BVI, a diversified global ophthalmic device company, today announced it has completed enrollment of its U.S. investigational device exemption (IDE) clinical study for its latest hydrophobic trifocal intraocular lens, Finevision HP.
The milestone marks the final implantation of the 539th patient enrolled in the prospective, multicenter, randomized, masked, controlled IDE clinical study. Patients will now be followed to evaluate the safety and performance of the Finevision HP intraocular lens, with the results to form the basis for a regulatory submission to obtain marketing approval in the United States.
BVI has one of the most comprehensive ophthalmic surgery portfolios in the industry and is committed to expanding its availability globally.
“With the IDE clinical study completing both the enrollment and implantation phase in less than 12 months, we are pleased with our momentum and acknowledge the patients and clinical investigators for their commitment to the trial,” said Devang Shah, PhD, BVI senior vice president, Business Operations.
Shervin Korangy, BVI president and CEO, added, “Achieving this milestone represents an exciting and significant step towards bringing our IOL technology to US patients and surgeons. This trial is the first of a series of studies on innovative ophthalmic devices that BVI will be undertaking in the U.S. in the coming years.”
Finevision HP is a hydrophobic trifocal IOL and the third generation in the Finevision family, featuring BVI’s proprietary hydrophobic material and two novel patented CoPODize technologies enabling convolution and apodization concepts on the entire optic surface.
CAUTION
Finevision is CE marked since 2010. Finevision HP is an investigational device in the United States. Limited by Federal Law to investigational use; Pending PMA, not available for sale within the United States.