January 22, 2001
St. Croix Medical WINS FDA APPROVAL TO START CLINICAL TRIALS IN THE UNITED STATES FOR THE ENVOY™ IMPLANTABLE HEARING SYSTEM
Minneapolis-- St. Croix Medical announced today that the FDA approved the Company’s request to begin clinical trials in the United States for their Envoy totally implantable hearing restoration system.
The Company is also conducting clinical trials in Europe for the Conformite Europeane(CE Mark). The CE Mark is a proof of conformity and is currently required for all implantable medical devices.
The Envoy hearing restoration system being developed by St. Croix Medical utilizes technology and components contained in implantable cardiac pacemakers, and other implantable systems to deliver a totally
implantable, biocompatible, small and effective hearing restoration therapy.
Out of more than 60 million people in the industrialized world who have lost hearing, 30 million could use the company's Envoy System, says St. Croix Medical.
The company's Envoy system uses a piezoelectric transducer, or sensor, to detect sound vibrations from the Malleus bone, that is attached to the back of the eardrum.
The system converts those vibrations into electrical signals that are amplified, filtered and then transmitted as mechanical vibrations through another piezoelectric transducer, or driver, to the stapes bone. The Envoy System is considered a Middle Ear Implantable (MEI) System.
The implant operation is nearly identical to middle ear reconstruction and cochlear implant procedures.
St. Croix Medical expects to receive European CE Mark approval first, as it works with the Food and Drug Administration for approval to market in the U.S.
St. Croix Medical believes their technology will significantly improve performance and acceptance over current treatments used for treatment of hearing loss.
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