Staff Writer

ATLANTA — Just how is interventional radiology thriving in countries whose healthcare systems measure quality and outcomes as a way to control costs? A panel at this year's Society for Interventional Radiology (SIR) meeting held in Atlanta tackled this point head on as radiologists from across the globe spoke on regulatory issues and reimbursement barriers.

"The question that's before this part of the panel is, can interventional radiology exist without the tools," James Spies, chairman and chief of service at Georgetown University Medical Center (Washington), who served as the moderator for the panel asked the audience. "Really the better question is what are the barriers in getting the tools that we need. The barriers that we have are actually different depending where we are in the world."

Marc Sopoval, head of the interventional radiology department at Hopital Europeen Georges Pompidou University Paris Descartes, tackled the first question focusing specifically on the CE mark. Sopoval said that he could only speak from the perspective of France when it comes to the CE mark - and not the other countries in Europe that the regulatory approval might cover. Sopoval told the audience that many companies from other countries are coming to gain CE mark.

Spies asked Ricardo Garcia-Monaco, of the Hospital Italiano (Buenos Aires, Argentina) what he thought were some of the main issues and problems of bringing a device forward to market in Italy.

"First of all there is not a local manufacturer here," Monaco replied. "Most of the devices come from other parts of the world and they should have [gone through] the regulatory process."

Mathew Cherian, chief of radiology, Kovai Medical Center & Hospital (Tamil Nadu, India) noted that India was in a very interesting state. He noted that prior to 2011 using an already approved device was relatively simple.

"Before 2011, things were kind of easy for us because any product that had CE mark, or anything that was FDA approved, was allowed to be used in any hospital. We did not have to have the data on this to [use these products]. But in 2011, the government of India brought in a new rule saying that every product that had to be used had to be reviewed by [India's] regulatory agency."

Cherian noted that there were notable products that had been used for more than 20 years, but had to be taken off the market to meet with these regulatory guidelines. He said "That to us was crazy."

"That's a big problem that we are facing now, and that's getting a product that's available in the world market for use to come back to us," he said. "It takes three to four years for the product to get back to us."

Cherian said that another issue India faces is that there are hardly any medical products manufactured there.

"That's a huge problem for us – obviously because of the price gap that takes place," he said. "For us in interventional radiology, it is a primarily a struggle in terms of getting indigenous products to solve the problem."

In the U.S. there are still significant lag times in the regulatory cycle said Katharine Krol, a vascular & interventional radiologist, and past president of SIR.

"Getting FDA approval doesn't necessarily mean you're going to have access to that product," she said. "You're going to have to jump over the reimbursement policy issues as well. In order to get a code in order to get paid, you have to have FDA approval and you also have to have a certain amount of literature already published. And you have to have it perform in a widely geographic distribution so that when you're doing it the procedure is pretty well defined."

DJ Sirota, VP, Global Business Unit Leader at Cook Medical (Bloomington, Indiana) said that from an industry standpoint, firms were inundated by the different regulatory issues from various regions.

"I think one of the issues is that there are so many regulatory agencies now that we have to deal with from the industry side," he said. "In 2000 there were about 20 different countries that had regulatory agencies today there are more than 60 and everybody has different requirements. It would be nice for industry to see some sort of global harmonization."

The session then transitioned onto the topic of China. David Chen, executive chairman at Scion Medical Technologies (Boston/Shanghai), spoke to the audience about some of the changes that firms and industry face in China.

"Like everyone else, China is a very large market and it is a very complex market. If you had to say what was one of the important aspects of device adoption, I think number one would be regulatory," he said. "Obviously, you have to understand the regulatory path; the kind of classification for the device and also the approval process. Number two is the distribution system, which is very complex. You have to work very closely with physicians."

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