Citing a recent U.S. Supreme Court decision, a federal judge in St. Paul on Monday dismissed dozens of lawsuits filed by patients who claimed they were injured by a heart device made by Medtronic Inc.
The patients were implanted with an electrical lead used in a defibrillator system known as Sprint Fidelis made by the Fridley-based medical technology company.
In October 2007, Medtronic’s popular Sprint Fidelis lead was recalled by the Food and Read the rest of this entry »

–
RESOLUTE All-Comers — This trial will
randomize approximately 2,300 patients, in a one-to-one manner, to the
Endeavor Resolute or Abbott Laboratories’
Xience(R) DES at 15–20
international medical centers in countries where both stents are
commercially available. Patients seen in routine clinical practice are
eligible for enrollment — the meaning of “All-Comers.”
The Read the rest of this entry »

(NYSE: MDT) on Thursday announced its official entrance into the psychiatric therapies field, with federal regulators approving an implanted device meant to treat severe obsessive-compulsive disorder.
Fridley-based Medtronic’s Reclaim Deep Brain Stimulation Therapy is a small pacemaker-like device that delivers electric charges to the brain.
The U.S. Food and Drug Administration approved the device under a “humanitarian device exemption.” Read the rest of this entry »

-(Dow Jones)- The Food and Drug Administration Thursday approved
the first implantable device designed to deliver electrical therapy to the brain
to suppress symptoms associated with severe obsessive-compulsive disorder.
The device, known as Reclaim DBS [deep brain stimulation] Therapy, is made by
Medtronic Inc.
(MDT). The product was approved to treat patients with OCD in
cases where drug and psychotherapy have failed. It’s expected the device Read the rest of this entry »

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MADISON, Wis.
– Patients cannot sue the makers of potentially unsafe medical devices approved for sale by federal regulators, the Wisconsin Supreme Court ruled Tuesday.
The court ruled against a Wisconsin man who had surgery to remove a defibrillator after the manufacturer, Medtronic, Inc., warned its battery had a chance of failing. The ruling is a victory for Minneapolis-based Medtronic and other manufacturers who want to limit product liability.
Read the rest of this entry »

Citing a recent U.S. Supreme Court decision, a federal judge in St. Paul on Monday dismissed dozens of lawsuits filed by patients who claimed they were injured by a heart device made by Medtronic Inc.
The patients were implanted with an electrical lead used in a defibrillator system known as Sprint Fidelis made by the Fridley-based medical technology company.
In October 2007, Medtronic’s popular Sprint Fidelis lead was recalled by the Food and Read the rest of this entry »

Monday, December 15, 2008
,
is reporting that its deep brain stimulation device, the Intercept™ Epilepsy Control System, has been shown to “significantly reduced seizure frequency among patients with medically refractory epilepsy with partial-onset seizures.” According to a brief statement on the firm’s website, Medtronic will be seeking a premarket regulatory approval from the FDA for this system. We are guessing that the indication for Read the rest of this entry »

Inc. said it was unaware for more than three months that a patient who underwent spinal surgery with one of its products had died, and the company is now moving to report the death to the Food and Drug Administration.
In August, Medtronic reported to the FDA that the patient, Shirley Nisbet, was having trouble breathing and fell into a coma four days after a spinal-fusion surgery that used a Medtronic implant for promoting bone growth. The company Read the rest of this entry »

The Department of Justice is investigating the off-label use of a Medtronic Inc. implant for promoting bone growth, bringing government scrutiny of such unapproved uses to the heart of the $189 billion medical-device industry.
The probe — in combination with a government safety warning and whistleblowers’ lawsuits — has created what Medtronic Chief Executive William A. Hawkins termed Tuesday a “perfect storm” that suppressed sales of Infuse Bone Read the rest of this entry »