Boston Scientific's Heart Device Wins FDA Nod, CE Mark - Analyst Blog
Boston Scientific Corporation BSX continues to stay in the headlines with its array of innovations and product launches. Recently, the company simultaneously won the U.S. Food and Drug Administration (FDA) approval and the European CE Mark for its Emblem Subcutaneous Implantable Defibrillator (S-ICD) System – the first-line treatment option for patients at risk of sudden cardiac arrest (SCA).
Following the CE Mark, a controlled and limited market release will be held in Europe with a full-fledged launch scheduled thereafter in May 2015. Also enthusiastic about the earlier-than-expected FDA approval, Boston Scientific expects the U.S. launch of the device in the third quarter of 2015.
According to Boston Scientific, this second generation S-ICD System can be placed just under the skin. It provides the patient the same protection from cardiac arrest as conventional transvenous implantable cardioverter-defibrillators (TV-ICDs). However, it leaves the heart and vasculature untouched thus minimizing the risk of complications associated with TV-ICDs. In addition, the company expects this EMBLEM S-ICD System to last 40% longer than the previous S-ICD System.
Management notes that, Boston Scientific is the first and only company at the moment to offer a fully subcutaneous ICD. The company hopes to maintain its leadership in this category, going ahead, through continued investment in technology and clinical science.
Despite challenging economic conditions, a competitive environment, pressure on core segments and a larger-than-expected currency headwind, Boston Scientific has managed to proceed successfully with its strong pipeline of products. In the U.S., the company’s ICD business continues to deliver solid growth on the back of consistent momentum in the S-ICD segment with steady adoption of S-ICD MINI.
We expect Boston Scientific’s S-ICD to yield strong growth in 2015 as well with the expansion of reimbursement coverage. The recent FDA clearance and CE Mark for Emblem S-ICD should continue to boost momentum further in this segment.
Zacks Rank
Boston Scientific currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the medical products industry are Abaxis, Inc. ABAX, LeMaitre Vascular, Inc. LMAT and Phibro Animal Health Corporation PAHC. All the three stocks sport a Zacks Rank #1 (Strong Buy).
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