Medtronic's Guardian Sensor 3 With MiniMed 670G Wins FDA Nod
Zacks Investment Research | Mar 01, 2018 11:47PM ET
Medtronic plc (NYSE:MDT) announced that the FDA has approved a new arm indication for the Guardian Sensor 3 continuous glucose monitor (CGM) used with the MiniMed 670G insulin pump. Notably, the Guardian Sensor 3 is the company’s latest and most accurate CGM. Per Medtronic, this is the only sensor to have received an FDA nod for controlling automated insulin delivery via a hybrid closed loop system, the MiniMed 670G.
It is important to note that Medtronic commercially launched the MiniMed 670G system in June 2017. The system is a Hybrid Closed Loop insulin delivery system for Type I diabetic patients aged 14 years or older.
The MiniMed 670G system features Medtronic’s Guardian Sensor 3, a glucose sensor with increased accuracy and enhanced performance.
This new arm indication for the Guardian Sensor 3 now offers more convenience and flexibility for patients. It is available in the United States for use with the MiniMed 670G system.
Progress in MiniMed Portfolio
Medtronic has been forging ahead with initiatives to boost the performance of its MiniMed portfolio. Recently, the company expanded its product portfolio with the unveiling of MiniMed Mio Advance infusion set. The recent offering from the Diabetes business will be commercially available in Canada, Hong Kong and certain countries across Europe in fourth-quarter fiscal 2018. However, the company plans an extensive launch of the same in 2018.
Also, the company reported positive data from an at-home pediatric study on patients aged between seven and 13 years. The outcome is based on MiniMed 670G system and was demonstrated at the Advanced Technologies & Treatments for Diabetes’ 11th International Conference in Vienna, Austria.
Developments in Diabetes Business
Medtronic witnessed a 13% rise at constant exchange rate in the Diabetes business revenues during third-quarter fiscal 2018. The company benefited from a positive uptake of new sensor-augmented insulin pump systems in the United States as well as in the international markets along with enhanced production capacity for the same.
Notably, Medtronic expects double-digit growth in the segment in fourth-quarter fiscal 2018, courtesy of a consistent performance of MiniMed 670G system in the United States along with enhanced sensor supply capacity.
Additionally, Medtronic has been gearing up for the international introduction of the MiniMed 670G and the U.S. launch of CGM system Guardian Connect with sugar IQ in late 2018 and its new professional CGM iPro 3 in 2019. In this regard, the company had earlier announced favorable results supporting the use of CGM on patients with type 2 diabetes in October 2017.
Market Potential
An ageing population, unhealthy lifestyle, a rising awareness as well as expenditure in healthcare are likely to drive growth in the diabetes market. Per a report by Mordor Intelligence, the global market for diabetes care devices is projected to reach a value of $30.25 billion by 2021 at a CAGR of 5.93%. Considering the bullish market sentiments, we believe the latest development has arrived at an opportune moment.
Stock Performance & Estimate Revision
Over the last three months, shares of Medtronic have underperformed the Zacks Investment Research
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