FDA Clears Boston Scientific’s Heart Devices

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Boston Scientific Corporation (BSX) continues to remain in the headlines with its innovations and product launches. Recently, the company won the U.S. Food and Drug Administration (FDA) approval for a bunch of defibrillators and heart failure devices. According to the company, this latest line of advanced devices will successfully help Boston Scientific to further strengthen its foothold in the ever-growing and still untapped cardiac medical devices market.

The aforementioned devices comprise the Mini family of defibrillators including Dynagen Mini and Inogen Mini ICD, and the X4 line of quadripolar CRT-Ds (cardiac resynchronisation therapy with defibrillator function) – Dynagen X4 and Inogen X4.

With the X4 line of quadripolar CRT-Ds which have the largest battery capacity in the industry and sport a six-year warranty, Boston Scientific expects to offer 70% more pacing options that could effectively target the unmet need for high capture thresholds and phrenic nerve stimulation. On the other hand, the new Mini ICDs are claimed to be 20% smaller by volume and 24% thinner than their competitive products thereby providing more patient comfort. According to the company, these ICDs are helpful in treating life-threatening arrhythmias of the heart.

With an abysmal number of nearly 400,000 out-of-hospital cardiac arrests that occur each year in the U.S. alone, we expect these newly approved products of Boston Scientific to successfully address the untapped patient population and reduce the cost of healthcare.

Despite challenging economic conditions, competitive environment, pressure on core segments and a larger-than-expected currency headwind, Boston Scientific has managed to successfully move on with its strong pipeline of products.The company has begun the year 2014 on a good note with the launch of the OffRoad Re-Entry Catheter System in the U.S and the receipt of a CE mark in Europe for its WallFlex Esophageal Stent in February.

Thereafter, Boston Scientific obtained the CE mark for its REBEL Platinum Chromium Coronary Stent System and Ingevity MRI Pacing Leads in March. Earlier this month, the company also got the FDA and CE mark approval for the Expect Slimline (SL) Needle which will be used for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA) procedures.

Currently, Boston Scientific carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the medical product sector areEnzymotec Ltd. (ENZY), St. Jude Medical Inc. (STJ) and Edwards Lifesciences (EW). Enzymotec sports a Zacks Rank #1 (Strong Buy) while St. Jude Medical and Edwards carry a Zacks Rank #2 (Buy).

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