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. (Nasdaq: ILSE) today confirmed the Navy's announcement that the first LASIK procedure using the IntraLase Method has been performed on an aviator as part of a new Bureau of Naval Medicine project. 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.
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.
SOURCE IntraLase Corp.
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