French company Provepharm, specialized in the development and marketing of pharmaceutical products, has announced that ProveDye, its first Class IIa medical device, obtained the CE mark in December 2014. In addition, Provepharm’s quality management system has been awarded ISO 13485: 2012 certification. This certification covers the design, production control and distribution of sterile solutions used as an aid to visualization in surgical procedures.
ProveDye allows the delineation or visualization of anatomical structures and anatomical disorders by colouration. It helps to detect seals, leaks and fistulae and to test sutures patency. ProveDye is a 0.5% sterile solution of Proveblue (a European Pharmacopeia compliant methylene blue dye produced in accordance with cGMP). ProveDye can be used for nonspecific coloration for surgical procedures in areas such as gastroenterology, gynecology, urology or ENT.
Surgical visualization accounts for almost 70% of hospital blue dyes uses. These blue dyes, particularly methylene blue, have long been used off-label or have been indicated solely in specific surgical applications. Now ProveDye meets surgeons’ needs by formalizing the extensive use of methylene blue in surgery.
The new ProveDye medical device will be launched on the European market by Q1 2015. It will be offered to both general and specialist surgeons. ProveDye is packaged in 2 mL ampoules. “ProveDye is perfectly in keeping with our strategy of developing and marketing products based on our methylene blue compound. It meets rigorous industry standards. This approach is creating value for both the patients who will benefit from this new product and the company,” said Michel Féraud, chairman of Provepharm and the Provence Technologies Group.