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FDA OKs Medtronic Activa DBS System for Full-Body MRI Scan

Medical device major Medtronic plc 's MDT Activaportfolio of Deep Brain Stimulation (DBS) neurostimulators' systems recently won the U.S. FDA approval for conditional use in full-body Magnetic Resonance Imaging (MRI) scans. Interestingly, this clearance will benefit an estimated 43,000 people in the U.S. The number is inclusive of those currently receiving Medtronic DBS therapy as well as first-time beneficiaries of the same.

Currently, Medtronic's MR Conditional DBS system is the only approved system to undergo full-body MRI scans. The approval for Medtronic's Activa DBS will help expand the Medtronic DBS-implanted patient population who can now safely undergo MRI scans - an important yet common diagnostic test. The FDA go-ahead will encourage more patients and their physicians to opt for Medtronic's MRI-proof DBS therapy, ramping up the company's profit from this product.

Deep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms, the most common being the debilitating symptoms of Parkinson's disease (PD), such as tremor, rigidity, stiffness, slowed movement, and walking problems. As per 2013 records, MRI scans were performed on 33.8 million U.S. citizens. Notably, 7 out of 10 DBS-eligible patients have a chance of requiring a MRI scan within 10 years of receiving the device.

It is worth noting in this regard that patients with Medtronic's DBS system were allowed to undergo head MRI scans at a low radiofrequency (RF), after their DBS systems were turned off. This was in practice since 2002 following the FDA's approval for the same. However, as stated above, a huge number of patients are constantly in the need of full-body MRI scans, but fail to undergo the same, as per MRI guidelines, when implanted with a DBS system.

The recent FDA approval for the Activa DBS system under full-body MRI scan conditions thus reflects a significant milestone for Medtronic and demonstrates strong potential with respect to the neuromodulation market.

To ensure that its devices are MRI-safe, Medtronic has conducted rigorous tests on its Activa DBS systems and evaluated across 10 million simulated patient scans spanning over 38,000 unique implant conditions to demonstrate patient safety. This reflects management's commitment to deliver innovative and high-quality devices to its customers.

Impressively, in the last reported second quarter of fiscal 2016, Medtronic's neuromodulation division witnessed strong growth in DBS driven by referral development, emerging market expansion and a commercial focus on surgical synergy, which combines Activa DBS implants with its peak surgery system, TYRX Antibacterial Envelope and O-arm imaging.

With the neuromodulation market expected to reach $6.20 billion by 2020, we expect the FDA approval for Medtronic's full-body MRI-safe DBS system to enable the company to capture larger share of this market potential, going ahead.

Currently, Medtronic has a Zacks Rank #3 (Hold). Some better-ranked medical stocks are Natus Medical Inc. BABY , Masimo Corporation MASI and Olympus Corporation OCPNY . All the three stocks hold a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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