On September 16, 2022, Vita Group achieved a historic moment. We’re excited to announce that StingRay and Brekka are FDA listed and available for sale in the USA! These devices aid in the delivery of various types of implants. So, without further ado, let’s get into the specifics of what impacts these devices make in the medical field.
Brekka is a sterile, configurable device designed to assist in surgeries involving the placement of a variety of implants at a range of implant insertion locations. Brekka's patented trapezoid design allows up to four configurations for surgeons to choose from based on the size and location of a specific implant delivery. Brekka is intended for single patient use only, but depending upon implant type and insertion location, the device can be configured to be used for two insertions on the same patient in a single procedure. By following the directions for your own customized implant device, users will find the device efficient and easy to use.
Stingray is intended to facilitate the delivery of silicone gel implants by providing a shell-tissue interface with less friction during insertion of the implant. It is also intended to facilitate implementation of a contact free implant insertion. With the device laid out, the user can see each step clearly numbered and a spot in the middle for the implant. The StingRay is designed to effortlessly deliver the implant in smaller incisions in surgeries while maintaining sterility. There is no cutting necessary with the StingRay and can even be used one handed!
Both Brekka and StingRay change the standards to facilitate delivery of implants during surgery. What’s even more impressive is the quick rate in which these devices came to phase V, distribution. Vita Group took on these projects in 2019, meaning we brought both Brekka and StingRay to FDA listing in just 3 years. It’s typical in the R/D medical device industry for projects to take 7 to ten years to reach the market, and we realize this timeline is an extremely long time to wait for a product to come to commercialization, especially for the inventor. This is why Vita Group standardizes all projects to fit a 6-month timeframe for Phase 0 and Phase 1. From Phase 2 to Phase 5, we estimate 2 years or less, depending on the project. Our goal is to bring medical device innovations to market at an accelerated rate, while providing regulatory costs/pathway, IP analysis, COGs manufacturing (international or domestic), a business plan/business strategy, and prototypes (version 1 to version 10) for the project as fast as possible. We are proud of the work we do at Vita Group and can’t wait to show everyone what the future holds for us!