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'Smart' Cardiac Catheter Could Speed Arrhythmia Treatment, Improve Safety

By Christine Leccese, for Health Leaders Media  
   March 09, 2011

A promising "smart" cardiac catheterization device could cut catheterization procedure time for arrhythmias in half, while dramatically improving safety and efficacy new research shows.

Researchers published details about the device in the March issue of Nature Materials. The device, tested in animals at academic medical institutions in the U.S., is slated to undergo human trials in a year to 18 months, and researchers hope it will be available for the U.S. market in 2 or 3 years.

The catheter combines diagnostics and treatment ability in one device by having tools electronically "imprinted" on a standard balloon catheter. These tools give feedback to surgeons that allow them to proceed with greater precision, and enable them to eliminate tissue damage.

Researchers theorize that with the new catheter, the procedure of taking care of cardiac arrhythmias, which can take about two hours, may be reduced to an hour or less. The current treatment for patients with cardiac arrhythmias requires that doctors insert at least two catheters. One is used to map where the arrhythmias are happening, and the other is used to ablate abnormal tissue. The new device has dual functionality, offering "map and zap" technology.

"Our goal is to make the procedure as short as possible," says Dr. Rooz Ghaffari, co-founder and scientist at MC10, the Cambridge, MA-based company that is developing the product. "If you can combine sensing and therapy onto one device, that is the path to making it faster."

This is good news for hospitals, cardiologists, and patients since shorter procedures are generally safer. A longer procedure comes with a higher risk of blood clots or stroke. It also requires the patient to be sedated longer, which has its own risks.

"If you look at rates of morbidity in these procedures, they closely correlate to time," says John Rogers of the University of Illinois at Urbana-Champaign, one of the researchers who developed the stretchable electronics. "Anything that you can do to make this faster is safer. And, it requires a lot less skill on the part of the surgeon."

In addition to being significantly faster, and potentially safer, the device may also deliver  greater efficacy. Since the device will be able to give the cardiologist feedback, he or she will know exactly how much tissue they need to ablate for greater precision. "We currently give a dose that we think is right," said Dr. Marvin Slepian, M.D. at the University of Arizona, and a lead researcher on the project. "Sometimes, it's too little and sometimes too much. Being able to have additional intelligence in terms of the amount of energy being dispersed would tell us about appropriate dosing, history, and control."

Dr. Slepian talked about what this kind of technology means to hospitals and practice managers. "The implication of this is huge on all levels," he said. Greater efficacy means fewer complications, more success, and fewer rehospitalizations. He adds that, on a practical level, there will be fewer catheters on the shelf taking up valuable hospital storage space, and the instant feedback from the device means less time in the lab.

Because the catheter is not technically a new therapy, but only changes the way a therapy is delivered, it will likely be considered by the FDA "substantially equivalent" to a device already on the market. That means approval could come within the next 12 to 18 months.

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