CRT chair praises meeting as best for interactive discussion
|CRT 2008, February 11-13th at Omni Shoreham Hotel in D.C. Source: www.crtonline.org|
Keynote speaker Tim Russert, the well-known host of Meet the Press, had to cancel his engagement, which had been planned a year in advance, because of the importance of the Feb. 12 primaries. Ex-White House press secretary Tony Snow filled in, making the evening his own. By the conclusion of his speech, it seemed few in the audience remembered the absent Russert.
The Omni Shoreham Hotel registered more than 1,550 attendees for the meeting, a 12% increase over last year, and participants had ample opportunity to rub elbows with representatives from the FDA and industry.
Meeting chair Ron Waksman, MD, associate chief of cardiology at Washington Hospital Center, said a highlight of the meeting is the interaction with the FDA. This open forum allows industry and the government to exchange ideas to help expedite the medical devices approval process.
Various devices have different requirements and these forums give industry an opportunity to hone in on particulars for their technology. It’s a terrible waste of money and resources to spend years in clinical trials only to have the FDA point out missing components in the eleventh hour, Waksman said.
One session with the FDA focused on percutaneous valve therapy. Industry and physicians involved in these investigations are sometimes not clear about requirements of the device before it goes to trial, as well as the best design of the human trial to assess the technology.
“I think to a great degree many representatives from industry and physician investigators had their questions satisfactorily answered this week,” Waksman said. “The FDA wants to work with the technology community. That was very evident from these focused sessions.”
Another highlight pointed out by Waksman was the discussion with the FDA regarding drug-eluting stents. This is particularly pertinent because some studies have suggested that DES are responsible for late stent thrombosis.
While it’s still unclear whether DES or early termination of anti-platelet therapy cause late thrombosis, the FDA is taking no chances. Representatives talked about the agency’s new DES guidance document to be released soon. One focus of the new document is the required follow-up study time, which, in some cases, will be extended up to two years.
Waksman also highlighted the unique design of the meeting. Participants rotate from room to room to sample the concurrent sessions, each focusing on a topic such as chronic total occlusion, percutaneous valve therapy, and coronary interventions from various angles including new technology, basic science, and clinical trials.
“This design helps attendees get the most out of the meeting,” he said. “It gives them plenty of opportunity to speak with lecturers and colleagues about practical ways to solve current clinical challenges or prepare for upcoming changes.”