Provepharm Launches its First Medical Device in Europe

French pharmaceutical firm Provepharm is entering the medical device arena.

The company is launching ProveDye, a Class IIa medical device, in Europe, having successfully obtained the CE Mark. In addition, Provepharm’s quality management system has been awarded ISO 13485: 2012 certification, covering 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 coloration, according to the company. It helps to detect seals, leaks and fistulae and to test sutures patency. ProveDye is a 0.5 percent 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 ear, nose and throat procedures.
 
Surgical visualization accounts for almost 70 percent of hospital blue dyes uses, Provepharm claims. 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.
 
Packaged in 2 millileter ampoules, ProveDye is offered to both general and specialist surgeons.
 
“ProveDye is perfectly in keeping with our strategy of developing and marketing products based on our Proveblue 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.
 
Provepharm is a subsidiary of Provence Technologies. It is specialized in the development and marketing of pharmaceutical products from active substances synthesized and patented by its parent company. The company is based in Marseille, France.