St. Jude Medical Inc. (STJ) revealed that it has received Conformité Européene (CE) Mark approval of updated labeling for its Tendril STS and IsoFlex Optim pacing leads. Leads are an important part of pacemaker implantation procedures.

St. Jude Medical’s Tendril STS and IsoFlex Optim leads are used with the Accent MRI pacemaker. The approval would allow patients using the devices gain access to magnetic resonance imaging (:MRI) scans.

Leads are thin insulated wires placed through the vein where the tip is attached to the heart tissue and the other end connects the pacemaker. They carry electrical impulses from the pacemaker to the heart and transmit information from the heart back to the implanted device.

The Tendril STS and IsoFlex Optim pacing leads are based on the Tendril and IsoFlex lead platforms. It features St. Jude Medical’s exclusive Optim insulation material.

Optim insulation is basically a hybrid insulation material that combines the high-performance silicone rubber with the tear and abrasion resistance polyurethane. The combination provides enhanced durability and improves flexibility, handling and control during pacemaker implant procedures.

The Tendril STS and IsoFlex Optim pacing leads were originally designed to be used in an MRI environment. These pacing leads have shown proven reliability with over 99% survivability in patients. So, the updated labeling just demonstrates the safety of these pacing leads further.

About one million pacemakers are implanted each year across the world. St. Jude Medical is devoted to providing more MRI compatible pacing solutions to patients and physicians around the globe.

As a result, St. Jude Medical plans to seek updated labeling for many of its other products, which allow patients the ability to safely undergo MRI scans. The company plans to submit testing data in Europe, Japan, Australia and the U.S. for MRI conditional labeling on products including the Fortify Assura implantable cardioverter defibrillator (ICD), Ellipse ICD, Quadra Assura cardiac resynchronization therapy defibrillator (CRT-D), Durata and Optisure defibrillation leads.

Recently, St. Jude Medical received both U.S. Food and Drug Administration (:FDA) clearance and Conformité Européene (CE) Mark approval for its percutaneous coronary intervention (PCI) optimization system, OPTISTM.

OPTISTM Integrated System is the first PCI optimization system across the globe to offer optical coherence tomography (:OCT) and angiography co-registration, which supports procedural decisions by providing high-resolution, 3-D OCT views of coronary anatomy while mapping the exact location of physician’s view via angiogram.

As a result, OPTISTM Integrated System is different from traditional, mobile cart-based diagnostic tools as it provides an advancement of PCI optimization through direct installation into a hospital’s cardiac catheterization laboratory, fully integrating OCT and fractional flow reserve (FFR) into PCI workflow.

Currently, St. Jude Medical carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the medical products industry include ICU Medical, Inc. (ICUI), Abaxis, Inc. (ABAX), and Symmetry Medical, Inc. (SMA). ICU Medical sports a Zacks Rank #1 (Strong Buy), while both Abaxis and Symmetry Medical carry a Zacks Rank #2 (Buy).

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