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FDA Approves Boston Scientific's Emblem MRI S-ICD System

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The U.S. Food and Drug Administration (FDA) recently granted marketing approval for Boston Scientific Corporation’s (BSX - Free Report) Emblem MRI Subcutaneous Implantable Defibrillator (S-ICD) System, in line with management’s expectations. This approval added another device to this medical technology giant’s expanding product line of magnetic resonance imaging (MRI) – safe devices.

The approval also included magnetic resonance (MR) labeling for all previously implanted Emblem S-ICD Systems of the company; so that going forward all patients will be receive a MRI-enabled S-ICD system from Boston Scientific.

Notably, Boston Scientific’s Emblem S-ICD System safeguards patients, at risk of sudden cardiac arrest by not touching their hearts and vasculatures. Therefore this device has the potential to reduce the risk of complications associated with conventional transvenous implantable cardioverter-defibrillator leads.

Moreover, the Emblem S-ICD is 20% thinner and projected to last 40% longer than the company’s previous generation of S-ICD.

We believe the recent FDA approval for the next-generation version of this device – the one enabled for undergoing MRI, should enhance Boston Scientific’s position in the global multi-billion dollar cardiac rhythm management (CRM) devices market.

Apart from being MRI-safe, the device introduces two new features to the market – Smart Pass technology and Atrial Fibrillation (AF) Monitor. The Smart Pass technology, also being added to the earlier version through a software update, facilitates more enhanced therapy for patients only when necessary. The AF Monitor feature is a detection tool designed to alert physicians after the identification of AF so they can make more informed treatment decisions for their patients.

Per management, Emblem S-ICD has been a key contributor of the company’s top line growth during the recently reported second quarter of 2016, following the international launch of the Emblem MRI S-ICD system in Europe in Apr 2016.  Going ahead, the company plans to expand global utilization of its S-ICD systems with more long-term data from the Effortless Registry, growing physician implant experience and widespread expansion in demand for S-ICD systems.

Besides, the company expects this FDA approval will aid in neutralizing the near-term headwinds it has been suffering from the U.S. MRI high voltage segment.

With the CRM Devices market value currently expected to reach $20.9 billion by 2017, we expect Boston Scientific to capture larger shares of this market going ahead, banking on the recent FDA as well as CE Mark approvals for the Emblem MRI S-ICD. Additionally the growing demand for MRI-safe devices and the strong performance this medical device major has exhibited so far further buoys this optimism.

Some of the notable players in the medical space include NuVasive, Inc. (NUVA - Free Report) , Quidel Corp. (QDEL - Free Report) and Lantheus Holdings, Inc. (LNTH - Free Report) .

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