CDSCO Approves Visian ICL With CentraFLOW Technology
Staar Surgical has received regulatory approval to market its Visian Implantable Collamer lens (ICL) with CentraFLOW technology from the Central Drugs Standard Control Organization (CDSCO) in India. The approval expands the market opportunity for the Visian ICL as the range of refractive errors treatable has significantly increased. The expanded range for the Visian ICL with CentraFLOW will now go from -0.5 to -18.0 diopters on the myopic range and +0.5 cylinder power to +6.0 for the Toric ICL models.
The device was recently approved in Korea. According to the company's marketing partner, Spica Medical, there has been a lot of anticipation in the market for the CentraFLOW technology, as inquiries from surgeons and clinics over the few weeks preceding Staar's August 19 announcement have been high. The Visian ICL CentraFLOW technology was launched from a marketing perspective at two recent major meetings in India. The first was the Intraocular Implant and Refractive Society, India (IIRSI) meeting, held from July 6-7, in Chennai, India. The second was the XXI Annual Conference of the Bombay Ophthalmologists Association, held from August 2-4, in Mumbai, India.
The CentraFLOW technology utilises the KS-AquaPort in the centre of the ICL optic, to optimise the flow of fluid within the eye. This proprietary technology eliminates the need for the surgeon to perform a YAG peripheral iridotomy procedure days before the ICL implant, thus eliminating an additional procedure and office visit. This results in more comfort for the patient and a more convenient, efficient ICL experience for both the patient and the surgeon.