St. Jude Medical has received approval to sell a device that should let doctors more accurately perform ablation procedures that aim to correct an irregular heartbeat by destroying tiny bits of tissue.
St. Jude, based in Little Canada, announced Monday that it received approval from the Food and Drug Administration to sell its TactiCath Quartz ablation device, which promises to replace doctors' blind sense of touch during ablation with a readout on a screen.
The device is intended to cut down on the high need for repeat surgeries to treat atrial fibrillation, one of the most common heart conditions in the world.
Like all ablation catheters, the TactiCath Quartz includes a long wire tipped with an electrode that is snaked to the heart through an artery, typically from the groin. An electrophysiologist can use the electrode to intentionally create scars in the tissue responsible for conducting the electrical signals that cause a patient's heart muscles to misfire, or fibrillate.
Blocking those irregular signals with a lesion is supposed to stop an erratic heart rhythm. But an article in the journal Innovations in Cardiac Rhythm Management this month found that one-year success rates top out at around 60 percent for first-time patients. That means at least two in five patients would need second procedures to get the benefit of the therapy.
Contact-force between the catheter tip and the heart tissue is a factor in the success rate, but a means to measure that force has been elusive.
With older ablation catheters, the doctor has to guess how much pressure he or she is applying, based on the feel of the device in the hand during the procedure. TactiCath features a real-time measure of the contact-force pressure, which appears as a readout on the screen of St. Jude's heart-mapping device, the EnSite Velocity System.
"Creating permanent contiguous lesions has always been difficult, but through evolution of catheter tip design incorporating [contact force] measurement, this is becoming easier," the authors of the paper in Innovations in Cardiac Rhythm Management wrote.
The authors were from hospitals in the United Kingdom and Germany. The article, which was not supported directly with industry money, featured TactiCath and a competitor device made by Biosense Webster called the SmartTouch Thermocool.
Joe Carlson • 612-673-4779
Twitter: @_JoeCarlson
