FDA Nod for Medtronic's iPro2 - Analyst Blog
November 25 2011 - 9:45AM
Zacks
Leading medical devices player,
Medtronic (MDT) has received approval from the US
Food and Drug Administration (FDA) for iPro2, a next generation
Professional continuous glucose monitoring (CGM) system. This
product would better equip healthcare providers to assess the
status of glucose control for the patients they treat. They will
also be able to judge how diet, medication, and daily activities
affect their patients’ glucose levels.
Approval of iPro2 is significant as
professional CGM is used by healthcare providers to reveal low
(hypoglycemia) and high (hyperglycemia) glucose excursions that can
worsen the condition of diabetic patients. These excursions
often go unnoticed with traditional A1C tests and standard glucose
meter measurements.
The American Association of
Clinical Endocrinologists (AACE) and the Endocrine Society have
both recommended the use of Professional CGM on a broad range of
diabetic patients. They are of the opinion that Professional
CGM is ideal for type 1 or type 2 diabetes patients who are not
achieving target A1C levels, and for patients who have recurrent
hypoglycemia or hypoglycemia unawareness.
The last few quarters saw Medtronic
reporting weaker sales from its two largest segments –
defibrillators and spinal implants. The US ICD market has been
affected by a number of challenges, namely the adverse article in
the Journal of the American Medical Association published in
January 2011 and the Department of Justice investigation of
hospitals. The challenges witnessed in the US ICD market have also
been felt across the board and impacted Medtronic’s competitors,
Boston Scientific (BSX) and St Jude
Medical (STJ).
To overcome these challenges,
Medtronic is trying every means to revive growth. This includes
penetration of international markets, portfolio expansion, focus on
segments bearing potential and restructuring initiatives, which
should benefit the company over the long term.
The Diabetes segment, in this case,
has been a point of focus for the company and has been recording
robust growth over the recent past. During the most recent quarter,
this segment recorded $367 million in sales, up 13% year over year
(10% at constant exchange rate or CER) driven by double-digit
growth in insulin pumps and CGM. Moreover, Medtronic recorded 15%
growth in Diabetes revenue derived from the international market
with greater adoption of Veo pump and Enlite Sensor.
We currently have a Neutral
recommendation on Medtronic, which also corresponds to the Zacks #3
Rank (Hold) in the short term.
BOSTON SCIENTIF (BSX): Free Stock Analysis Report
MEDTRONIC (MDT): Free Stock Analysis Report
ST JUDE MEDICAL (STJ): Free Stock Analysis Report
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