STAAR Surgical, a US-based ophthalmic products manufacturer, has obtained regulatory clearance from India’s Central Drugs Standard Control Organisation (CDSCO) to market its Visian Implantable Collamer Lens (ICL) with CentraFLOW technology.
Having received Korean clearance recently, Staar Surgical now expects the Indian approval to boost its market share in the Asia Pacific region.
The regulatory clearances for the Visian ICL with CentraFLOW will now be expanded from -0.5 diopter to -18.0 diopters on the myopic range and +0.5 cylinder power to +6.0 for the Toric ICL models.
CentraFLOW technology optimises fluid flow in the eye by utilising the KS-AquaPORT technology in the centre of the ICL optic.
CentraFLOW also removes the requirement for a YAG peripheral iridotomy surgical procedure days before the ICL implant, ultimately providing comfort and convenience to patients.
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To date, approximately 25,000 implants of the Visian CentraFLOW technology have been successfully performed in Europe.
Staar Surgical Asia Pacific region president Don Todd noted that the firm’s marketing partner, Spica Medical, has seen a lot of anticipation in the market for the CentraFLOW technology as inquiries from surgeons and clinics over the past few weeks has been tremendous.
"With this approval in India, we can now leverage this growing acceptance to further penetrate a significantly large market," Todd added.
In the first half of 2013, Visian ICL with CentraFLOW contributed to the 54% growth in European markets. During the past four years, the compound annual growth rate (CAGR) for the Visian ICL has been 48% in India.
Nethradhama Hospital chairman and managing director Dr Sri Ganesh noted that Staar Surgical has developed Visian ICL with CentraFLOW, which improves patient safety and efficiency for the surgeon.
"The patient experience now with the Visian ICL CentraFLOW technology will be as good as or even better than LASIK," Dr Ganesh added.