Medtronic Inc. said Wednesday that it has resolved two warning letters from the Food and Drug Administration, news that could clear the way for the company to launch several products in the United States.
FDA lifts restrictions on Medtronic
The move means several new products may be launched soon now that the regulator's procedural questions have been resolved.
March 10, 2011 at 3:39AM
The federal regulatory agency in 2009 questioned manufacturing and recordkeeping procedures at Medtronic facilities in Mounds View and in Juncos, Puerto Rico, that involve production of heart defibrillators, pacemakers, pain and insulin pumps and other products.
Until issues cited in the warning letters were resolved, Fridley-based Medtronic was largely prevented from launching new products in the United States that were made at the facilities.
Medtronic is anticipating FDA approval of its Protecta heart defibrillator, which minimizes inappropriate shocks in patients. Stopwatch-sized defibrillators are implanted in the chest and engineered to shock the heart if an irregular rhythm is detected. However, sometimes the device may shock a patient when it is not needed, an uncomfortable and traumatic event.
Another widely anticipated new device is Medtronic's InterStim therapy, for fecal incontinence. The pacemaker-like device delivers tiny electrical pulses to the sacral nerve to stimulate the nerves and muscles that control bowel movements. The technology already is approved to treat patients with urinary incontinence and retention issues, has been available in markets outside the United States since 2000 for fecal incontinence.
According to the National Institutes of Health, more than 5.5 million Americans have the condition, which is more common in women and adults. One analyst said the overall market for the Interstim device could be up to $300 million.
Although an FDA advisory panel has recommended approval of the products, it's unclear if and when actual approvals will happen.
Medtronic, the nation's largest medical-device company, could use a boost. In the most recent fiscal quarter, the company reported continued softness in sales of its heart rhythm and spine surgery products because of a sluggish economy and pricing pressure as hospitals cut costs, particularly for defibrillators.
Tao Levy, an analyst with Collins Stewart, said in a note Wednesday that he expects the Protecta defibrillator to be launched at a premium price "which will further stabilize the pricing environment for [defibrillators]." The news Wednesday means "a major hurdle has been removed."
Medtronic shares closed Wednesday at $39.80, up 16 cents.
Janet Moore • 612-673-7752
Pulse oximeters helped drive racial inequities in care during the pandemic, but many devices at drugstores and online won’t be subject to the guidelines.
