As a contract developer and manufacturer, we had an important role in the development of this handheld disposable hysteroscope, starting from the product’s first prototypes and iterating to the final system, conducting its early clinical studies at Semmelweis University in Budapest.
Since the market approval of the system, we are responsible for the commercial-scale production of the disposable hysteroscope devices and a few key subassemblies of the controller. We were able to scale our manufacturing output in lockstep with the rapidly rising market needs for Meditrina hysteroscopes.
Aveta (Meditrina Inc.)
The Aveta System removes uterine fibroids, polyps and/or retained products of conception (RPOC) from the uterus with a minimally invasive hysteroscopic approach with no incisions. This simple and quick surgical procedure will return patients to enjoying regular daily activities within a few days. Hysteroscopic procedures are also the preferred polyp and fibroid treatment for women of child-bearing age.
We played a key role in the development of the controller and handheld unit, with our involvement starting with the first prototypes and continuing throughout the final testing stages, and also manufacturing devices for initial tests and clinical studies. As part of this process, we supported the compilation of the required regulatory submission documentation for obtaining FDA approval. We were also involved in the production of the device’s first generation and supported the manufacturing transfer process.
Minerva EAS (Minerva Inc.)
Minerva EAS is a surgical system designed for the controlled ablation of the endometrium, the innermost layer of the uterus. The basic principle on which this technology operates is the ionization of argon gas which in turn facilitates the creation of plasma in the silicone membrane that is located at the distal tip of the device. This plasma energy is then used for ablation. The system is designed for providing a safer and a less invasive method for treatment, reducing the number of patients requiring a full hysterectomy.
We played a key role in the development of the handheld device’s probe, controller and fluid management system. We were first engaged to develop the product’s first prototype and carried it through to its clinical study stage.
We were involved in the clinical studies conducted at Semmelweis University in Budapest, and manufactured approximately 1000 devices for testing and clinical trials. We provided documentation for the regulatory approval process and FDA clearance was granted in less than eighteen months following the start of the project. After obtaining the FDA’s approval, IoGyn was acquired by Boston Scientific.
Symphion (IoGyn Inc.)
The Symphion System is a next-generation surgical system designed for the hysteroscopic removal of fibroids (myomas) and polyps, combining bladeless resection with intrauterine pressure-regulated saline circulation. This system aims to preserve a woman’s ability to bear children by making the removal of symptomatic fibroids and polyps both safer and less invasive compared to common surgical approaches.