The cardiac rhythm management (CRM) market may be seeing a decrease in the number of high-energy devices being implanted — such as implantable cardioverter defibrillators (ICDs) and biventricular (BiV) ICDs — according to one expert in the sector. But sales of good old-fashioned pacemakers are still going strong.

Kenneth Ellenbogen, MD, an electrophysiologist in Richmond, Virginia, participated in a conference call Tuesday, hosted by Rick Wise, med-tech analyst for Bear Stearn, regarding trends in the CRM market.

Ellenbogen has a variety of strong credentials. He is vice-chair of cardiology at Virginia Commonwealth University (Richmond, Virginia) and his academic, clinical and research efforts include new ablation methods for atrial fibrillation (AF), new pacemaker development, and exploring the role of pacemakers in treating congestive heart failure and AF. He also serves on the editorial boards of the Journal of the American College of Cardiology, American Journal of Cardiology, American Heart Journal, Journal of Cardiovascular Electrophysiology and is one of the senior editors of PACE.

Ellenbogen began by telling conference call listeners about what the device volume in the CRM sector has been doing at his university medical practice in Virginia. "[O]ur volume has grown incredibly over the last five to six years," he said. "In fiscal year 2005 [from July 2004 to July 2005] we put in 384 devices. Fiscal Year 2006 was a bonanza of a year — we did 455 devices."

But so far in FY07 through March, three quarters of the fiscal year, Ellenbogen said his practice put in 322 implantable devices and he predicted its device volume at 400 to 410 by the end of this fiscal year.

"So our total device volume should be down about 10%," Ellenbogen said.

While pacemaker volume is strong, Ellenbogen said he's noticed a decrease in the volume of high-energy devices such as ICDs and BiV ICDs.

"I don't see the same number of good candidates that I saw before" for primary prevention ICDs, Ellenbogen said. "Also, [there is] a certain pool of patients with heart failure who are candidates for biventricular ICDs or [cardiac resynchronization therapy] ICDs, and I think that pool really peaked a year or two years ago for us, and now it's slowing down."

For example, Ellenbogen said in 2005 his practice put in 83 BiV ICDs compared to 100 BiV ICDs in 2006 and has only put in about 57 BiV ICDs in the past three quarters. So, he noted, the practice's BiV ICD volume is going to be closer to 75 or 80 by the end of this fiscal year rather than 100.

"So [in] Fiscal Year 2006 we were putting BiV ICDs in right and left, and we'll probably barely hit 80 this year, so that's gone down a lot," Ellenbogen said. "It's been steady, but it definitely isn't like it was last year when we were just going crazy putting these devices in."

Another example: He said his practice put in 144 primary prevention ICDs in FY05, 184 in FY06 and are up to about 130 so far in FY07. "So our ICD volume has gone down also by about 15%, whereas our pacemaker volume is really quite good."

In 2005 Ellenbogen's practice put in 126 pacemakers, he said, compared to 143 in 2006 and they have been putting in 13 to 15 pacemakers a month this year, representing a 10% to 15% growth, he said.

Ellenbogen also discussed where he believes certain companies stand in terms of market share.

"Guidant's (Indianapolis) market share is stabilized, it is not down though. Over the last year or two we've just sort of stabilized Guidant — they have about 30% of our market. St. Jude (St. Paul Minnesota) has grown every single year over the last three years from 7% to 13% to 16% or 17% now. Medtronic (Minneapolis) is about 50% — they used to be 62% and now they're in the 50s," Ellenbogen said.

But whether or not the trend will continue over the next couple of years will be hard to predict, he said.

"I think Guidant has really been hurt by the FDA in the fact they've had very, very, very few new products in the last two years so I could see Guidant potentially growing. It depends what products they come out with," Ellenbogen said.

In comparison, St. Jude will introduce 20 to 30 new products in the next couple of years, he said, and Medtronic also will make some product introductions.

"But I'd just have to see who comes out with what, and when do they come out with it," Ellenbogen said. "I would feel uncomfortable sort of increasing our Medtronic market share now, while St. Jude in particular has so many new products coming out."

Switching to emerging technologies for AF, Wise asked Ellenbogen: "Who's doing what in atrial fibrillation that you're interested in on the company side?"

Ellenbogen spoke highly of CryoCath Technologies (Montrael), especially a clinical study that company is doing with a balloon. "I am very interested in Cryo. I think the clinical study that is being done by Cryo is potentially a major breakthrough in the field of atrial fibrillation . . . they are doing a clinical trial with a balloon," Ellenbogen said.

A caveat: When asked to disclose his conflicts of interests, Ellenbogen acknowledged being directly involved in the Cryo study as an investigator at one of the study's 20-25 sites. But he said he had not yet done any cases and so had no personal knowledge about the technology.

He added that one of his close friends has done eight or nine of the cases and is "very impressed."

The Cryo balloon is already available in Europe and the company seems to think it is doing well there, he said. He noted that in the U.S., the clinical trial is ongoing and the FDA has mandated a year follow-up and so device approval is not expected before 2009.

When and if the device is approved, Ellenbogen said Cryo would have to pump up its manufacturing of the consoles significantly and may have to do a lot of training which, he said, could take years. But, he added that he thinks the device has "good possibilities" because of its safety.

"The whole rationale of the Cryo balloon is that we could be ablating about 400,000 to 500,000 patients a year who have AF, and we're [currently] ablating about 5,000 or 6,000 patients a year, and the reason is because it's technically difficult to do and most people feel uncomfortable," Ellenbogen said.

"So if they can make it easy for every Tom, Dick and Harry to do and make it safe and easy, then a lot more people will want to do it."

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