Medical Device Daily Associate

St. Jude Medical (St. Paul, Minnesota) yesterday reported FDA approval of what it calls a “universal“ new programmer for its implantable defibrillators (ICDs) and pacemakers.

The device, called the Merlin patient care system, is designed to help physicians more efficiently conduct tests, analyze therapeutic and diagnostic data, and program implanted devices for optimal patient care.

Merlin – which will be launched over the coming weeks – supports both current and previous generation devices and represents what the company banners as a “significant market launch for St. Jude Medical and one of more than 20 new cardiac rhythm management products expected to be introduced this year.“

Kathleen Janasz, company spokesperson, emphasized that the system is “universal“ only in the sense that it can be used for most St. Jude ICDs and pacemakers and is not designed to work with competitors' devices. But she emphasized also that it was a large step forward for the company's products.

“This programmer really resets the bar for patient care systems, and it goes further than just the typical programmer in that it's more efficient in how it conducts tests, how it analyzes data and how it supplies that data to the physician or the nurse who is conducting the tests and doing the follow-up visits,“ Janasz told Medical Device Daily.“ She added that the new programmer does these things “far faster than any previous versions that were available.“

The company noted that the Merlin system is a powerful, portable computer that helps physicians retrieve and analyze patient information during routine follow-up visits. It has been designed so that physicians can quickly make changes to device therapy through an LCD touch-screen.

The system's intuitive workflow should increase productivity for physicians and clinic staff, according to St. Jude. With the Merlin, patients should receive the same high standard of care, but with follow-up visits taking significantly less time, it said.

Perhaps the most important critical new component of the Merlin, said Janasz, is its touch screen system, designed based on conversations with clinicians to better understand what the typical patient follow-up visit entails.

“After determining what it was they needed and how they wanted to proceed, we developed the workflow of this system to mimic that,“ she said. This means that as clinicians walk through a follow-up visit, “this screen intuitively moves through the visit in the same way.“

Janasz also noted that the Merlin, weighing in at about 24 pounds, represents a highly portable alternative to past programmers, particularly when considering that it “has more power,“ pound for pound. “I'm not sure that there's anything that is as powerful as this or as fast as this,“ she said.

Carlos Rizo-Patron, MD, of Cardiac Arrhythmia Services (Lubbock, Texas) provided a physician perspective of the system.

“We're seeing a growing number of patients with implantable devices that need follow-up testing.“ And he said the Merlin allows for conducting more follow-ups “in less time with a high degree of patient satisfaction.“

This interface (including the aforementioned touch screen system), is currently available for pacemakers and is expected to be available for ICDs later this year, with additional upgrades also expected for the ICD environments.

Another of what the company calls “industry firsts“ for this new system is a session screen which shows a summary of tests performed during a pacemaker patient's follow-up exam, as well as a comparison between presenting settings and currently programmed settings. This feature also is expected to be available for ICD patients later this year.

The system, which will be compatible with future ICDs and pacemakers, Janasz stressed, “is more of a patient care system.“

She compared the traditional programmer to an old-fashioned computer system and characterized the interactive touch screen of the Merlin system as far more intuitive and easier to use. “This new system takes the patient information and puts it “quite literally at [clinicians'] fingertips,“ she said.