Press Release FDA clearance for FEMTO LDV Z Models Ziemer Ophthalmic Systems AG Sandro Palumbo, Vice President Marketing (International) Graham Hodge, Managing Director Ziemer USA Inc. +41 32 332 70 52 (International) +1 866 708 4490 (USA) [email protected] (International) [email protected] (USA) www.ziemergroup.com / www.femtoldv.com Company Contact person Phone e-mail Web th Port, Switzerland, March 20 , 2012: Ziemer Ophthalmic Systems AG is pleased to announce that the FDA has granted clearance for the new femtosecond platform, the FEMTO LDV™ Z Models. A few weeks ago, the platform was officially released globally and has already been well received in many countries. FEMTO LDV Z2, Z4 and Z6 – are powerful platforms for performing a broad variety of procedures in ocular surgery. For example, the Z6 model is cleared for the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for the implantation of intra-corneal rings, and pocket creation for the implantation of corneal implants. Z6 can also perform lamellar and penetrating keratoplasties or other treatments requiring lamellar resection of the cornea at varying depths. The Z Model concept defines a strategy that allows for growth with the surgeon’s practice, offering the latest technology available today, on a platform that is ready for tomorrow. Every model is designed for on-site upgrade; modularity makes it happen. Seamless and stepwise upgrades between the different models can be performed at any time. 1 The power of one: A whole range of cornea and presbyopia treatments today, cataract options tomorrow . “We are looking forward to presenting the products and their unique features to the US audience” says Graham Hodge, Managing Director for Ziemer USA Inc. All models are now available for sale in the United States. For further information please visit our dedicated website: www.femtoldv.com or get in contact with Ziemer USA Inc. at 1 866 708 4490. 1 The creation of a corneal pocket is part of a presbyopia intervention. Availability of related corneal inlays and implants depends upon the policies of the individual manufacturers and regulatory status in each country. Cataract procedures with the FEMTO LDV Z2, Z4 and Z6 models are not currently cleared in the United States or in any other country. An upgrade scheme for these devices is planned once cataract capabilities are available and cleared by the responsible regulatory bodies. About Ziemer: Ziemer Ophthalmic Systems AG, a Ziemer Group Company, is a privately held company incorporated in Port, Switzerland. Founded in 1998, Ziemer Group is focused on developing, manufacturing, and marketing leading edge diagnostic and surgical ophthalmic products. Successful products developed by the group include the FEMTO LDV™ and FEMTO LDV™ Crystal Line Femtosecond Surgical Lasers, the AMADEUS® Microkeratome, the PASCAL® Dynamic Contour Tonometer and the GALILEI™ and GALILEI™ G2 Dual Scheimpflug Analyzers. Ziemer USA, Inc. is a fully owned subsidiary of Ziemer Group. It markets all Ziemer Group products in the USA. The FEMTO LDV™ Z Models will be marketed and distributed by Ziemer Ophthalmic Systems AG and its worldwide network of authorized distributors. GALILEI™, FEMTO LDV™ are trademarks, and PASCAL®, AMADEUS® and Z-LASIK® are registered trademarks of Ziemer Group Companies. /1 Ziemer Ophthalmic Systems AG Allmendstrasse 11 / CH-2562 Port, Switzerland www.ziemergroup.com / PHONE: +41 32 332 7050 / FAX: +41 32 332 7071
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