Medtronic, Inc. announced CE Mark approval and the first global use and launch of the Medtronic CoreValve® delivery system with AccuTrak™ Stability Layer for transcatheter aortic valve implantation (TAVI). AccuTrak’s proprietary technology allows physicians to achieve enhanced control and accuracy in the deployment of the CoreValv device. CoreValve and AccuTrak are not yet available in the United States, Canada or Japan for investigational or commercial sale or use.

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Medtronic, Inc. has announced European launch of the Protecta™ portfolio of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds). The implantable defibrillators feature Medtronic-exclusive SmartShock™ Technology, comprised of six advanced shock-reduction algorithms that can significantly reduce inappropriate shocks. Findings from the Virtual ICD study statistical model predicted 98 percent of studied patients with SmartShock Technology would be free of inappropriate shocks one year after implant and 92 percent at five years post-implant.

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Medtronic, Inc. has announced the launch of iPro™2 Professional CGM, a continuous glucose monitoring (CGM) system used by physicians to help improve diabetes management, in 49 countries around the world. This simplified, yet more advanced fourth-generation CGM system is valuable for detecting high and low glucose fluctuations that can lead to dangerous health complications, which often go undetected with traditional A1C tests and glucose meter measurements.

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Medtronic, Inc.’s Discyphor Direct™ Catheter System is now available in United States. Doctors use the second-generation catheter system to get more information on detecting the disc that causes discogenic low back pain. The system uses the company’s innovative Functional Anaesthetic Discography™ Procedure. Each disc is anesthetized individually for diagnosis of the disc that causes pain. Spine surgeons often use the procedure’s benefit in the form of diagnostic results to determine the best treatment for patients.

The Supreme Court has ruled in favor of medical device manufacturers, making it more difficult for consumers to sue the makers of devices that have been federally approved. The court ruled 8-to-1 in favor of Medtronic in a lawsuit filed against the company by Mrs. Charles Riegel. The lawsuit said that a balloon catheter had burst while Mr. Riegel was undergoing an angioplasty. The Supreme Court upheld a federal district court’s decision, dismissing the lawsuit on the ground that the catheter had been given pre-market approval by the FDA.

Medtronic Inc. has received FDA approval for RestoreULTRA, an implantable neurostimulation system device for the treatment of chronic, troublesome pain in the back and leg. Patients can adjust the stimulations produced by the rechargeable device according to fluctuations in pain through a remote control, apart from directing the stimulations at a specific point in the spinal cord. The company plans to make the device available in the U.S. by the end of February.

Medtronic Inc. has received FDA approval for its CGMS iPro Recorder, a new physician use continuous glucose monitoring system. The CGMS iPro Recorder records the glucose pattern in a patient, who is advised to wear it for three days. The data is then reviewed by physicians to uncover glucose patterns in the patient and optimize therapy. The device is reimbursable by Medicare.