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FDA Classifies Previously Announced Medtronic Physician Advisory On Small Subset Of Kappa And Sigma Pacemakers As Class I Recall

Medtronic, Inc. (NYSE: MDT) announced the U.S. Food and Drug Administration (FDA) has classified Medtronic"s previously announced physician advisory about a small subset of Kappa® and Sigma® series pacemakers, identified at increased susceptibility for separation of bonded interconnect wires from the electronic circuit, as a Class I recall. Notification to U.S. FDA, physicians and patients began May 18, 2009. As of the date of this news release, more than 95 percent of physicians following affected devices in the United States have confirmed receipt of the notification. The FDA"s classification of Medtronic"s Important Patient Safety Information does not alter the patient management recommendations already provided in the May 2009 letter, and physicians need not take any new action.
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Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) For The Treatment Of Fabry Disease

Amicus Therapeutics (Nasdaq: FOLD) announced it has commenced the U.S. registration Phase 3 trial with its investigational drug, Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease. The Company has reached agreement with the U.S. Food and Drug Administration (FDA) on the key protocol design elements of the pivotal trial, including the use of the surrogate primary endpoint of the change in the amount of kidney interstitial capillary GL-3, the substrate that accumulates in the cells of Fabry patients. In addition, the FDA is in agreement that the Company is eligible to seek Accelerated Approval for Amigal according to Subpart H regulations. The Company has begun submitting the Phase 3 protocol to investigational sites worldwide and expects to begin the dosing of subjects in the second half of this year.