Iridex laser delivery system gets transatlantic clearance

04 Dec 2012

Multi-spot “TxCell” system is designed to improve laser treatment of serious retinal diseases.

A new laser scanning system developed for ophthalmology applications by US-based Iridex has gained clearance on both sides of the Atlantic.

The Californian company said that the “TxCell” system, designed to help surgeons treating serious retinal diseases to complete procedures more quickly, had received both Food & Drug Administration (FDA) 510(k) approval in the US, and CE clearance in Europe.

The system speeds up procedures by delivering the surgical laser in a multi-spot scanning mode, and can now be used in a variety of photocoagulation procedures that Iridex is targeting with its proprietary “MicroPulse” technology.

“Broadening market acceptance for medical technologies typically involves effective clinical results, ease of use for the physicians and more efficient use of time,” said Will Moore, the Iridex CEO, in a statement announcing the development.

“TxCell can deliver all three benefits and is an important step in accelerating the adoption of our proprietary MicroPulse technology as it applies to several clinical procedures," he added.

Iridex has been focusing largely on ophthalmology since selling its aesthetic laser business to Cutera earlier this year. It has high hopes for the MicroPulse laser platform, which allows users to control the laser pulse duration and separation according to the needs of different patients and conditions.

The technology is used for selective coagulation of blood vessels in the retina as a treatment for diabetic retinopathy, with pulses from the laser separated to allow the target tissues to cool down, which the company says minimizes any laser damage. Iridex also touts the approach as a “tissue-sparing” therapy for glaucoma, to reduce high pressure inside the eyeball.

The firm says that when combined with either its “IQ 532” or “IQ 577” lasers, the TxCell scanner provides ophthalmologists with a highly versatile system featuring three laser modalities – and adds that initial shipments have commenced with orders from a number of different countries.