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First LASIK With the Advanced IntraLase Method(TM) Performed on U.S. Naval Aviator

IRVINE, Calif., Dec. 11 /PRNewswire-FirstCall/ -- Marking both a milestone in U.S. Naval medicine and refractive surgery, IntraLase(R) Corp. today confirmed the Navy's announcement that the first LASIK procedure using the IntraLase (Nachrichten) Method has been performed on an aviator as part of a new Bureau of Naval Medicine project (http://www-nmcsd.med.navy.mil/news/news_view.cfm?nrid=258). Currently, LASIK is not approved for use in the U.S. military aviation community. But, after many years of intense LASIK clinical trials on non-aviation personnel, the new Bureau of Naval Medicine project is underway to treat four additional aviators with LASIK using the IntraLase Method scheduled as part of the first step of the program.

Though LASIK has been around for many years, concerns about the harsh aviation environment prevented its use in U.S. Navy aviators. Aeromedical professionals have been cautious of employing the procedure on aviators who frequently encounter environmental extremes such as high altitude, dry air, wind blast and 'G' forces.

According to Capt. Steve Schallhorn, Navy Program Manager for Refractive Surgery, "While LASIK has been around for many years and is a common elective procedure, this is a significant first in the aeromedical field. Wavefront guided LASIK using the IntraLase Method represents the best-of-the-best and is a truly exciting advancement for critical Navy personnel whose sight is of utmost importance in their military duties."

The IntraLase FS laser is the first technology for a truly all-laser, blade-free LASIK procedure, replacing the hand-held microkeratome blade historically used in creating LASIK corneal flaps -- the first step of the procedure -- with a computer-guided, ultra-fast femtosecond (fem-to-second) laser. The IntraLase laser virtually eliminates almost all of the most severe, sight-threatening LASIK complications related to use of the microkeratome and, by creating an optimal corneal surface below the flap, provides for better visual outcomes -- taking many patients to 20/20 vision and beyond.

While LASIK remains the most popular surgery in the civilian community, the Naval Medical Center San Diego's Refractive Surgery Center is the only center currently in Department of Defense offering LASIK using the IntraLase Method.

The first candidate was aviator, Marine Capt. Michael Oginsky, an FA 18/D weapons and sensor officer with VMFAT 101 at U.S. Marine Corps Air Station Miramar. Within just four hours, Oginsky's vision was 20/20. At the 24-hour mark, his vision exceeded 20/20. There are four additional aviators scheduled to take part in the first step of the program and have LASIK using the IntraLase Method performed.

More than 1,200 surgeons worldwide have incorporated the blade-free IntraLase Method into their LASIK practices. In fact, the majority of the top U.S. ophthalmic teaching institutes including Duke University Medical School, the Wilmer Eye Institute at Johns Hopkins, the Bascom Palmer Eye Institute at University of Miami, and Stanford University use the IntraLase FS laser technology to train future generations of LASIK surgeons.

LASIK using the Advanced IntraLase Method

The 4th Generation IntraLase FS laser uses an infrared light beam, generating 60,000 pulses per second, to prepare the intracorneal bed and create the corneal flap in the first step of LASIK.

• Using an "inside-out" process, the laser beam is precisely focused to a point within the cornea.
• The laser pulses then create thousands of microscopic bubbles which define the incision within the intracorneal surface.
• Along the edge, bubbles are then stacked up at a beveled angle -- a feature unique to the IntraLase Method -- to the corneal surface to complete the flap.
• From start to finish, the IntraLase Method typically takes 15 - 30 seconds. * The physician then exposes the prepared corneal bed for excimer laser treatment (the second step of LASIK) by lifting the flap.
• The LASIK procedure is complete when the flap is securely repositioned on its beveled edge.

With the IntraLase laser, the surgeon can precisely control the critical first step of LASIK. Physician-programmed laser specifications include flap diameter, depth, hinge location and width, and side-cut architecture -- factors which can be varied to meet patients' needs. The IntraLase laser creates a distinctive beveled-edge flap, which allows for precise repositioning, alignment and seating after the LASIK procedure is completed. This feature helps reduce the risk of flap displacement, a complication seen with microkeratome flaps.

Blade-Free Safety and Better Vision with All-Laser LASIK

The IntraLase laser makes LASIK safer by replacing the hand-held microkeratome blade with the computer-guided precision of a laser, virtually eliminating almost all the most severe, sight-threatening blade-related LASIK complications as a result. Leading LASIK surgeons have reported on data of the IntraLase Method procedures, which demonstrate an impressive safety profile.

Beyond improving the safety of the procedure, LASIK using the advanced IntraLase Method has been shown clinically to deliver better visual outcomes in both standard and Custom LASIK procedures with more patients achieving visual acuity of 20/20, 20/15 and even 20/12.5. These remarkable results are the product of the optimized corneal surface prepared by the IntraLase FS laser in creating the corneal flap. The precision of the laser reduces the microscopic inconsistencies on the corneal bed, providing an optimal surface for the vision correction performed by the excimer laser in step two of the LASIK procedure.

About IntraLase Corp.

IntraLase designs, develops, and manufactures an ultra-fast laser that is revolutionizing refractive and corneal surgery by creating safe and more precise corneal incisions. Delivering on the promise of ophthalmic laser technology, the IntraLase FS laser, related software, and disposable devices replace the hand-held microkeratome blade used during LASIK surgery. The unsurpassed accuracy of IntraLase's computer-controlled femtosecond laser has been shown to improve safety profiles and visual outcomes when used during LASIK. Additionally, the IntraLase FS laser creates precision-designed intracorneal incisions that when combined can be used during lamellar and penetrating keratoplasty, and intrastromal ring implantation. IntraLase is presently in the process of commercializing applications of its technology in the treatment of corneal diseases that require corneal transplant surgery. The company's proprietary laser and disposable patient interfaces are presently marketed throughout the United States and 32 other countries. IntraLase is headquartered and manufactures its products in Irvine, California. For additional information, visit the company's web site: http://www.intralase.com/.

Forward Looking Statements

Statements contained in this press release that are not historical information are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "anticipate," "intend," "plan," "estimate," "project," or words of similar meaning, or future or conditional verbs such as "will," "would," "should," "could," or "may." Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied. Those risks and uncertainties include, but are not limited to: the degree of continued acceptance of LASIK surgery; potential complications revealed by long-term follow up; the extent of adoption of our product offering by LASIK surgeons; general economic conditions; changes in federal tax laws governing the ability of potential LASIK patients to use pre-tax dollars to pay for LASIK surgery; the scope of government regulation applicable to our products; patients' willingness to pay for LASIK surgery; our ability to compete against our competitors; the effectiveness of our measures to ensure full payment of procedure fees; the occurrence and outcome of product liability suits against us; our ability to adequately protect our intellectual property; whether we become subject to claims of infringement or misappropriation of the intellectual property rights of others; the continued availability of supplies from single-source suppliers and manufacturers of our key laser components; the ability of our managers, operations, and facilities to manage our growth; the success of our expansion into markets outside the United States; whether we lose any of our key executives or fail to attract qualified personnel; or if our new products or applications fail to become commercially viable.

Certain of these risks and uncertainties, in addition to other risks, are more fully described in the company's quarterly report on Form 10-Q for the period ending September 30, 2006, as filed with the Securities and Exchange Commission on October 31, 2006.

These forward-looking statements are made only as of the date of this press release, and the company assumes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events, or otherwise.

 

Navy Medicine Takes First Step With LASIK for Aviators

CAPT Steve Schallhorn Director of the Navy Refractive Surgery Center performs LASIK refractive surgery on Marine Capt Michael Oginsky, USMC. Oginsky is the first Naval Aviator to undergo this type of surgery which previously was unavailable to aviators. (Photo courtesy of LCDR Tyson Brunstedder)

Corrective eye surgery has taken a big step into the final frontier of Naval Aviation, Nov. 8.  For the first time, as part of a new program, the vision correction surgery LASIK has been performed on an aviator.

Previously, aviators have been ineligible for this surgery.

According to Capt Steve Schallhorn, Navy Program Manager for Refractive Surgery, Laser In Situ Keratomileusis, or LASIK, is not currently approved for use in the aviation community.  However a new Bureau of Naval Medicine project is underway after many years of intense clinical trials on non-aviation personnel.

Another milestone of the procedure is wavefront guided LASIK (CustomVue) in combination with a femtosecond laser (Intralase) to create the flap.  This combination represents the "best of the best" according to Dr. Schallhorn.

Though this procedure is becoming more common in the community, NMCSD's Refractive Surgery Center is the only center currently in DoD to offer the combination.  This should change soon as the Intralase becomes available to other Navy refractive surgery centers.

In all, Schallhorn completed the 20 minute procedure though the actual laser surgery took approximately 25 seconds.

"This procedure on an aviator is a milestone for refractive surgery, both for the military and the community in general," said Schallhorn.

The first candidate was Marine Capt. Michael Oginsky, an FA 18/D weapons and sensor officer with VMFAT 101 at Marine Corps Air Station Miramar.

There are four additional aviators scheduled to take part in the first step of the program.

Though LASIK has been around for many years, concerns about the harsh aviation environment have prevented its use.  Aeromedical professionals have been cautious of employing the procedure on patients who frequently encounter environmental extremes such as high altitude, dry air, wind blast and 'G' forces.

Marine Capt. Michael Oginsky poses with his LASIK refractive surgery team post op. From left to right: Chris Baldonado; Oginsky; Butch Tinga; Capt. Steve Schallhorn, MD; and Wendy Rossi, RN. Although not a new procedure, Oginsky is the first Naval Aviator to undergo corrective eye surgery. (Photo courtesy of LCDR Tyson Brunstedder)

Finding an acceptable candidate for this first group required specific criteria to be met.  Medically, the candidate needed a treatable refractive error and be correctable. Militarily, criteria requirements included a Class II naval flight officer who could be put in a 'down status' for 30 days without impacting their squadron.

Oginsky's vision and timing were perfect for the clinical trial.

During a pre-operative consultation, Oginsky said any concerns he had had vanished.

"The doctors were confident that LASIK and aviation could come together,"said Oginsky.

Oginsky, who had the procedure on both eyes, said the difference was apparent immediately.

"I was definitely seeing better right away, and with in four hours my vision was 20/20," said Oginksy.  "At the 24-hour mark, my vision was better than 20/20."

According to Lt. Cmdr. Tyson Brunstetter, Research Director one of the biggest concerns that was successfully addressed in a series of NMCSD studies has been the re-adhesion of the flap.  Oginsky said at the one week follow-up doctors said the surgical flaps had sealed.

The trials are a big step forward in what is a common procedure.  Oginsky is already able to see farther out with crisper, clearer vision.  He hopes in the next two to three years enter pilot training.

News Courtesy of: MC1(SW) Cindy Gill, NMCSD Public Affairs

 

STAAR Surgical Announces First Myopia Treatment Using the VISIAN ICL(TM)

January 11, 2006 06:30:00 AM ET

- STAAR Surgical VISIAN ICL Offers Adults a Minimally Invasive Alternative for Correction of Nearsightedness

- First Procedure in U.S. After Clinical Trials; Patient's Eyesight Improved From Inability to See Largest Letter on Vision Chart to 'Better than 20/20'

MONROVIA, Calif., Jan. 11 /PRNewswire-FirstCall/ -- STAAR Surgical Company STAA, today announced that the first VISIAN ICL(TM) (Implantable Collamer Lens) has been surgically implanted in the U.S. since the Food and Drug Administration approved the premarket approval application for the lens in December 2005. Dr. John Vukich, ophthalmic surgeon and medical director at the Davis Duehr Dean Medical Center in Madison, Wisconsin, performed the procedure on January 10, 2006, which resulted in a dramatic improvement in the patient's vision. The patient had previously only been able to count fingers when placed one foot in front of her. Dr. Vukich reported that post- operatively her vision was "better than 20/20."

The VISIAN ICL is the only foldable, minimally invasive lens approved for the correction of myopia, or nearsightedness, in adults.

During the six-minute, topical anesthetic procedure, Dr. Vukich made a micro incision to allow positioning of the implant behind the iris, or the colored part of the eye. "The 36-year old female patient had -9.5 diopters of myopia before the procedure and was unable to see the largest letter on the standard vision chart," said Dr. Vukich. "Post-operatively, the patient was able to see letters smaller than the 20/20 visual acuity would allow. She showed significant improvement instantaneously, and within one hour following the procedure was able to see better than 20/20 without eyeglasses."

"Immediately after the ICL procedure, the patient sat up and read the time off the clock across the room," added Dr. Vukich. "The VISIAN ICL is an exciting technological advancement and it will allow a great number of individuals suffering from nearsightedness to enjoy clear vision without glasses. The ICL has been shown to be a safe, minimally invasive procedure that has produced outstanding clinical outcomes, and it is a significant improvement to the ophthalmic surgeon's arsenal."

The Company indicated that Stephen Slade, M.D., in Houston, Texas; David Schneider, M.D. in Cincinnati, Ohio; and Paul Dougherty, M.D., in Los Angeles, California, would also be performing VISIAN ICL surgeries this week.

STAAR cautions that individual patient results will vary. Not all patients will achieve 20/20 vision or better.

About the VISIAN ICL
Made of a highly biocompatible Collamer(R) material containing a small amount of collagen, the VISIAN ICL's unique lens design allows for an incision 50% smaller than competing technology and for a more aesthetically pleasing outcome, because the lens is placed behind the iris. The procedure is also reversible, as the lens can be removed without permanently altering the structure of the eye.

Currently, more than 860 surgeons in the U.S. have completed the first phase of training toward becoming certified to conduct the procedure. Doctors familiar with the technology have noted the ICL's stability, the safety of the procedure, superior clinical outcomes and high patient satisfaction rate. In addition to the U.S., the ICL is approved for sale in 41 countries (including the European Union) and has been successfully implanted in more than 40,000 eyes worldwide.

The VISIAN ICL is a refractive phakic implant intended for placement in the posterior chamber of the eye. The approved models are indicated for the correction of myopia in adults with myopia ranging from -3.0 to less than or equal to -15.0 diopters, with astigmatism less than or equal to 2.5 diopters at the spectacle plane, and the reduction of myopia in adults with myopia ranging from greater than -15.0 to -20.0 diopters with astigmatism less than or equal to 2.5 diopters at the spectacle plane, in patients 21 to 45 years of age with anterior chamber depth (ACD) 3.00 mm or greater, and a stable refractive history within 0.5 diopters for one year prior to implantation. The safety and effectiveness of the VISIAN ICL is not established for patients who fall outside these requirements. Additional information on the safety and effectiveness of the VISIAN ICL will be available on the FDA website at www.fda.gov/cdrh/pdf3/p030016.html.

About STAAR Surgical
STAAR Surgical is a leader in the development, manufacture and marketing of minimally invasive ophthalmic products employing proprietary technologies. STAAR's products are used by ophthalmic surgeons and include the revolutionary VISIAN ICL as well as innovative products designed to improve patient outcomes for cataracts and glaucoma. STAAR's ICL has received CE Marking, is approved for sale in 41 countries and has been implanted in more than 40,000 eyes worldwide. More information is available at www.staar.com.

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CONTACT: Investors EVC Group Douglas Sherk, 415-896-6820	Media EVC Group Steve DiMattia, 646-277-8706
Jennifer Beugelmans, 415-896-6820 © 2006 PRNewswire