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STAAR Surgical Receives FDA Approval for AquaFlow(TM)

  • 2001-07-16
  • Press release

MONROVIA, Calif., July 16 /PRNewswire/ -- STAAR Surgical Company (Nasdaq: STAA) announced today that it has received Pre-Market Approval (PMA) from the United States Food and Drug Administration (FDA) for its AquaFlow(TM) Collagen Glaucoma Drainage Device for use in the correction of open-angle Glaucoma. The Company is prepared to begin shipment of the device immediately. The AquaFlow has been approved and marketed in other countries for several years. In 1997, AquaFlow received CE Mark allowing it to be marketed throughout the European Union. Earlier this year a Medical Device Licensure was received from Health Canada, allowing the marketing of AquaFlow throughout Canada.

According to David Bailey, president and chairman of STAAR Surgical Company, "We have made a significant investment to prepare for marketing of the AquaFlow upon FDA approval. We have trained over 300 physicians who are now ready to use the AquaFlow and shipments will begin immediately. FDA approval of the AquaFlow is a major milestone for STAAR Surgical as it opens a potential market in the U.S. of approximately $70 million."

Stephen Bylsma, M.D. of the Shepard Eye Center in Santa Maria, California who is the medical monitor for the AquaFlow said, "While the traditional trabeculectomy (glaucoma surgery) is very effective, the potential risks are not trivial. With the AquaFlow procedure, we have an effective way to lower intraocular pressure with much lower risks than standard trabeculectomy. This means a quicker return to normal activities for the patient and fewer visits and post-operative procedures for both patient and doctor."

Bylsma added, "I have been impressed by the consistent results of the AquaFlow procedure, with patients returning to normal activities much faster than with traditional glaucoma surgery. Most patients have a good lowering of intraocular pressure and remain without the need for eye drops to control their pressure."

STAAR's AquaFlow Collagen Glaucoma Drainage Device is implanted as part of a lower risk, non-penetrating surgical procedure for the treatment of glaucoma that helps to significantly reduce pressure in the eye. AquaFlow study patients had very few of the complications often associated with traditional glaucoma surgery. In most cases the AquaFlow surgery eliminates the need for glaucoma medications. Glaucoma is often associated with increased intraocular pressure. Left untreated, this increased pressure can damage the optic nerve resulting in a gradual decline in vision, blind spots and eventual blindness. Affecting roughly 67 million people worldwide, glaucoma is a leading cause of blindness if left untreated. In the U.S., there are an estimated 4 million people afflicted with approximately 100,000 new cases diagnosed each year. The worldwide glaucoma drug market is about $1.4 billion.

Founded in 1982, STAAR Surgical Company develops, manufactures and globally distributes medical devices for use in refractive, cataract and glaucoma surgery. The Company's five product lines include silicone and Collamer(TM) foldable intraocular lenses and the Sonic WAVE(TM) phacoemulsification system, all of which are used during cataract surgery, the ICL(TM) (implantable contact lens) which is a refractive lens for the treatment of near- and far-sightedness and the AquaFlow(TM) Collagen Glaucoma Drainage Device. Regulatory approvals vary from market to market with all products except the Toric ICL(TM) and the 3-piece Collamer(TM) IOL available in Europe and all except the ICL(TM) in the United States.

For additional information, about STAAR Surgical, visit the Company's web site at or . You may wish to contact David Bailey, President, STAAR Surgical, or John Santos, Chief Financial Officer, STAAR Surgical, at (626) 303-7902. To contact Bill Roberts, President, CTC, Inc., or Ellen Geron, CTC Inc., please call (937) 434-2700

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SOURCE STAAR Surgical Company

CONTACT: David Bailey, President, or John Santos, Chief Financial Officer, both of STAAR Surgical, +1-626-303-7902; or Bill Roberts, President or Ellen Geron of CTC Inc., +1-937-434-2700/