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January 31, 2012

Merit Medical Purchases Assets of Ostial Solutions

February 1, 2012—Merit Medical Systems, Inc. (South Jordan, UT) announced that it has acquired the assets of Ostial Solutions, LLC (Kalamazoo, MI).

According to Merit Medical, the primary asset of Ostial Solutions is the Ostial Pro Stent Positioning System, which facilitates precise stent implantation in coronary and renal aorto-ostial lesions when deploying a stent at the “true” ostium of the vessel. The device is compatible with 6-, 7-, and 8-F guiding catheters and any manufacturer's stent platforms. The anticipated benefits of this system would be to minimize the risk of the stent being deployed too proximal or too distal to the ostium, reducing the need for a second stent, as well as decreasing overall procedure time.

Merit Medical stated that the device received 510(k) clearance from the US Food and Drug Administration and that the company has commenced shipment of the product from its facilities.

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February 1, 2012

FDA and Industry Reach Agreement in Principle on Medical Device User Fees

February 1, 2012

FDA and Industry Reach Agreement in Principle on Medical Device User Fees