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Coherent's Selecta 7000 laser and SLT receive FDA clearance

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SANTA CLARA, Calif. — Coherent (Nasdaq: COHR) announced Apr. 17 that the U.S. Food and Drug Administration (FDA) has cleared its 510k application to market the Selecta 7000 Glaucoma Laser System. The Selecta 7000 is specifically designed to perform selective laser trabeculoplasty (SLT), which incorporates a new patent protected technique for the treatment of open angle glaucoma.

SLT lowers intraocular pressure by using short pulses of an Nd:YAG laser to target melanin-containing cells in the trabecular meshwork, resulting in increased fluid outflow. The limitations of argon laser trabeculoplasty (ALT) are primarily related to its coagulative effect, which leads to scarring of the trabecular meshwork. SLT retains the therapeutic benefit of laser treatment -- reduced intraocular pressure, without the collateral thermal damage to non-melanin containing cells and to the trabecular meshwork structure.

The treatment was devised by Mark Latina, M.D. at Wellman Laboratories, Massachusetts General Hospital in Boston.

Dr. Latina spoke about the procedure during the International Glaucoma Symposium in Prague, Czech Republic earlier this year.

During the non-randomized, prospective, multi-center trial, 120 eyes of 120 patients with uncontrolled open angle glaucoma were treated with the SLT procedure. After 26 weeks, 101 patients had completed the study. Prior to the study 45 eyes were on maximum tolerated medications and 56 eyes had previously failed ALT.

The SLT procedure Dr. Latina used required a 532 nm frequency doubled, Q-switched, Nd: YAG laser with a 3 nsec pulse duration and a 400 µm spot. A total of 50 spots were placed over 180 degrees of the trabecular meshwork at energies of 0.4 to 1.4 mJ/pulse.

The mean IOP reduction at 26 weeks was 5.2 mmHg for the medication group and a mean of 4.4 mmHg for the ALT group. In the medication group 75% of patients responded to treatment with a reduction of at least 3 mmHg and 66% responded by the same level in the ALt Group. There were no adverse effects reported.

Dr. Latina concluded that SLT appeared safe and effective for lowering IOP in patients with uncontrolled open angle glaucoma and patients with previously failed ALT.

Coherent has acquired an exclusive license from the Massachusetts General Hospital to commercialize SLT and market the relevant laser technology. Coherent developed the Selecta 7000 specifically for SLT.

In the next few weeks, Coherent Medical Group will be joining forces with ESC Medical Systems, Ltd. (Nasdaq: ESCM), and thereafter the combined company will change its name to Lumenis, derived from the lumen, the Latin for light.

Coherent will continue to benefit from the SLT technology as the owner of approximately 16.5% of the equity in Lumenis.

Coherent Medical Group will be exhibiting the Selecta 7000 Glaucoma Laser System at the American Society of Cataract and Refractive Surgery in San Diego, California April 28 through May 2. The company will also sponsor a physician symposium on SLT with Dr. Latina on Sunday, April 29.