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News Breaks
December 21, 2012
14:46 EDTMDTFDA posts recall of Medtronic drug infusion pump
The FDA today posted on its website the November 9 recall of Medtronic's SynchroMed II and SynchroMed EL implantable drug infusion pumps. "The use of unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion," the FDA said. Reference Link
News For MDT From The Last 14 Days
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April 30, 2015
09:22 EDTMDTMedtronic initiates study of AF treatment with ablation procedures combination
Medtronic announced the start of a clinical study using Medtronic technologies to determine whether paroxysmal and persistent atrial fibrillation, or AF, can be treated with a combination of two ablation procedures targeting different anatomical locations - specifically, the pulmonary veins and the renal arteries. Study patients will also receive an implantable cardiac monitor to track their heart rhythm on an automatic and continuous basis. Patients in both arms of the trial also will receive a Reveal LINQ Insertable Cardiac Monitor to automatically and continuously detect and record the net recurrence of abnormal heart rhythms after therapy randomization. This more comprehensive method of cardiac monitoring will provide greater detail and accuracy about the treatment effect of combination therapy with PVI and renal denervation versus PVI alone. SYMPLICITY AF will enroll up to 245 patients in up to 12 centers throughout the United States. Seventy of these patients meeting all inclusion but no exclusion criteria and thus determined to be eligible for the trial will then be randomized to either PVI and RDN or PVI alone; all randomized subjects will receive a Reveal LINQ ICM. The primary safety endpoint is comprised of events related to both the PVI and RDN procedures. The primary efficacy endpoint will measure freedom of chronic treatment failure, defined as AF lasting 30 seconds or longer or the requirement for an intervention for atrial fibrillation through a minimum of six months. Heart rhythm data from the Reveal LINQ ICM will be reviewed monthly.
April 29, 2015
06:49 EDTMDTMedtronic's stent graft system shows positive results
Medtronic's Endurant AAA stent graft system delivered positive results for endovascular repair of abdominal aortic aneurysmsin patients with short and standard neck lengths who were enrolled in the global ENGAGE registry. Delivery and deployment was successful in 99.4% of the patients with a standard neck and in 100% of the patients with a short neck. Through four years, the two groups showed similar results in terms of secondary endovascular procedures, ruptures or conversions to open repair, and no main body migrations were reported in any of the patients.
April 27, 2015
15:35 EDTMDTMedtronic announces consent decree with FDA for Synchromed system
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15:31 EDTMDTFDA enters consent decree with Medtronic
The FDA announced the filing of a consent decree against Medtronic and two of the company’s officers—S. Omar Ishrak and Thomas Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. These violations occurred at the company’s Neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufactured. The legal action requires the company to stop manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump Systems except in very limited cases, such as when a physician determines that the Synchromed II Implantable Infusion Pump System is medically necessary for a patient’s treatment. The consent decree also requires Medtronic to retain a third-party expert to help develop and submit plans to the FDA to correct violations. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree.
11:02 EDTMDTMedtronic begins clinical study of Endurant Evo AAA strent graft system
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April 21, 2015
11:02 EDTMDTMedtronic begins enrollment in feasibility study of Valiant Mona LSA system
Medtronic announced the start of a new feasibility study to evaluate the safety and effectiveness of the Valiant Mona LSA branch thoracic stent graft system, an investigational medical device designed to enable a completely endovascular solution for aortic aneurysms encroaching on the left subclavian artery. Cleveland Clinic cardiothoracic surgeon Dr. Eric Roselli successfully completed the first implant in the study on Thursday. He serves as the study's national primary investigator and receives consulting fees and honoraria for teaching from Medtronic. The study aims to enroll 24 subjects at up to seven sites in the United States. The purpose of the study is to characterize the safety and effectiveness of the investigational device acutely and at 30 days.

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