Innoventa Medica’s Mission is to provide, innovative, safe and effective medical technology solutions serving patients undergoing surgical procedures, where an unmet medical need exist.
Seroma Set™ is a novel sterile single use closed system for draining of Seroma fluid after breast surgery. The product is CE marked and is currently marketed in Denmark. During the current standard procedure for seroma aspiration, the nurse or surgeon applies a 60 ml syringe with a needle and aspires the seroma into a beaker. As seroma contains in mean 200ml seroma, the aspiration needs to be performed several times during the procedure. The repeated separation of syringe and needle carries a potential risk of compromising the sterility of the procedure,. Furthermore, the current procedure implies risk for environmental contamination, is inconvenient and bothersome for the patient, is time-consuming and not user-friendly. Seroma Set™ is a closed system consisting of a handle on which both the needle and the vacuum can be controlled. The system is connected to a vacuum bottle.
- Closed system, securing sterile procedure
- Environmental safe, due to elimination of contamination from contaminated fluid
- Patient friendly
- User friendly - system can be operated with one person and requires no force to be applied by the operator.
- The closed system and ease of handling may reduce the rate of infection.
- Easy to be adopted and accredited as standard operation procedure.
The product is protected by patent applications (world wide).
In EU it is classified as a Class I device. For the US a 510 K approval will be required.
Co-founder and CEO, Niels Erik Holm, is the inventor of several multi million dollar products (Insulin Infusion Set, NovoLet, Vivostat System) and are the inventor of more that 20 worldwide patent Co-founderJohn Hørby, MD, Consultant in Breast Surgery, is the co-inventor of two medical devises for single use (Naso-Fix [danish], Drain-Fix [danish]) Co-founder and Chairman of the Board, Bo Jesper Hansen, MD Phd, has several years of entrepreneurial and management experience within the pharmaceutical industry.
For Innoventa Medica, quality is a key word and we are
constantly working to maintain and improve quality.
We are Certified by LRQA in relation to the Quality Management System standard 13485:2012 and Medical Device Directive 93/42/EEC.
If you need a company that has extensive experience in the development, CE marking and start-up production of new medical devices, Innoventa Medica will be an obvious partner.