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Medtronic Submits Two Pelvic Health Devices for FDA’s PMA


Medtronic plc. MDT has submitted its rechargeable, implantable sacral neuromodulation (SNM) device known as InterStim Micro neurostimulator for the FDA’s pre-market approval (PMA). This PMA supplement filing also includes the company’s InterStim SureScan MRI leads, which will be used together withthe recharge-free InterStim II system and the rechargeable InterStim Micro system for future implants.

The FDA submission for both InterStim products remains crucial the company’s efforts to boost its Pelvic Health & Gastric Therapies business, which falls under Medtronic’s Restorative Therapies Group.

Two InterStim Devices at a Glance

Medtronic’s entire InterStim Therapy for Urinary Control is indicated for the treatment of urinary retention and the symptoms of overactive bladder including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination in patients unable to stand more conservative treatments.

InterStim Micro SNM device is aimed at treating patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention and fecal incontinence. It sends electrical impulses to the sacral nerves, normalizing the connections between the brain, bladder and bowel. This device is 80% smaller than the current recharge-free InterStim II neurostimulator and can reduce the need for battery replacement surgeries due to its durability of 15 years.

Meanwhile, the SureScan leads are designed to provide full-body 1.5 and 3 Tesla MRI conditional labeling. This will allow patients to go for imaging procedures that were not previously indicated under the current FDA approval of the InterStim II system.

Untapped Market Potential

Going by the Market Research Future (MRFR) data published in a Reuters’ article, the global overactive bladder (OAB) treatment market is anticipated to see a CAGR of 3.1% in the assessment period of 2017-2023.

Per a recent data provided by Medtronic, 45% of people suffering OAB don't seek treatment and as many as seven in 10 stop taking medications within six months due to intolerable side effects or unsatisfying results. This clearly indicates enormous market potential that Medtronic can easily tap into if the new devices get FDA nods.

Price Performance

In the past three months, shares of the company have outperformed the industry. The stock has rallied 6.7% against the industry’s 2.4% fall.

Zacks Rank and Other Stocks Worth a Look

Medtronic carries a Zacks Rank #2 (Buy). A few other top-ranked stocks in the broader medical space are Stryker SYK, NuVasive NUVA and Amedisys AMED, each carrying a Zacks Rank of 2.You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Stryker’s long-term earnings growth rate is expected to be 10.04%.

NuVasive’s long-term earnings growth rate is projected at 7.32%.

Amedisys’ long-term earnings growth rate is estimated to be 16.26%.

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