LaHaye Medical Device Cleared by FDA.
September 30, 2004
For Immediate Release
The press release can be found at:
LaHaye Medical Device Cleared by FDA.
New Surgical Ocular Surface Management System Designed by Louisiana Surgeon Unveiled in Paris at International Medical Meeting.
(Opelousas, LA.) - Louisiana physician, Leon C. LaHaye II, M.D., introduced a new LASIK technology at the ESCRS meeting in Paris last week. The LaFaci(tm) Surgical System, www.lafacilasik.com, was developed by Vision Pro, LLC and the name LaFaci(tm) is short for LASIK Facilitator.
The LaFaci(tm) Surgical System provides a multiplicity of specialized functions to the surgical field through a single handpiece facilitating the entire second stage of the LASIK procedure. The LaFaci(tm) Handpiece is placed on the patient's eye prior to lifting the flap and remains positioned until flap fixation is assured, providing (11) eleven specialized functions. Additionally, the LaFaci(tm) Surgical System has been FDA 510(k) cleared and European Approved.
LASIK surgery is the most frequently performed refractive procedure for correcting nearsightedness, farsightedness, and astigmatism. Its popularity increased over the late 1990's, rapidly replacing Radial Keratotomy and excimer laser surface ablation procedures. The LASIK operation gained the rapid acceptance of refractive physicians and patients over the latter procedures because it provides much more rapid, stable, and less painful visual recovery.
LaFaci(tm) is designed so that functionality and standardization of the LASIK operation are achieved using a new surgical ocular surface management system which uniquely combines surgical field containment, ocular fixation, ciliarly vessel tamponade, temporary flap placement, proactive surgical field fluid removal, plume evacuation, stromal bed hydration control, irrigation, aspiration, and flap reposition and adherence.
LASIK Surgery Procedures Advance with Technology
Over recent years, advances in technologies have contributed to making refractive procedures more predictably safer. In the mid to late 90's, the keratotomy (stage I) was considered to be a "challenge" for the LASIK surgeon. Today's automated mechanical micro-keratome(s) (blade) and laser keratome(s) (bladeless) allow LASIK ophthalmologist to create the corneal flap with more predictability and consistency, substantially reducing flap related complications. Similarly, the earlier first, second, and third-generation commercial excimer laser systems lacked the more advanced features found on today's lasers. (The use of the excimer laser is only one aspect of Stage II of the LASIK operation.)
Today's keratome(s) (bladeless or blade) and commercial excimer lasers are equal and are capable of providing similar, reproducible results. It is the opinion of leading ophthalmologists and researchers that the future the LASIK procedure will be further improved by reducing complications associated with Stage II of the LASIK operation.
Stage II of the LASIK operation is much more dynamic and involves a multiplicity of procedures that requires consistency, standardization, and strict adherence to basic surgical principles and techniques to avoid less than desired outcomes. Stage II begins the moment the corneal flap is reflected (opening the incision) and is completed with the corneal flap returned and sealed in its original position (closure of the incision): surgical incision exposure to surgical incision closure.
LaFaci(tm) LASIK Compared to Conventional LASIK
In conventional LASIK numerous techniques, methods, and instruments are employed by LASIK surgeons to perform all aspects of the multitasked Stage II. There is considerable non-standardization (variability) and inconsistencies in the performance of the numerous steps of Stage II of conventional LASIK.
When performing conventional LASIK, the surgeon and surgical assistant utilize various techniques, methods, and instruments to complete all steps of the operation.
"LaFaci(tm) LASIK utilizes the LaFaci(tm) Surgical System that is designed to provide a multiplicity of specialized functions to the surgical field through a single handpiece facilitating the entirety of Stage II of the LASIK procedure, thereby allowing for improved standardization," said LaHaye.
The LaFaci(tm) Handpiece is placed on the patient's eye prior to lifting the flap and remains positioned throughout the entire Stage II, providing numerous specialized functions to facilitate and complete the LASIK operation.
"LaFaci(tm) is designed to 'help the doctor help the patients,'" said Leon C. LaHaye II, M.D., Vision Pro, LLC founder and well-known eye surgeon. "The hope is that LaFaci(tm) LASIK will result in a win-win for both patient and the LASIK physician."
LaHaye Engages University of Louisiana at Lafayette Scientists
LaHaye began the development process for LaFaci(tm) when he initiated the patent application process in 1999 for the new surgical ocular surface management system. Upon being awarded the patents, LaHaye developed LaFaci(tm) at Vision Pro, LLC's innovative manufacturing facility in Opelousas, Louisiana and then secured several additional patents for the medical device. Extensive testing and data analyses were conducted in conjunction with academic and research scientists at the University of Louisiana at Lafayette.
Two UL Lafayette researchers were instrumental with assisting Dr. LaHaye in obtaining FDA 510 (k) clearance for a device that uniquely combines several functions to facilitate ophthalmologists during LASIK surgery.
The LaFaci(tm) Handpiece, designed by Lafayette surgeon Dr. Leon
LaHaye, provides (11) eleven functions thereby comprehensively facilitating and allowing for the standardization of the LASIK procedure, which uses lasers to correct vision abnormalities.
LaHaye consulted UL Lafayette engineering professors Fred Farshad and Herman Rieke after the U.S. Food and Drug Administration asked for additional data before it would approve the surgical system.
The professors, along with a team of three graduate students in UL
Lafayette's Chemical Engineering Department initiated a fluid flow-testing program to examine the ease of liquid mobility in the LaFaci(tm) system.
Using eyes harvested from dead pigs, the university researchers addressed irrigation, fluid and plume aspiration and air delivery conditions. The UL
Lafayette team's findings were integrated into a final report presented to the FDA. Less than two weeks later, Dr. LaHaye received FDA 510 (k) clearance for the LaFaci(tm) device.
Farshad, Rieke and their team conducted their research at the LaHaye Clinic in Lafayette and at UL Lafayette's College of Engineering.
"This has been a great collaboration," said LaHaye. "The University provided Vision Pro with some tremendous resources and scientific talent. The entire process to secure FDA 510 (k) clearance and European Approval was certainly facilitated by Drs. Farshad and Rieke and the University's academic and scientific community."
For a comprehensive discussion and illustration of conventional LASIK and LaFaci(tm) LASIK go to (http://www.lafacilasik.com.)
About Vision Pro, LLC
"As a traditional, yet innovative manufacturing company, Vision Pro, LLC restricts its services to its core competencies and concentrates on producing state-of-the-art ophthalmic surgical instruments and medical devices that are designed to "help the doctor help the patient". This is achieved by establishing and maintaining genuinely close relationships with its physician clients that have preserved the traditional and reliable conviction...because patients come FIRST.
In fact, in past years we have deliberately avoided being caught up in the superficial hustle and bustle that, in some circumstances, has taken over the practice of medicine. We prefer instead to cultivate and further strengthen our core competencies, designed to manufacture equipment, allowing the physician to standardize and maximize his or her overall skills and talents.
At the same time we are aware, of course, that preserving tradition and reliability must under no circumstances obstruct our efforts to further improve the products we offer. That is why we invest heavily in technology and state-of-the-art information to provide both our physician clients and their patients with the tools and educational materials to meet exacting needs and maximize outcomes.
We are confident that in doing so we are best able to honor the great trust that our client physicians and their patients place in us."
Contact: Julie Calzone/CEO, Calzone
337.235.2924 Ext.3 firstname.lastname@example.org