physicianswith an eye to Congress

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Ron Waksman, MD, CRT director. Image Source: Medstar Research Institute  

Washington, D.C.—The annual meeting of the Cardiovascular Research Therapies (CRT) held here last week took advantage of its proximity to the nation’s regulatory bodies by including lively discussions and workshops with the FDA.  

Due to the conference's convenient location in the center of Washington, it has the unique ability to bring together "all the relevant players, including government, industry and clinical and academic leaders,” said Ron Waksman, MD, CRT director, told Cardiovascular Business News.

This type of forum can help smooth out some rough edges, particularly with increased scrutiny of the ties between physicians and industry. “These types of conversations can only bring about more transparency,” Waksman said.

Next year, CRT hopes to have representatives from Congress, particularly the principals who are driving the increased scrutiny, he said.

To exemplify the current collaboration, Waksman pointed to the progress of percutaneous valve procedures—primarily on the aortic side—demonstrated through "very successful" live cases presented from Europe. These cases used the CoreValve ReValving system and the Edwards Lifesciences Sapien valve—neither of which are approved in the U.S.

The FDA panel that followed the live cases added to the "lively discussion, by suggesting how to move this technology forward, looking at what should be the next clinical trial and detailing how to implement the existing data, primarily on patients from whom surgery is not an option,” Waksman said.

He also noted the expansion of the show's schedule to include neurovascular, especially neuro-intervention for stroke. Waksman said that many of the presenters focused beyond carotid stenting, looking at ways salvage patients with acute stroke with neuro-intervention.

Participants were treated to tips and tricks for chronic total occlusions garnered from recent Japanese developments. And the live case demonstrations were a first for CRT.

For next year, Waksman said that CRT will continue to seek the next generation of leaders from the clinical/academic field. "This year, we invited 25 emerging leaders in the field of cardiovascular research to present at the conference. We hope to continue this tradition at future meetings," he concluded.