St. Jude gains FlexAbility approval, lays out 2015 sales growth strategy

St. Jude Medical ($STJ) has won FDA approval for its FlexAbility Ablation Catheter. This is the first irrigated ablation catheter with a flexible tip to be available in the U.S. The technology is used by electrophysiologists in the treatment of cardiac arrhythmias.

The design is intended to better conform to cardiac anatomy, enhance maneuverability to allow reach to anatomically challenging location, and enable effective lesion formation. The ablation catheter also has a new approach to irrigation flow to improve cooling and potentially reduce associated risks. An estimated 10.4 million people have some sort of cardiac arrhythmia, according to the company.

"The FlexAbility catheter is the only ablation catheter with a flexible tip available to electrophysiologists in the United States today," Dr. Andrea Natale, executive medical director at the Texas Cardiac Arrhythmia Institute, said in a statement. "For the past several years we've been looking for a catheter that provided a gentler, more optimal approach to ablation. The FlexAbility catheter addresses this need and provides me with another safe treatment option for my patients."

The FlexAbility catheter gained a CE mark last year. It joins the company's TactiCath Quartz contact-force sensing irrigated ablation catheter, which became available in the U.S. last year and is intended to give physicians a real-time measure of the force applied to the heart wall during a cardiac ablation procedure to treat paroxysmal atrial fibrillation (AF).

"TactiCath and FlexAbility are two unique catheter product lines that offer innovative solutions leading to effective outcomes, efficient procedures and more productive EP [electrophysiology] lapse," St. Jude chairman, President and CEO Daniel Starks said on the company's quarterly earnings call. "We expect customer preference for our ablation catheters to help pull through increased use of our entire portfolio of products using the EP Cath Lab."

The company's AF product sales were its strongest growing during the fourth quarter, up 12% to $283 million. Neuromodulation sales also gained 8% to hit $124 million in the fourth quarter compared to the same period a year earlier.

But structural heart and vascular products dipped 1% to $347 million, while the largest segment--implantable cardioverter defibrillator and pacemaker products--fell 3% to $685 million.

Overall, St. Jude net sales were up only 1% to $1.4 billion in the fourth quarter and 2% for the year to $5.6 billion.

Starks promised to improve on that growth rate this year. "The key to accelerating sales growth in 2015 is executing well on three growth programs: our CardioMEMS program, our AF ablation program and our Neuromodulation program in the United States." It expects $70 million in CardioMEMS product sales in 2015, which had $12 million in fourth quarter 2014 sales.

But the company offered revenue growth rate guidance of only 3% to 5% in 2015 on a constant-currency basis; that puts it right in line with the 2014 figure of 4%.

- here is the approval release
- and here is the statement on earnings

Special Report: So far, just 4 companies have a shot at winning the neuromodulation race - St. Jude Medical - Neck and neck with Boston Scientific