BVI Completes Enrollment of Finevision HP IDE Clinical Study

BVI announced it has completed enrollment of its US Investigational Device Exemption (IDE) clinical study for its latest hydrophobic trifocal IOL, 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 IOL, with the results to form the basis for a regulatory submission to obtain marketing approval in the United States.

“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,” Devang Shah, PhD, BVI Senior Vice President, Business Operations, said in a company news release.

“Achieving this milestone represents an exciting and significant step towards bringing our IOL technology to U.S. patients and surgeons," said Shervin Korangy, BVI President and CEO. "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.