St. Jude Medical's Merlin cardiac rhythm management device programmer is critical to the firm's ambition to reach parity with competitors Guidant and Medtronic in the CRM segment, according to the firm.

Merlin, which the firm expects to launch worldwide within the next several months, "is a key part of our overall plan to take market share," St. Jude Cardiac Rhythm Management President Mike Coyle said during the firm's Feb. 10 analyst meeting.

According to Coyle, Merlin addresses a specific shortcoming that customers have detected in St. Jude's CRM line. "If I go out today and ask U.S. physicians or physicians in Europe, 'If there's a technology reason that you won't switch to St. Jude, what is it?', the thing I hear by far more than anything else is 'I don't like your programmer,'" he reported.

"'I don't like that you have to use the keyboard. I don't like the fact that it's slow. I don't like the fact that I have to dig into various screens in order to get where I want to go, and the fact is that I don't like having to learn your markers versus industry standard markers,'" Coyle recounted, urging "faster follow-up and faster learning, especially for people used to competitors."

St. Jude currently markets the Model 3510 universal programmer with its ICDs and pacers. The firm controls roughly 14% of the worldwide CRM market, led by Guidant and Medtronic, which have 37% and 48%, respectively (¹ Also see "ICD Coverage Decision Decoded For The Street: St. Jude Waxes In CRT Glow" - Medtech Insight, 31 January, 2005., p. 5).

The company has picked up four share points since introducing Epic HF and Atlas+ HF resynchronization defibrillators (CRT-D) and the Frontier II CRT pacemaker last summer. The firm has said repeatedly that in a few years the CRM market will be roughly equally split between St. Jude, Medtronic and Guidant.

"The focus of the [Merlin] initiative is to recognize two things fundamentally," Coyle stated. "Number one, physicians in the electrophysiology community are going to be extremely busy - ICD implants, ablation for atrial fibrillation - these are things we want to free up their time to do." He added: "The way we're going to do that is to take away overhead that is associated with follow-up of device [and to] design follow-up to be something much more efficient."

Second, Merlin will help physicians to more closely monitor CRM patients' disease and not constantly tinker with the device, Coyle said. "As we look into the five-year window, we want to change the way follow-up is focused. Today it is very much focused on the electrical parameters of the device, like capture thresholds, pacing amplitudes and PNR wave measurements."

"In the end, where we want to get to is where the devices do all the manual things themselves, allowing the physician to really focus his follow-up on what is the progression of disease within this patient."

The patient, not the device, is worthy of physician attention - for example, "what's going on with their atrial fibrillation, what's going on with their heart failure, what's going on with their apnea or their ischemia," Coyle said. He asserted that Merlin users can "get away from focusing on the electrical characteristics of the device by really automating it."

Merlin is "the largest product development effort that we've ever done as an organization in terms of the number of people involved and the expense associated with the development of both the hardware and software," he stressed. Roughly "500 clinicians and field clinical engineers were involved in the specification."

According to St. Jude, Merlin will be smaller, lighter and faster than any other CRM programmer on the market. It is the first such device with a 3 GHz processor and prints on standard eight-inch wide paper, instead of the unwieldy strips used by most other systems. The touch screen interface is designed in consultation with users around the world, Coyle noted.

The Merlin hardware, about the size of a small laptop computer, has ports for a microphone so the physicians can talk directly to St. Jude technical support staff. It also features a port for a device interrogation wand and WiFi card and Ethernet connection slots.

CRM is also simplified by remote monitoring networks such as St. Jude's HouseCall . St. Jude devices have been HouseCall-compatible since 2003, but the system rolled out nationwide in the second half of 2004. HouseCall has 1,000 patient transmitters linked with 60 centers and 100 physicians. The potential for HouseCall is portended by the growth of Medtronic's CareLink , first launched in 2001. CareLink now includes about 25,000 patients and 430 clinics such as 85 new centers in the last quarter. Guidant and Biotronik also offer remote patient management.

Merlin Programmer To Lure Customers Away From CRM Rivals – St. Jude

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