Medtronic Inc. (NYSE:MDT) won a supplemental PMA from the Food & Drug Administration for the latest version of its MiniMed Paradigm REAL-Time diabetes management system, which it touts as the “industry’s only integrated diabetes management system.”
And the Fridley, Minn.-based medical devices monolith put another product into the PMA pipeline, its Arctic Front cryoablation catheter system, after revealing positive study results at a recent conference.
Revel diabetes management system wins PMA
Minimed’s new Revel model incorporates continuous glucose monitoring designed to alert patients when their blood sugar levels get too high or too low. The alerts can be customized to account for patients exercising or to manage nocturnal hypoglycemia. The system also includes diabetes therapy management software.
Katie Szyman, president of Medtronics’ diabetes division, said in prepared remarks that the product is a step "in the path towards the artificial pancreas."
A Medtronic spokeswoman told MassDevice the company received a letter from the FDA March 16, granting a supplemental PMA based on prior models of the MiniMed Paradigm REAL-Time system.
The federal watchdog will likely pay close attention to how the system fares, as part of its closer scrutiny of insulin pump safety. Earlier this month the FDA convened a panel to examine the risks posed by the devices, after 18 recalls were issued over five years and reports of 17,000 adverse events — including 310 deaths and 12,000 injuries — between 2006 and 2008. The agency says that more than 375,000 people in the U.S. use an insulin pump to treat their Type I diabetes, up some 188 percent from the 130,000 people reported to use the devices in 2002.
Arctic Front PMA application follows positive study results
Medtronic also announced the completion of its PMA submission for the Arctic Front cardiac cryoablation catheter system, designed to treat paroxysmal atrial fibrillation. The move came hard on the heels of the release of positive results from a clinical trial of the device at the American College of Cardiology’s 59th annual scientific session in Atlanta.
The system uses freezing temperatures to kill the muscle cells causing a portion of the heart wall to flutter. The Stop AF
trial showed that, one year out, nearly 70 percent of the roughly 163 patients treated with the cryoablation procedure stayed free of PAF, compared with 7.3 percent of patients treated using drugs.