Quantel’s Solutis Granted FDA Clearance

Quantel Medical, a developer of ophthalmic ultrasound and laser devices, has received U.S. Food and Drug Administration (FDA) approval for its selective laser trabeculoplasty (SLT).

The FDA’s approval of Solutis follows the expiration of a patent issued to Massachusetts General Hospital, which restricted Quantel Medical and several other laser manufacturers from marketing SLT within the United States. Quantel has been providing SLT technology to customers outside the United States since 2007.

SLT is a first-line and adjunct therapy option for reducing intraocular pressure in glaucoma patients. The non-invasive procedure delivers targeted laser energy, inducing a regenerative response at the cellular level. Due to the laser energy’s gentle application, the treatment is repeatable, as well as not associated with the ocular and systemic side effects or compliance issues commonly linked to glaucoma drugs.

In use since 2007, Quantel’s Solutis laser offers several clinician-friendly features, facilitating easy integration into a hospital or clinical setting, according to the company. The design is adaptable to a physician’s current slit lamp, eliminating the need for dedicated space and lowering end-user cost. The compact design also allows for easy transport from room to room or office to office, and includes convenient storage accessories when not in use.

“This FDA market clearance of our SLT laser marks an important step in Quantel’s strategy for the U.S. market.” CEO Jean-Marc Gendre said. “Solutis has proven to be an attractive laser solution worldwide, and we are proud to now offer this laser alongside our line of multispot and YAG lasers. Our laser product line is designed to create combination systems, allowing for multiple laser applications in a single configuration, meeting the specific needs of each ophthalmology practice.”

SLT is laser treatment for primary open angle glaucoma (POAG). POAG patients are diagnosed with elevated intraocular pressure due to the lack of functionality in the trabecular meshwork. The 532nm laser targets and is absorbed by melanin-rich cells to induce a healing response, restoring functionality of the trabecular meshwork, and reducing and maintaining IOP. SLT is characterized as a gentle laser therapy in comparison to ALT or administration of medication, and is now considered effective for first-line, adjunct or secondary line of treatment. SLT has been available since 2001.

Founded in 1993 and headquartered in Clermont-Ferrand, France, Quantel Medical is a global ophthalmic medical device company that develops ocular disease treatments. The firm is a division of Quantel, a developer of solid-state lasers for scientific and industrial applications.