|St. Jude Medical's TactiCath Quartz ablation catheter--Courtesy of St. Jude Medical|
St. Jude Medical ($STJ) snagged FDA approval for its next-generation ablation catheter for atrial fibrillation, bolstering the company's presence in a growing electrophysiology market and strengthening its footprint in the cardiac rhythm management sector.
The St. Paul, MN-based device giant got a regulatory green light for its TactiCath Quartz irrigated ablation catheter, a thin, flexible wire that allows physicians to estimate in real-time the amount of force being applied to heart walls during ablation procedures. The product includes St. Jude's EnSite Contact System, cardiac mapping and navigation technology that features 3-D mapping and navigation and helps doctors modify the force during the procedure to create more effective lesions.
The FDA based its approval on data collected from TOCCASTAR, a clinical trial of the device that found that 85.5% of patients were free from paroxysmal atrial fibrillation (AF) at 12 months after being treated with TactiCath, as opposed to 67.7% of patients who were treated with different ablation catheters. An estimated 2.7 million people are impacted by atrial fibrillation, making it the most common form of cardiac arrhythmia in the U.S., St. Jude said in a statement.
"St. Jude has a long history of introducing leading ablation technologies to the electrophysiology community," St. Jude group president Eric Fain said in a statement. "This approval speaks to our commitment to investing in and developing world class, cost-effective solutions that are backed by clinical evidence in order to improve the quality of care for millions of patients impacted by atrial fibrillation."
The regulatory blessings comes at a critical moment for St. Jude, as the company counters a slump in international sales and pushes for development of new technology. Earlier this month, the devicemaker reported a 3% gain in net sales of $1.37 billion for the quarter compared with $1.34 billion for the same period last year, but also faced a 2% drop in international CRM sales. St. Jude is looking to recent acquisitions of heart monitoring outfit CardioMEMS and pain management therapy manufacturer NeuroTherm to expand its offerings and swing its numbers northward, the company said in a Q3 earnings call.
- read the release (PDF)
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