Boston Scientific Corporation (BSX - Free Report) recently announced that it has successfully treated the first patient under the ZERO AF clinical trial. This international, multi-center study is used to evaluate the performance of the Blazer Open-Irrigated Temperature Ablation Catheter in patients with symptomatic, drug refractory paroxysmal atrial fibrillation ("PAF").
The result of this trial, which includes 472 patients in 33 sites across the U.S., Europe and Asia-Pacific, is expected to be used to support a regulatory submission to the U.S. Food and Drug Administration ("FDA") for a PFA indication. While Blazer Open-Irrigated Catheter is approved for use in CE Mark countries and Canada, it is yet to receive approval in the U.S. This latest addition to the company’s Blazer catheters product line is Boston Scientific’s first open-irrigated catheter with a design to cool the entire tip of the electrode during radiofrequency energy delivery.
Atrial fibrillation is a rapid irregular rhythm affecting the upper chambers of the heart. This disorder is increasingly affecting nearly 15 million people globally, leading to complications like stroke or heart failure. Moreover, patients treated with anti-arrhythmic drugs often experience adverse side effects. In such cases, Catheter ablation is being used increasingly.
Revenues from Boston Scientific’s Electrophysiology business during the latest quarter were $35 million, down 2% on a year-over-year basis. The worldwide flat sales were due to the softness in both the small tip and large tip U.S. businesses, offset by growth in other segments including capital equipment, cooled ablation and diagnostics. However, in Oct 2012, Boston Scientific acquired Rhythmia Medical, Inc., which develops next-generation mapping and navigation solutions for use in cardiac catheter ablations and other electrophysiology procedures, including atrial fibrillation and atrial flutter. This acquisition is expected to strengthen the company's foothold in the electrophysiology ablation business.
However, the challenges at Boston Scientific’s core segments consisting of stents and defibrillators do not show any signs of abatement in the near term. The company continues to experience pricing pressure in the U.S. and Europe. Additionally, the softness in procedural volume due to economic uncertainties and competitive product launches remain concerns. This has affected other players in the MedTech sector as well, such as Medtronic (MDT - Free Report) and St. Jude Medical (STJ - Free Report) .
Despite the various ongoing headwinds, product launches made in the recent past should provide some cushion to its top line. Several other products are slated for launch over the year, which should benefit the top line.
We have a Neutral recommendation for Boston Scientific. The stock retains a Zacks Rank #3 (Hold).