"With the now CE marked medical hydrogel, which will be distributed under the product name "mediNiK", it is possible to remove even the smallest kidney stone fragments without additional complicated procedural steps during endoscopy", explains Manfred Peschka, Managing Director of Purenum GmbH. "After removing the large kidney stones, the remaining residual fragments are encapsulated with the "mediNiK" hydrogel. The resulting conglomerate of hydrogel and stone fragments is large enough to be easily removed with standard instruments", Peschka describes the novel procedure. "The successful certification and the resulting declaration of conformity guarantees the safety and performance of the product. It is the most important regulatory hurdle for the use of a medical device. To provide all German patients with access to this effective medical method, our next step will be to clarify the coverage of the treatment by health insurers. We are planning another six months for this process so that “mediNiK” can be used for all patients in Germany at the beginning of 2022", Peschka is convinced.
"Adhesive development for use in medical technology is a research focus at Fraunhofer IFAM. Before a development can go into use as a medical product, many years of preliminary research have been carried out and numerous hurdles must be overcome before certification can be obtained. We are therefore even more pleased, together with the Purenum GmbH research team, about this important success," says Prof. Bernd Mayer, Director of Fraunhofer IFAM. "We experienced the beginnings of the research project at the institute and saw the great commitment with which the former employees of Fraunhofer IFAM drove the work forward and applied their expertise in a goal-oriented manner. With this energy, the team has successfully made the long journey from the product idea to a professional medtech company. We are convinced that "mediNiK" will decisively improve the removal of kidney stone fragments", says Mayer.
MEDICA-tradefair.com; Source: Fraunhofer Institute for Manufacturing Technology and Advanced Materials IFAM