WASHINGTON — Transcatheter Cardiovascular Therapeutics 2007 is the major medical conference of the week. But the discussions often seem straight from Court TV — or “Law and Order.”

Steve Phurrough, MD, director of the coverage and analysis group at the Centers for Medicare and Medicaid Services, said that product sponsors should bear in mind a regulatory version of the real estate maxim of “location, location, location.” “When you bring new technology to us, there are three questions,” he said.

The first question is, “Is there good evidence?” And the second and third questions are: “Is there good evidence?”

And so it went on one of the TCT 2007 panels, the members debating, judge and jury-like, the best evidence for your regulatory case, when to gather it, how to present it.

“There’s a real issue in that it costs a heck of a lot of money” to conduct a trial for a medical device that will render good evidence, Phurrough said, but he cited a lack of innovation in trial design.

“There needs to be thought around how we think innovatively about trial management” and data collection. And, in the “gap between the time at which a trial ends” and FDA approval, “[i]t seems to me you should know what you’ll need” to obtain reimbursement, he said.

One of the more vexing emergent problems is that “devices are becoming more technically difficult to use,” and the “provider population” able to use them is shrinking, he said.

Non-randomized trials can add to data sets that will give CMS a reason to issue a national coverage decision, but Phurrough acknowledged the difficulty of collecting detailed data from other study types and study sites outside the U.S.

“I think there needs to be some broad, industry-wide discussion” on trial design and the underlying aim regarding data collection.

Phurrough said that registries can help, and “we stand ready to engage you in conversation,” but he reminded the audience that CMS “is not the agency that can make pronouncements as to how that can occur.”

Paul LaViolette, chief operating officer at Boston Scientific (Natick, Massachusetts), offered a list of industry issues rather than recommendations regarding trial design.

“Its clear that FDA and industry are linked in a battle for [product review] resources,” and that as the number of new products continues to rise, “we all have a sense that the regulatory challenge is intensifying.”

LaViolette said the first time someone suggested reclassifying angioplasty balloons into class II — which would make them 510(k) devices — was eight years ago, and he recommended a greater effort to properly allocate devices to their risk.

For business planning, he said, “the biggest problem with execution is uncertainty” concerning FDA expectations, noting that about $750 million will have been spent on stent R&D between last December’s meeting on the stent regulation and “the middle of 2008,” when the agency’s guidance on stenting is expected.

LaViolette said that another useful move by FDA “would be to tighten the guidance process,” though acknowledging that guidance development drains the agency’s human resources needed for PMA reviews.

Still, the guidance is crucial, he said, because “in the past 12 to 18 months, stents have introduced unprecedented controversy,” and, as a result, “next-generation technology ... has to pass a higher bar because of a perceived problem.”

LaViolette recommended that the agency “avoid shifting legitimate post-market questions to the pre-market stage” of the PMA review process.

He described the perception of the various vasculatures as distinct organs as wasteful. “Is a 2.4 mm vessel really going to act differently than a 2.5 mm vessel? For similar vascular systems or similar manifestations of vascular disease, we should try to apply common sense.”

And he called the differentiation of vasculature as “the antithesis of good resource deployment.”

Panel moderator Mitchell Krucoff, MD, a professor of medicine at Duke University Medical Center (Durham, North Carolina), asked, “Are we ready for a world where we have a reliable post-market environment with teeth?”

Bill Maisel, MD, of Beth Israel Deaconess Hospital (Boston) and chair of the December FDA advisory panel meeting on DES, said he saw “no issue with the delivery of data” from post-approval studies (PAS).

“For me, the issue is that we can do better in getting that data more quickly,” by being collected on an interim basis. “We also need to get creative” and “develop a framework ... to start contributing to some sort of universal way” to collect post-market data.

Bram Zuckerman, MD, director of the cardiovascular devices office at CDRH, said that FDA is making “a serious effort to construct a matrix organization” that will coordinate data from both ends.

Regarding an earlier remark about the lag time between CE marks and FDA approval, he said, “we get into this habit of using the CE mark as the gold standard” for device approval. “One has to realize that key data [leading to CE marks] were developed as a result of our current regulatory system.”

Would industry want to deal with post-approval action by FDA?

One panelist opined that such a scenario would result in a “slower, more expensive development process,” and that “not only are we ready, but we’re in that world today.”

LaViolette said, “we’re trying to live in a binary world in which a device is approved or its not.”

He suggested that industry and FDA work toward a “continuum” that would speed quicker product movement to to market. “The data intensity in this field,” he said, “is much higher than in any other device category,” thus enabling this.