Custom-made Lenticule for Keratoconus

Case Studies >>

“Research Innovation to Clinic” for Custom-made Lenticule of Porcine Collagen for keratoconus

A European medical device company developed an innovative custom-made lenticule made of collagen of porcine origin for the treatment of keratoconus, a progressive eye disorder that causes the cornea to thin and bulge into a cone-like shape, leading to vision distortion. The uniqueness of this product was that each device was custom-made for each patient, requiring a special approach for regulatory clearances and monitoring.

The company engaged Nextvel to help with regulatory strategy, regulatory clearances, and clinical trial management for this groundbreaking product. They also required assistance with the import of the implant on a named patient basis.

Nextvel facilitated an Investigator Initiated Study at one of the leading Eye Institutes in India, providing comprehensive support throughout the trial. They utilized the latest Regulatory Compliant EDC Solution for efficient and accurate data management.

This one-year follow-up study was successfully completed within the designated time frame, demonstrating Nextvel’s expertise in navigating complex regulatory landscapes and efficiently managing clinical trials for innovative medical devices. This success has paved the way for further collaboration between the European company and Nextvel, as they continue to bring cutting-edge ophthalmic solutions to patients suffering from keratoconus, potentially improving their vision and quality of life.

Nextvel was able to get a response from the Indian regulators on the exemption of manufacturing and import license for a custom-made device.