Medtronic Initiates Enrollment for Pivotal Diabetes IDE Study

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Renowned medical technology giant Medtronic Inc. (MDT) has enrolled the first set of patients for a pivotal study of the first Predictive Low Glucose Management (PLGM) technology for people with diabetes.

The pivotal study is an investigational device exemption (IDE) research of Medtronic's revolutionary PLGM diabetes-control technology. The commencement of this study marks a crucial step toward the evolution of an artificial pancreas in the U.S. market.

Following this news release, Medtronic's share price inched up 0.7% immediately, but eventually dropped 2% to close at $62.25 yesterday.

PLGM's Role in Diabetes Control

The PLGM technology has been designed to help diabetes patients better manage hypoglycemia safely without causing a rebound hyperglycemic episode, which is often associated with external insulin therapy use.

The PLGM technology incorporates Medtronic's currently accessible Threshold Suspend feature. This Threshold Suspend refers to a diabetes management tool that is currently only available in the U.S. and has the ability to automatically stop insulin delivery once sensor glucose values reach a preset low level.

A Brief Note on the Study

Per the announcement, the IDE trial aims at estimating the safety of Medtronic's next-generation integrated insulin pump and continuous glucose monitoring (CGM) system. This CGM system has the same features as the Threshold Suspend system.

Medtronic will enroll up to 84 patients at 8 investigational centers in the U.S. to evaluate the efficacy of the PLGM system.

Financial Impact

Diabetes has become a major healthcare concern, with its prevalence increasing at an alarming rate around the world. Medtronic aims at better diabetes care by expanding access to improved treatment options and advancing its CGM system. In the last reported quarter, Medtronic had achieved double-digit revenue growth in its diabetes segment buoyed by the strong U.S. performance of its freshly launched MiniMed 530G with Enlite CGM sensor.

We may reasonably expect once the IDE trial results are out, Medtronic's market share will expand bringing in more profits at the company. Moreover, per reliable resources, this IDE study will equip the entire healthcare industry with an advanced tool for better glycemic management.

Zacks Rank

Currently, Medtronic carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical products industry include ZELTIQ Aesthetics, Inc. (ZLTQ), Abaxis, Inc. (ABAX) and Alere Inc. (ALR). While ZELTIQ Aesthetics sports a Zacks Rank #1 (Strong Buy), Abaxis and Alere hold a Zacks Rank #2 (Buy).

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