Diabetes: Medtronic wins clearance for next-gen clinical continuous glucose monitor | Regulatory Roundup

November 25, 2011 By MassDevice staff

Medtronic Inc. (NYSE:MDT) won FDA clearance for its next generation iPro2 Professional continuous glucose monitor.

The iPro2 Professional is a clinician-owned device that collects glucose data from a sensor inserted into a patient’s skin.

The device tracks the patient’s glucose levels for 3 days, collecting data as many as 288 times each day. The information may provide insight into how diet, medication and daily activities affect a patient’s glucose levels.

"I find it particularly helpful in identifying repeated glucose lows at night and glucose highs after meals," University Diabetes & Endocrine Consultants’ Dr. David Huffman said in prepared remarks. "I am one doctor in a busy office, but the advances with iPro2 will make Professional CGM accessible to more patients who need it. I see that as better medicine."

Professional CGM is ideal for patients with Type I or Type II diabetes who have are persistently unaware of extreme highs and lows in their glucose levels, according to a published consensus from the American Assn. of Clinical Endocrinologists. The clinician-led process was also recommended for pregnant women and youth with Type I diabetes.

Proper glucose control may help patients avoid complications associated with diabetes, including blindness, kidney failure, amputation, impotence and heart disease, according to a press release.

"CGM adoption is on the rise," Medtronic VP and general manager for the continuous glucose monitoring business Greg Meehan said in prepared remarks. "We believe the combination of improved reimbursement for both clinicians and patients, increased clinical evidence as seen in the Medtronic STAR 3 and JDRF trials, as well as ongoing product advancements, are moving CGM devices toward the standard of care for diabetes management."

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